Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The qualified candidate will play a key role in building state of the art high throughput B cell cloning and sequencing pipeline in the cell-based Antibody Discovery Group. The candidate will collaborate with scientists within the organization to actively improve and drive therapeutic antibody discovery efforts by developing and employing state of the art molecular biology and sequencing technologies. The new hire will also participate in developing innovative technologies around cell-based therapeutic antibody discovery to address short comings of current technologies.

Responsibilities
Primary responsibilities include but not limited to:
- Establish efficient molecular cloning of immunoglobulin genes work flow on various species (e.g. hybridoma, single B cell)
- Establish and optimize rapid NGS workflow to study Immunoglobulin repertoire
- Analyze NGS data
- Drive novel antibody discovery technology development
- Establish robust method/process of genome editing (e.g. CRISPR)

Qualifications
- Ph.D. in immunology, molecular biology, virology, or computational biology with 3-5 years of industrial experience.
- Proven publication record in top tier journals
- Strong proven molecular biology skills
- Proven expertise in NGS Ig amplicon library generation and NGS sequencing work flow
- Hands-on experience in Illumina Sequencing platform
- Proven expertise in single B cell cloning in various species
- Knowledge and proven record of developing state of the art antibody discovery platforms
- Experience in applying proteomic in antibody discovery a plus
- Experience in various computational programming skills is a plus
- Strong organizational and project management skills
- Strong oral and written communication skills

PHYSICAL/MENTAL REQUIREMENTS
- Expertise in immunoglobulin alignment and sequence analysis packages
- Experience in molecular biology lab automation and process integration
- Expertise in single cell cloning and sequencing
- Experience in microfluidics is a plus
- Experience in proteomic is a plus
- Working experience in R, Perl, and other statistical packages is a plus

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy41MDM5Ni4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
We are seeking a bioinformatics expert to join the Global Biotherapeutic Technologies organization at Pfizer. The successful candidate will join a small team of computational biochemists and software engineers located in Cambridge, Massachusetts developing and using a broad array of computational tools to support cutting edge approaches for early stage biotherapeutic discovery.

Responsibilities
Responsibilities will include leveraging modern bioinformatics methods to enable biotherapeutic discovery across a broad range of disease areas and collaborating on software development projects aimed at analyzing and organizing the laboratory results that drive that discovery.

Qualifications
* MS (7+ years) or Ph.D. (0-4 years) in bioinformatics or a related field with research experience in academia or the biotech/pharmaceutical industry. Very strong computer skills are required.
* Strong software development skills including object-oriented programming and web application development.
* Understanding of relational database technology and competence with SQL.
* Some linux and web server administration skills.
* Experience in the analysis of Next Generation Sequencing results and understanding of the application of NGS to antibody discovery including phylogenetics, multi gene family analysis, and orthology assignment would be beneficial.
* Knowledge of antibody structure and sequence analysis.
* Strong background in molecular biology, biochemistry, or a related field.
* Familiarity with antibody screening and production technologies such as phage display, hybridoma generation, protein expression and purification, ELISA, FACS etc. The position will not involve actual laboratory work but it will be essential to be able to discuss results with project team members working in the lab.

PHYSICAL/MENTAL REQUIREMENTS:
Ability to develop sophisticated web-based applications and ability to perform complex bioinformatics analysis.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy43NzU2Ni4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
* Pfizer is developing small-molecule compounds to treat the basic defect in cystic fibrosis (CF) which involves misfolding of the CFTR chloride channel. We are seeking a Senior Associate Scientist to measure the activity of CFTR modulators using cell-based assays of CFTR function.
* The candidate will evaluate compounds using assays on primary airway cells from CF patients. The work will involve designing experiments, dosing compounds, performing assays, analyzing the results, and assessing the reproducibility of the data. The candidate will help optimize these assays and maintain prototype instrumentation. The candidate will work closely and collaboratively with other colleagues, requiring proactive communication and a teamwork mentality. Electrophysiology experience is desirable but not required. A strong candidate will have experience in mastering multiple cell-based assays in a drug discovery setting, preferably requiring the use of lab automation, and a demonstrated track record of learning and applying new skills.

Responsibilities
She/he will be responsible for delivering high quality data to the project team, presenting results at meetings, and adapting work flow to the needs of the program. The successful candidate will make use of problem solving, critical thinking, and effective written and oral presentation skills in a dynamic, multidisciplinary team environment.
* Design experiments in consultation with supervisor.
* Independently perform electrophysiology experiments.
* Report results at team meetings.
* Maintain a compound inventory and testing queue.
* 5) Train and collaborate with junior colleagues and student interns.

Qualifications
Required:
M.Sc. in Biology with 2+ years’ experience in a drug discovery setting or B.Sc. in Biology with 4+ years’ experience in a drug discovery setting

Physical Requirements:
Work involves sitting, standing, and walking.

Schedule/Travel Requirements:
Weekend work will be required occasionally. Occasional travel to meetings and conferences is involved.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy41ODY3MC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Pfizer Centers for Therapeutic Innovation (CTI) is an entrepreneurial network of partnerships with leading academic medical centers that aligns leading academic scientific and clinical experts with Pfizer's world-class scientists, drug development capabilities, and breadth of resources to speed the translation of breakthrough science into innovative medicines for patients. Pfizer scientists work directly with academic scientists assigned to sponsored programs toward the common goal of clinical application of targeted therapies.

Responsibilities
The candidate will be an essential member of the CTI-San Francisco Protein Group. He/she will use strategic thinking and expertise in molecular biology, protein expression, purification, and characterization in the discovery and optimization of antibodies and protein therapeutics.

The applicant will function as a member of multidisciplinary project teams. He/she will present results and recommendations at project team meetings. The candidate will collaborate closely with other members of CTI-San Francisco, CTI and Pfizer scientists at other sites, and our academic partners to ensure the team meets aggressive project deliverables and timelines. The candidate is expected to embrace and embody the entrepreneurial spirit and biotech-like culture, values and goals of the CTI and contribute to creating an exciting, collaborative, results-driven, and scientifically rigorous working environment.

Qualifications
Degree in Molecular Biology, Biochemistry, Bioengineering, or related life science discipline
-1+ years post Ph.D. experience, or 6+ years with BS./M.S., in laboratory research, preferably in an industry setting
-Creative and nimble thinking, and aptitude for learning new technologies essential
-Technical expertise in molecular biology required
-Experience in protein expression, purification, biophysical and biological characterization required
-Experience in phage and yeast library display technologies preferred
-Excellent written and oral communication skills
-Comfortable working in a multidisciplinary collaborative environment
-Conscientious laboratory citizen

PHYSICAL/MENTAL REQUIREMENTS:
Lab based position requiring strong analytical skills and ability to learn new technologies.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:
http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy45MTQ5MS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Primary Role:
The Regional Business Manager (RBM) is responsible for the implementation of the strategic initiatives developed by the leadership team. The RBM will develop strong working relationships with all physicians within their geographic responsibility who treat patients appropriate for the Shire Rare Disease portfolio of LSD products. This entails the promotion of medication for Gaucher Type 1 Disease and for Hunters Syndrome (MPS II) within approved labeling, to all targeted physicians and patient candidates. The RBM's primary objective is to identify providers managing patients and educate those providers regarding the benefits of using our therapies with appropriate patients. Further, once an appropriate patient is identified by the provider, assist the clinical staff with the steps necessary to get the patient on drug. This may include areas such as reimbursement, proper testing, and site of care determination.

Responsibilities:
This position will be responsible for all business related activities within their geographic responsibility, including achievement of sales goals, business planning, and expense control. The RBMs will call on Physicians and affiliated staff responsible for the care of patients.

Education & Experience Requirements:
* Minimum of a Bachelor's degree in business or science related field is required.
* Minimum of 8 or more years selling specialty biologics
* Candidates must demonstrate a consistent track record of success (Top 20% performance).
* President's Club or other top tier awards preferred.
* Biotech, biologics, and specialty pharmacy experience helpful
* Complex sales model experience is a requirement.
* Rare disease experience is a plus.
* Must be able to demonstrate strategic territory management successes

Other Job Requirements:
* Candidate must live in territory
* Must work evenings and weekends as needed
* Extensive travel required and varies by territory
* Candidates must possess a powerful sense of urgency, a strong desire for results and a strong work ethic.

About Shire:Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=bHZhaWwuOTM0NzYuMzE2N0BzaGlyZS5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The R&D Resource Management Specialist (RMS) team is a critical group in the ongoing adoption, utilization, and maintenance of Pfizer"s integrated operations and business planning environment, specifically the RAPID (Resource And Planning Insights for Decisions) ecosystem. RAPID is an essential component of the current business operations model including the processes, operations, and systems for the planning and management of R&D resources (dollars and FTEs).
The R&D RMS role is responsible for working directly with R&D business lines to support these customers" needs for successful resource management and planning. The RM specialist will work with business operations leads in each line for conducting resource management. The team enables the business utilization of RAPID tools and processes, ensuring that business needs and challenges are addressed. The RM Specialist has advanced understanding of resource management, project planning, understands in detail the pharmaceutical business processes and excels in bringing data together to solve customer problems. Enabling the business lines (RUs, BUs, PLs, etc.) to effectively and consistently utilize RAPID data to fulfill their needs is fundamental to achieving critical mass on data quality and enabling further downstream output uses and analytics.

Responsibilities
* Be the RM specialist and key Subject Matter Expert (SME) responsible for supporting operations customers in the lines (e.g., Partner Line Operations Lead, Research Unit Chief Operating Officer, Business Unit Portfolio Director, etc), ensuring business needs translated and delivered, resolving forecast discrepancies or inaccuracies, and providing support with complex analyses and scenarios
* Support customers with establishing completeness and accuracy of their line resource forecasts, which includes line activities, durations and links, attributes/drivers, Resource Work Type classification, FTE/$ forecasts, etc. for their group
* Supports customers in identifying and remediating issues that may result in inaccurate resource projections, including:
* Schedule and line activity completeness and accuracy
* Optimal set of algorithm drivers, completeness/accuracy of drivers, business process on defining/synchronizing key drivers/attributes
* Balance of algorithm usage and algorithm over-writes (manual entry)
* Changes in fundamental line alignment, structure or operating model
* Lead cross-functional limited duration teams established to resolve common RM challenges, assess options, and recommend options to senior leadership
* Assist customers with ad-hoc complex analyses, scenario planning, and 'one-time' analyses and leadership requests, e.g., impact on resource work types with different attrition models, cost scenarios for adding contract resources next year, expected capacity utilization for CROs or establishing a new pilot plant, cost/time comparisons of 3 Phase III scenarios, etc.
* Supporting the customer"s design/redesign of algorithms, drivers and templates to most completely and accurately represent their business, and ensure effective usage
* Assist business users with improving workflow efficiency within Planisware, including establishing and publishing of regular resourcing reports, views and filters of value to customer group as well as best practices for data viewing and maintenance
* Work with the Standards and Business Process team to ensure rule gaps and inconsistencies addressed and implemented across financial, activity tracker, portfolio inventory/attributes, project plans, etc. Make recommendations to Technical Change Control team on proposed enhancements to data structures, system functionality, business process etc.
* Represent the opinions and concerns of supported lines in forums tasked with developing system and business process improvements
* Assist in developing and delivering routine and custom training to RM users within supported lines

Qualifications
* B.S. Science
* Experience in project planning, resource forecasting, and resource management
* “Quick learner" in resource planning and forecasting system applications
* Detailed knowledge of Planisware preferred
* Analytical capabilities to interpret complex data and identify and resolve resource forecast discrepancies using Business Objects and Spotfire
* Strong customer focus and track record of developing trusting and constructive customer relationships
* Ability to simplify concepts and teach others on business usage and application

PHYSICAL/MENTAL REQUIREMENTS:
* Experienced with data analysis, process management and mathematical calculations

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
* 20% travel

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Please apply at: Application URL:
http://www.aplitrak.com/?adid=c3VzYW4ubS5kaXBhZ2xpYS43MDMyNS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Primary Role:
In collaboration with other Research and Development departments and applicable Business Unit partners,
* Responsible for the strategic and operational oversight, management, and delivery of a clinical development program or study in support of Shire's project strategy team.
* Authors, provides input, and/or oversees program and/or study level documents.
* Manages clinical outsourcing and may represent Clinical Programs on vendor oversight committees.
* Manages financial aspects of asssigned clinical program or study(ies) and provides to Development Team Lead.
* Responsible for strategic initiatives for process and business improvements.

Responsibilities:
50%:
* Provides functional input into the clinical development plan that aligns with Business Unit and product strategy.
* Collaborates with project physician, statistician and relevant functional areas on clinical trial designs.
* Provides strategic clinical programs input to Global Development Team (GDT) and Product Strategy Team (PST) as required.
* Co-leads the Development Operations Team (DOT) with the Global Clinical Development Lead (GCDL).
* May attend advisory panel meetings and regulatory agency meetings related to strategy of program, indication, and studies.
* Has in-depth knowledge of global regulatory/industry guidelines (e.g. ICH/GCP, promotional guidelines and labeling) to drive the clinical trial application process.
* Effectively represents the interests and perspectives of GCDO.
* Presents program/study(ies) overviews/status to senior management, cross functional team, and external partners as necessary.
* Co-leads inspection readiness activities, and acts as subject matter expert during regulatory inspections.

30%: Oversees or is responsible for:
* Program and /or study level document generation (e.g., synopses, ICFs, submission modules).
* Vendor selection including critical review of contracts, and/or work orders and management of ongoing performance.
* Collaboration with internal functions to ensure successful implementation of program/study.
* Presentations at relevant internal and external meetings
* Conducting study level training.
* Alignment of program for cross functional team regarding execution.
* Reporting of program / study milestones including mitigation.

5%:
* Works closely with Global Development Team Lead (GDTL), finance business partner, and/or study team(s) to generate and review forecasts and accruals for clinical studies.
* Ensures clinical program/study(ies) finances align with agreed development plan, and budget variances are escalated to management as appropriate.

10%:
* May assess long-range resource needs and make recommendations and allocations across program(s).
* Mentors junior staff.
* May be involved in interviewing, hiring, and training employees.
* Provides feedback on employee performance.
* Promotes Clinical Programs achievements within and across department(s).

5%:
* Reviews and contributes to strategy for operational efficiency.
* Collaborates on SOP development.
* Identifies or participates in innovative initiatives targeted to improve/revise clinical development processes.
* Ensures implementation and standardized use of Global Clinical Development Operations (GCDO) and/or other R&D tools.

Education & Experience Requirements:
* Bachelor's degree or nursing qualification is required. Scientific/health care field preferred but not required. Advanced degree preferred.
* Significant clinical research experience (8+ years) with evidence of increasing responsibility within a pharmaceutical company or CRO
* Global clinical trial research experience
* Experience leading cross functional teams
* Detailed knowledge of current regulatory requirements and guidelines governing clinical research
* Participation in marketing application review and submission is preferred.
* Experience managing financial budgets is preferred.

Other Job Requirements: Available for up to 25% domestic and/or international travel.

Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives. Shire is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by applicable law. US Applicants who require accommodation in the job application process may contact 484-595-8400.

Application URL:http://www.aplitrak.com/?adid=YWthbmVyLjQyMjE2LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Role Description
The Pfizer Clinical Supply Manufacturing group is currently recruiting 2 process engineers to join our group in Groton CT. The candidates will join a world class team that focuses on the manufacture of Clinical Supplies and enabling new capabilities. Our team manufactures drug product for the early phase clinical portfolio spanning all therapeutic areas (including Cardiovascular and Metabolic Disease, Inflammation and Immunology, Pain, and Oncology).

Responsibilities
Technical Support
* Responsible for manufacturing equipment and process development support which may include preparation and execution of qualification and validation protocols for equipment, mechanical, computer control and utility system. Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and manufacturing system.
* Ensuring maintenance of equipment and utilities is carried out to the required standard. The role will develop understanding of operating windows and the impact of process parameters on product development. Utilize the appropriate data gathered and communicated to demonstrate control of equipment and processes for a diagnostic and predictive manner.
* Understanding of process scale-up, knowledge management and technical transfer coupled with experience of trouble shooting and complex issue resolution of multiple solid dose processes.
* Understanding of facility design and associated building management systems.
* Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services.
* Working knowledge of equipment, facility and utility asset life cycle management from initial design, procurement and vendor management through to validation and operational use.
* Planning and organizational skills to project manage the operational and financial aspects of capital projects.
* Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations.

Program Management
* Individual will coordinate one of the following programs for the SDM: Safety, Cleaning, Quality, and Training.
Other duties include, but are not limited to:
* Provide Subject Matter Expertise in additional focus area: Automation, Facility Support, Process Development, Capital
* Support manufacturing and drug product development by ensuring knowledge is utilized to enable complex project delivery. To report data in an efficient and concise manner that enable appropriate utilization
* Assist in ensuring future equipment meet the technical requirements of the operation.
* Contribute to the selection and integration of new equipment and services, ensuring validation, quality requirements and the process capability of the equipment is in line with pre defined needs.
* Evaluate, manage, and report the process capability of the equipment and services employed in the operation.
* Support and develop equipment/services robustness and manage the risks and impact of failure.
* Manage minor projects which include all operational and financial aspects. Deliver these within Pfizer system and guidelines with minimal adverse impact and maximum ROI.
* Drive quality, safety and continuous improvement related activities.
* Deliver training and support to ensure efficient use and deployment of equipment.
* Provide immediate troubleshooting and manufacturing support during manufacturing operations.

Qualifications
Education and Experience:
Bachelor or Master's degree in Mechanical Engineering, Bio-Engineering, Biomedical Engineering, or Chemical Engineering. With 5+ years of pharmaceutical industry experience will be considered.

Technical Skills:
* Experience of simple and complex solid dosage forms of clinical drug product process development and manufacturing with a working knowledge of equipment qualification. Detailed process development and formulation knowledge.
* A detailed knowledge of GMP and management of quality through quality systems.
* Experience of Safe Systems of Work and risk assessment tools used in both Quality & Safety areas and the application of these in equipment and service management.

Physical Requirements:
* Role requires a Groton site presence.
* The job requires to operate pieces of manufacturing equipment in the Groton SDM area and requires business trips for FATs as well as business meetings (may require international travel).
* Standing, walking, bending, climbing, reaching and lifting upward of 55 pounds may be required.

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy42MDM0NC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
The key purpose of this position is to influence the early candidate substrate from a drug delivery and bioperformance perspective through close collaboration with partners on the Discovery project teams and in Pharmaceutical Science. You will need to act as a resident pharmaceutical science subject matter expert to inform, educate and influence Discovery teams in finding NCEs with desirable drug delivery and performance properties. This will include assessment of in silico, in vitro and in vivo data as well as design of stage appropriate formulations for preclinical studies. An awareness of later stage development needs as well as an understanding of the disease state and biology will help to enable the definition of the required design elements.

Responsibilities
* Closely collaborate with Discovery partners to evaluate molecular attributes relevant to drug delivery and influence team strategies
* Design and develop fit for purpose preclinical formulations (traditional and enabling) to enable robust candidate selection and progression
* Assess and clearly communicate drug delivery and performance risks (using in silico, in vitro and in vivo data as well as sound scientific principles)
* Maintain an awareness of and contribute to scientific literature; actively apply new concepts as appropriate
* Conduct novel research and present significant findings via internal and external presentations or publications

Qualifications
PhD in Pharmaceutics, Chemistry, Medicinal Chemistry, Physical Chemistry or Biophysics with greater than 4 years of relevant experience.

Technical Skills Requirements:
Facility with computational chemistry tools to predict physical properties and experience in the translation of molecular properties to predict bioperformance. Modeling of oral absorption phenomena and the interpretation of in vitro/in vivo ADME data. Experience with the design of typical formulation approaches and routes of administration across multiple species.

Strong organizational, interpersonal, written and verbal communication skills. Strong scientific leadership and direction of new technology initiatives. Application of fundamental principles to solve complex problems.

Physical Position Requirements:
Candidates must have the ability to perform laboratory work. Intermittent travel to Groton, Connecticut will be necessary.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4yMDY2MC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description
The candidate will lead biology efforts focused on therapeutic approaches involving vessel wall physiology and vascular inflammatory mechanisms in heart failure. This individual will leverage their depth of knowledge and hands-on expertise in studying pathophysiological mechanisms of the vascular system particularly as it underlies cardiovascular disease. This individual will be a key contributor in the cardiovascular group and expected to advance an innovative drug discovery portfolio spanning the continuum of drug development from target identification to advancing assets into the clinic and through Phase 2. The successful candidate will thrive in a fast-paced and goal-oriented, project team environment.

Responsibilities
* Contribute to identifying and advancing innovative new therapeutics approaches for the treatment of heart failure
* Drive preclinical biology through hands on research as well as effective management and mentorship of colleagues
* Effective project leadership built on collaboration with partner lines, vendors, and external experts to impact goals
* Colleague development and supervisory responsibility
* Innovative scientist who will identify and champion novel drug discovery approaches in the vascular inflammation and heart failure spaces.
* Requires excellent written and oral communication skills

Qualifications
* PhD or MD with 4+ years of post-doctoral experience, which may include 3-5 years of industry experience
* Strong record of scientific accomplishment
* Excellent verbal and writing communication skills

Technical Skills Requirements:
Technical proficiency with in vitro and in vivo models of vascular injury, particularly including some of the following:
* Experience in models of vascular injury which may include: atherosclerosis, ischemia reperfusion, myocardial infarction, stroke, wire injury, aortic constriction, pulmonary hypertension, vasculitis, angiotensin or isoproterenol infusion
* Experience with bone marrow transplant/ immune reconstitution techniques, intravital and confocal microscopy, leukocyte trafficking assays and/or preclinical histopathology techniques is desirable
* Experience with endothelial function assessment in preclinical species preferred
* Isolation and characterization of endothelial cells, smooth muscle cells and leukocyte subsets desirable:
* FACS
* Cell isolation from target tissue (atheroma, myocardium, spleen, bone marrow

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4xNDgyOS4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Reporting to the Global Head of the Research Formulations Group in Drug Product Design (DPD), the Group Leader will lead pre candidate selection DPD activities across formulation science, solid form and drug delivery assessments for the Research Units in Cambridge, MA. The group's responsibilities will encompass all areas from Lead Selection, Lead Development, through to Candidate Selection and will strive to position the compound for accelerated early development.

Responsibilities
Starting at Lead Development, works closely with Medicinal Chemistry, Drug Metabolism, Biology and Drug Safety to ensure optimum candidate selection based on the envisioned Targeted Product Profile and indication. Ensure a clear experiment plan is in place to rapidly gain knowledge on a potential candidate to help optimize selection. Balances experimental data, with state of the art computational predictive tools to guide the medicinal chemistry.

As a member of the Research Formulation group, will contribute to the strategic direction of the group as well as ensuring that there is good alignment between candidate selection, pre-POC activities and post POC development requirements.

Provide insights into the required direction of the group by analyzing trends, future needs and feedback from key partners. Direct scientific and technology investments to address future needs and enhance our ability to predict candidate success from drug delivery and biopharmaceutics perspectives.

Works closely with Chemistry Research and Development, Analytical Research and Development and Early Development Portfolio Management Group leaders on integration of activities within Pharmaceutical Science Candidate selection project teams and ensures candidates are well positioned to accelerate into the clinic.

Contribute to portfolio prioritization across the global portfolio

Qualifications
EDUCATION AND EXPERIENCE :
* Advanced degree (PhD) or equivalent in Pharmaceutical, Chemistry or Life Sciences.
* Extensive management and technical experience in discovery support and early development.
* Successfully ran groups of similar size and complexity.

TECHNICAL AND LEADERSHIP CAPABILITIES:
* Experience in drug product design, especially in the candidate selection/Pre-POC stage of development
* Experience and awareness of drug product enabling, drug delivery technologies and computational predictive tools to help design and select high quality candidates.
* Proven track record in developing new technologies and/or computational tools to address future needs.
* Has a demonstrated ability to influence and lead in a matrix environment, and with senior leaders across the wider discovery organization
* Good at making calculated risk judgments without all the required information
* Excellent presentation skills - ability to distill, craft and present key messages in complex environment relative to the audience requirements
* Strong background in pharmaceutical sciences and good awareness of medicinal chemistry and drug absorption and metabolism
* Good interaction style with multi-disciplinary teams and associated team leaders
* Good self-awareness and seeks continuous improvement and change in both internal and external environment.
* Demonstrated ability to lead through change, ambiguity and without all the information needed
* Proven ability to develop colleagues and managing teams across different global locations.

LEADER BEHAVIORS:
* Strong focus on performance, team interaction, scientific/technical excellence and fostering open discussion and debate.
* Strong influencing and networking skills in a complex research environment with many key stakeholders
* Pace setting leadership style, driving issues to a win win resolution

PHYSICAL POSITION REQUIREMENTS:
* Frequent travelling (2-3 times a month) between Boston, MA and Groton, CT

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy4xNjQxMC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

Org Marketing Statement
A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The qualified candidate will take an active role in the development and implementation of advanced analytical measurement and data analysis techniques in support of the portfolio. The ideal candidate will have extensive knowledge of theory and application of both vibrational spectroscopy and chemometrics.

Responsibilities
* The individual will be responsible for the development of analytical concepts in support of both batch and continuous manufacturing analytics.
* To be successful, the individual would need to be conversant with both vibrational spectroscopy concepts as well as be very conversant with various chemometrics approaches.
* The individual will be part of a group that is highly focused on the use and implementation of said skills to better understand our products and processes throughout the development lifecycle. This will be balanced with an ever present desire to improve upon our capabilities and help develop cutting edge analytical and predictive capabilities.
* Experience in the pharmaceutical space would be deemed necessary to be successful in this position. The colleague should possess the ability to learn quickly and solve complex problems. Job responsibilities may include developing, designing and performing experiments related to the implementation of measurement systems to our API land Drug Product processes.
* Other factors that would be advantageous: understanding of the impact of excipient variation on product quality, API material characterization technique familiarity, understanding of the current regulatory landscape for the pharmaceutical industry, familiarity with various guidance and standards that are utilized by the pharmaceutical industry, and finally familiarity with systems control principles.
* Ideally candidate would have experience in continuous manufacturing areas for both drug product and API. Familiarity with the eventual implementation area of commercial manufacturing operations would be highly desirable.
* Team interactions are important and the colleague must be able to collaborate with and mentor peers as well as effectively interact with leaders as part of a multi-disciplinary team. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

Qualifications
EDUCATION AND EXPERIENCE::
MINIMUM/DESIRABLE:
Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Physical Chemistry, Material Science or Chemical Engineering with 0-5 years' experience required. Alternatively, a BS degree with significant (10-15) amount of experience in releavant areas would be considered. Strong oral and written communication skills are anticipated for this highly interactive position.

PHYSICAL POSITION REQUIREMENTS:
Expected no more than 10% travel.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Application URL:http://www.aplitrak.com/?adid=QWxpc29uLlR1dGx5cy44MTkzOC4zMTY3QHBmaXplci5hcGxpdHJhay5jb20

OVERALL RESPONSIBILITY
The Broad Institute stands on the leading edge of biomedical research, a field now dominated by rapid advancements in data generation technologies that present vast new opportunities-and computational challenges-for researchers. The Director of DevOps will play a key role within the Data Sciences Platform.The ideal candidate will have a proven track record of designing, building, and sustaining operations on complex, cloud-based systems.

He/She will be passionate about automation and embrace the ethos that, in the modern world, “infrastructure is code.” The ideal candidate will have built solutions that scaled rapidly to meet global needs and have had experience both working with software engineering teams and leading DevOps groups.

Characteristic Duties:
Build and lead a DevOps team within the Data Sciences Platform at Broad.Maintain and build out our infrastructure on various public clouds.Architect and evolve infrastructure, server, deployment strategies and testing to support our goal of 100% up-time and quick turnaround of deployments for the engineering organization.Continuously improve our infrastructure to be easy to deploy scalable, secure and fault-tolerant systems.

Drive the process in which our DevOps team operates and iterates/releases.Handle capacity planning, provisioning and scaling of the application infrastructureDevelop high-level design interaction diagrams, system functionality changes, data model, data flow, high-level interface specificationsHelp ensure information security best practices for Client environmentsSupport and closely engage multiple teamsTechnical Competencies:We are seeking a systems engineer with at least 10 years of experience in building cloud and virtualized solutions.

Educational credentials and certifications are secondary to demonstrable, real-life experiences and proven successes.

Systems automation:
Extensive experience with Chef and or Puppet.Systems Integration and APIs: Deep experience with architecting interfaces used on large-scale platforms to create useful, aggregate solutions.

Monitoring and logging:
Extensive experience with Splunk, Stackdriver, and or Loggly.Public Clouds: We are heavy users of both Amazon and Google. Experience with at least one of those is required.Operating Systems: The candidate should be a master of all things Linux.

Containerization:
Extensive experience with Docker and DockerHub. The ideal candidate will also have experience with container repositories and management frameworks such as Mesos and Kubernetes.Continuous Integration: Ability to own our CI environment from design through support. We use both Jenkins and Travis-CI.Scripting and Programming: The ideal candidate is a problem solver who uses computers to solve problems. You will be able to tell us your favorite scripting language and use it to solve moderately complex problems. Python, Ruby, PHP, and Bash are currently in use.

Version Control:
We use git and GitHub to manage a wide variety of codebases.
The ideal candidate has experience with and understands the importance of version management, not only for code, but also for configuration.Databases: We have a substantial Oracle and Mysql environment, and also a growing use of Mongo, Couchbase, OrientDB, Elastic and others. The ideal candidate will have some experience with SQL and NoSQL databases from a usage perspective, but will probably not get too hung up on “being a DBA.”

Non Technical Competencies:
Mentoring and Leadership:
The ideal candidate will be interested in building teams beyond themselves. This means teaching other technical people how to do what we already know how to do, so that we can get on with the business of building the future.Communication: The ideal candidate will be able not only to get technology working but also explain how it works, in both oral and written form.

Team Structure:
The ideal candidate will be familiar with Agile / Scrum. The candidate should be experienced with supporting multiple teams from ideation through implementation and technical handoff, whatever the organizational framework.

Ability to work in a multidisciplinary, collaborative environment:
- The ideal candidate will enjoy interfacing with a number of teams outside of the Data Sciences Platform and can thrive in a multidisciplinary environment
- Energy and Enthusiasm

Qualifications
- Bachelor’s degree in computer science or other technical discipline
- Minimum of 10 years of directly related professional experience
- Demonstrated ability to manage the operations and infrastructure on public clouds
- Expertise in one or more scripting language (Perl, Python, Ruby, PHP), as well as DevOps automation and continuous integration frameworks.Extensive knowledge of RDBMS technologies including Oracle and MySQLFamiliarity with delivering IT services in an academic or scientific research organization highly desired
- Excellent leadership and exceptional verbal and written communication skills
- Must be able to communicate effectively with technical and non-technical audiences
- Must be a self-starter with the ability to work independently and in a team environment
- Excellent time management and organizational skills
- The Broad Institute will not offer visa sponsorship for this opportunity.

EOE/Minorities/Females/Protected Veterans/Disabilities

To apply for this position, please CLICK HERE

OBJECTIVES: 

The Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda pipeline compounds. Leads a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compound in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences TGRD and TPC senior leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of TGRD to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES: 

• Clinical Development team participation and leadership
  • Leads Global (US/EU/Japan) Development Team managing both the US/EU Development Team and the Japan Development Team for a given product. May lead the US/EU Development Teams and represents Clinical Science on the Global (US/EU/Japan) Development Team to ensure that activities are aligned with the global strategy. 
  • Establishes and drives Development Team strategy and deliverables producing the Development Strategy, Clinical Development Plan and Clinical Protocols.  Recommends scope, complexity and size, and influence the budget of all aspects of a program.  Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
  • Responsible for high impact global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.  A significant error in judgment may result in loss of approvability and commercial viability of a product.
• Synopsis / Protocol Development, Study Execution, & Study Interpretation
  • Drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies.  Serves as an advisor to other clinical scientists involved in these activities, and is accountable for the successful design and interpretation of clinical studies.  Presents study conclusions to Management and determine how individual study results impact the overall compound strategy.
  • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Trial Medical Monitoring
  • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.  Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance.  Oversees non-medical clinical scientists with respect to assessment of these issues.
  • Makes final decisions regarding study conduct related to scientific integrity.
• External Interactions
  • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas.  These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.  Lead roles will also be taken on the incorporation of advice / recommendations received into the design of clinical studies / programs as appropriate; accountable to senior leadership for the successful completion of related objectives.
• Due Diligence, Business Development and Alliance Projects
  • Responsible for identification and evaluation of potential business development opportunities, conduct due diligence evaluations, and development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities.  Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams in conjunction with TPNA/TPEU/TPC. 
  • Serves as clinical contact point for ongoing alliance projects and interface with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
• Leadership, Task Force Participation, Upper Management Accountability
  • Interacts directly with research division based on pertinent clinical and development expertise and with TPNA/TPEU to provide knowledge / understanding of market environment in line with status as TGRD scientific content matter expert for assigned compounds.  May represent clinical science on multidisciplinary task forces across divisions (e.g. TGRD and TPNA/TPEU/TPC).   Lead TGRD internal teams and may lead global cross-functional teams, as appropriate.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: 

• MD or internationally recognized equivalent plus 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• NDA/MAA/Submission experience preferred.
• Management experience

Skills

• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities

Knowledge

• Therapeutic area knowledge relevant to mechanism of action
•  Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic area

TRAVEL REQUIREMENTS:

• Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
• Requires approximately 15 - 25% travel.

Vericel is seeking a talented Process/Equipment Engineer to join the Cambridge team and work in close collaboration with facilities and operations. The right candidate will be an enthusiastic engineering professional with experience in the highly regulated world of cGMP Manufacturing. The Process and Facility Support Engineer will be involved in cross-functional planning and execution of projects pertaining to facilities, equipment, process changes, packaging design for biologic products, and validation. The ideal candidate will have working experience within an FDA regulated environment and should be familiar with SOPs, CAPAs, Deviations, Change Control Procedures and Validation.  The candidate should be comfortable working collaboratively with team members from multiple functions and must be able to shift priorities as project needs change. 

Duties:

·Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning and documentation of new systems and the ongoing support of existing systems.

·Provide cost estimates for new systems and equipment, and modifications or upgrades to existing systems

·Lead design reviews, construction progress and installation support.

·Perform engineering startup, factory acceptance testing, commissioning, documentation, validation support and operator training.

·Provide day to day engineering support for process equipment such as Biosafety Cabinets, Freezers, Incubators, Autoclaves, Heat Sealers, etc

·Provide day to day engineering support for equipment such as RODI Water Systems, Vacuum Pumps, Air Compressors, HEPA Filtration, HVAC, etc

·Understand all GMP facility systems and engineering standards, create and edit SOPs and deviation reports.

·Develop responses to CAPAs, Deviations, and Change Controls utilizing the Trackwise Quality System

·Create Engineering Reports and Protocols

·Provide support for BMS controls, industrial process instrumentation and PLC control

·Develop and maintain corporate engineering specifications, drawings and standards

Requirements:

·Bachelor's degree in Mechanical, Electrical or Biomedical Engineering

·Minimum 3 years experience working in a GMP environment (or similar experience)

·Experience with installing, servicing and maintaining equipment cleanroom environments

·Proficient in CAD software, preferably AutoCAD

·Able and willing to work cross-functionally with members from multiple teams and at different levels

·Experience with MS Office: Outlook, Word, Excel, PowerPoint

·Experience in writing and editing Engineering Reports and Protocols

·Experience with Trackwise Quality System is preferred but not required

All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity Employer.

Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE™ (irinotecan liposome injection), was approved by the U.S. FDA on October 22, 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.

The Senior Clinical Data Manager/Associate Director of Clinical Data Management (CDM) is responsible for maintaining Clinical Data Management operations at the study and functional area level. The successful candidate has a history of networking with internal teams and external partners to ensure clinical data are of high quality, delivered within project timelines, and on budget. The position reports to the Director of Clinical Data Management.

Responsibilities:

• Clinical Study Data Management Execution
  • Lead the development of CRFs
  • Oversee the build and validation of data capture systems (EDC, IWRS)
  • Develop the data management plan and other study-specific documentation
  • Implement metrics to monitor status of data entry and quality
  • Coordinate data reviews, coding reviews, external data reconciliation, and ensure resolution of data issues
  • Manage data transfers and database release activities
• Team data management leadership
  • Communicate and coordinate data management activities with project teams
  • Monitor workflows and track progress for completion of tasks
• External vendor management
  • Identify vendor(s) for outsourcing data management activities
  • Review contracts, as appropriate
  • Represent Merrimack in interactions with external vendors
  • Lead in-house project level data management activities on assigned studies
  • Oversee CRO work on data management activities on assigned outsourced studies
  • Work with all external vendors to establish data transfer agreements and to reconcile data to ensure broad data consistency
• Functional area leadership
  • Develop, implement and maintain data management standards
  • Identify resource needs and recruit/hire personnel, as needed
  • Provide mentoring, training and development for data management staff
  • Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements
  • Develop and maintain standard operating procedures (SOPs) for CDM
  • Train peers on clinical data management activities and procedures
  • Serve as CDM subject matter expert on regulatory audits

Requirements:

• B.S. in a relevant field with 7+ years of experience in clinical data management. Experience in managing reports preferred
• Leadership skills and experience; assist with training and development of less experienced personnel
• Good working knowledge of medical terminology; and the clinical data management and the clinical trial process
• Familiarity with regulatory requirements for data management and the regulatory submission process
• Proficiency on SOP development, implementation, and adherence
• Proficiency on the design and validation of data collection instruments; data standardization, theory, design, collection, and review for implementation of standards and technologies across the organization
• Demonstrated project management and vendor oversight skills
• Good working knowledge of coding dictionaries: MedDRA and WHO-DD dictionary
• Experience with electronic data capture (EDC) systems Perceptive Datalabs, Medidata/RAVE, etc.
• Proficiency with the development of CRF/eCRF for clinical trials and its impact into database design/development
• Basic understanding on identifying and implementing new data standards, technologies, and systems
• Oncology experience with understanding of RECIST guidelines preferred
• Demonstrated initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously
• Experience using SAS/EG to facilitate data review preferred
• Competence with MS Office programs, particularly Word, Excel and PowerPoint
• Self-motivated, collaborative team member
• Ability to communicate effectively with senior management as well as with peers
• Effective written and verbal communication skills
• Passion for fighting cancer

All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status.

Do you consider yourself organized, meticulous, and enthusiastic? Our client is a dynamic biotechnology company in Cambridge, MA with a passion for developing new drugs in areas of high unmet need and they are looking for a Quality Assurance Specialist.  This position will assist the QA Team in quality system compliance and product quality.  You will also be maintaining systems and standards to ensure compliance with Gxp and International regulations.

• Some additional components to the opportunity:
• Support Quality, Manufacturing and Operations in a Documentation Systems capacity under minimal supervision.
• Apply technical proficiency and attention to detail in troubleshooting and management of the Quality documentation and training systems. 
• Coordinates implementation and maintenance of the controlled document management system companywide.
• Proactively identifies opportunities for process improvement in the document control and training systems and works cross functionally to implement, as appropriate.
• Reviews as document control all Policies, SOPs, Work Instructions, Forms, and Templates.
• Facilitates training documentation and processes.
• Interacts with internal customers and functional groups at various management levels to provide customer service.
• Assists in coordinating activities in support of audits and/or regulatory inspections, as required.
• Participates as a representative of Quality on internal cross-functional project driven sub-teams, as required.
• Assists all departments in the implementation, training and maintenance of the controlled document management system.
• Manages the full life cycle of SOPs, Work Instructions, Attachments, and Templates within the controlled document system.
• Performs other duties as assigned.

 REQUIREMENTS

• B.S. in a scientific or allied health field (or equivalent degree) and at least 3 years of relevant GMP Quality Documentation experience

• Experience working with electronic Document Management Systems (eDMS) a plus.

 About StratAcuity

Whether you are seeking a career change or simply interested to become part of our network, you will appreciate the ethics guiding each StratAcuity team member. We build lasting relationships with exceptional scientists and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a StratAcuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

CHEMISTRY IS EVERYTHING™

Editas Medicine is a transformative genome editing company with a mission to translate its genome editing technology into a novel class of human therapeutics that enable precise and corrective molecular modification to treat the underlying cause of a broad range of diseases at the genetic level. 

This exciting opportunity will be responsible for helping to develop and assess tools to be used for the treatment of rare genetic diseases in an entrepreneurial, fast-paced team environment.  In this role, you will be using your experience in next generation sequencing technologies (library prep, quality control, sequencing hardware) and targeted nucleic acid detection technologies (qPCR, droplet based PCR) to help develop techniques and processes for the successful translation of this technology into the clinic.  Experience on clinical materials, genomic DNA prep and developing new assays would be a plus. The position requires flexibility, creativity, and the ability to work effectively in a multi-disciplinary team, as well as excellent written and verbal communication skills, and a capacity for creativity and innovation to achieve company goals.

Minimum Qualifications:

• B.S./M.S. in cell or molecular biology with at least 1-3 years of relevant experience (ideally industry)
• Expertise in sequencing and molecular biology, with hands-on skills on DNA/RNA extraction, library construction, automation, quality control, ddPCR and qPCR is required; hands-on experience with Next Generation Sequencing instrumentation is essential.
• Experience with protocol development, optimization and documentation is required
• Experience interfacing with bioinformatics scientists to quality control and interpret sequencing data is a plus
• Excellent attention to detail, ability to work in a team-oriented, multidisciplinary environment

Provide a safe, controlled work environment in all areas of responsibility. Be aware of the site safety objectives and make sure they are communicated and understood by all staff.

Responsibilities include staffing, training and retaining energized, motivated, team

oriented staff. Will need to stress and carry forward operator training, education

and advancement. Utilize work staff in an efficient manner through cross training

and flexible resource planning.

Work with Quality groups to ensure cGMP compliance in all areas of

manufacturing. Endeavor to have all batch records real time reviewed in support of

on time lot release. Accept accountability for variance and deviation generation

rates and ensure their timely closure.

Work with Tech Transfer teams to bring on and maintain customers' processes.

Collaborate with the MTS group to bring  process improvements to routine

manufacturing.

Participate in annual budgeting and be responsible for meeting financial goals and

objectives. Attempt to identify and contribute to real operational improvements and

philosophy.

Will be held responsible for meeting production schedules yield targets. Will be

challenged to help create a continuously improving manufacturing operation that

excels both technically and operationally. Help develop and manage information

systems to monitor the efficiency and success of the operation.

Responsible for coordinating required facility improvement projects with

production requirements.

Qualifications

Solid staff management experience and proven ability to manage budgets. Ability to work inter-departmentally and potentially with customers.  Excellent leadership skills a must. 

BS Degree in appropriate sceince, MS Preferred

Manufacturing setting preferable with both Fermentation and Purification experience

10-15 Years of supervisory experience

5-8 Years of experience in team based management

Budgeting

M/F/Disability/Veterans

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary:
The Director, US Sales Training for ARIAD will be a home office based position in Cambridge, MA, reporting to the SR. Director, US Commercial Operations. This person will work closely with the US Commercial Leadership Team, to include National Sales Director and US Brand Directors. They will have a field based Training Manager reporting to them. The successful candidate would consistently lead efforts to execute content related to CML and ALK mediated NSCLC. Primary responsibility will be in leading training efforts for the US Sales team.

Job Responsibilities:

• Effectively execute projects within timelines and budgets, working with both internal resources and external vendors/consultants.
• Develops specific curriculum for onboarding sales professionals/managers and continuous learning solutions for tenured representatives/managers executed via a blended learning approach.
• Serves as a key commercial leadership team member to provide training and development expertise and/or provide process facilitation on key projects. 
• Ensures all sales employees receive consistent, ongoing training through a blended learning approach (live training, e-learning, and self-guided learning).
• Ensures training is effectively designed and executed to meet the needs of the Brands (tactics, strategies, new launches, product knowledge, and competitive knowledge.)
• Ensures implementation of selling skills training and corresponding management coaching.
• Remains current on the latest training and development practices (via research, benchmarking, and industry knowledge) and share this expertise with others to ensure ARIAD sales training initiatives are on leading edge.
• Represent/navigate training initiatives as necessary thru medical/legal/regulatory approval process.
• Work cross functionally with marketing, medical affairs, clinical, etc. to better understand market factors and develop new and revise subsequent training initiatives as needed.
• Measure outcomes of training initiatives and create plans for continuous improvement

Job Qualifications:

• Minimum of a Bachelor's degree (or equivalent) and minimum of 10 years of industry experience.  A Master's degree (or equivalent) is preferred. However, a combination of experience and/or education will be taken into consideration.  
• Translates vision into plans and leads their execution. Impact is on mid- to long-term goals.
• Accountable for the budgeting process for training department.  
• Minimum of 5 years sales experience in the biopharmaceutical industry
• Proven track record for delivering strong, consistent results during sales experience
• Sales training experience in the biopharmaceutical industry preferred
• Experience in specialty markets, with hematology/oncology or orphan drug experience preferred
• Ability to work effectively in cross-functional environment as well as independently on a consistent basis
• Ability to develop strong, professional relationships
• B.A. /B.S. in business or scientific field preferred
• Approximately 25% US travel

ARIAD Pharmaceuticals, Inc. provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=608&company_id=16419&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.