The Corporate QA Training group oversees the company's GxP training program and works to ensure that employee training needs are identified and met. The group manages and administers the company's validated electronic Learning Management System (LMS), develops &/or sources a range of compliance-related training, and works to ensure that employee training records are well managed and inspection ready.

The Training Specialist Coverage Contractor will oversee training assignments in the LMS across multiple departments assisting Training Sponsors and line managers directly. Responsibilities also include contributions to the on-going operation and improvement of the QA Training program.

Primary Duties and Responsibilities:

Centralized LMS Administration
- Acts as primary contact and support to assigned departments for LMS and training related issues. Fields questions and issues from functional staff.
- Provides support to other LMS administrators in all areas of the company and provides coverage during vacations or leaves.
- Works collaboratively to identify plans for resolving issues and identifying steps to prevent potential problems
- Provides reports and support as needed for corporate quality audit / inspection activities.

Functional and Subject Area LMS Administration
- Creates and manages course items (sets prerequisites, initial & re-training periods, substitutes);
- Creates and manage online exam objects and content;
- Creates and manage subject-area curricula
- Coordinates training assignment for employees in assigned areas
- Works with each line manager to develop/revise position-specific training requirements.
- Assigns training to employees and ensures requirements are updated;
- Identify training that needs to be delivered across functions;
- Documents changes made to learning plans;
- Identifies new training opportunities/requirements
- Runs reports upon request and sends monthly learning needs to managers.

Working hours: 8:30-5:30

Administration of Documentation/Training Gateway Link
--Reviews information sheets and training plans and works with document authors to ensure information is adequate and complete. Provides final approval for document to enter LMS and for pending release from EDCS.
--Facilitates the execution of all training plans in the LMS
--Assist QAT members working with training sponsors and line managers to develop training curricula in the LMS.
--Partner with QA Documentation team
Secondary Responsibilities.
--Participates in and continuous improvement projects such as training related computer system validation and change controls, updating and writing SOPs and developing new training business processes.

Basic Qualifications:
--Bachelors degree with 2 or more years experience in teaching, training or educational activities (Associates Degree with 5 years of experience)
--2 or more years experience working in a pharmaceutical company
--Prior experience using validated training management systems (such as Plateau, Sum Total, Blackboard, ISOTrain) with clear potential for full proficiency as an LMS administrator
--Strong communication skills
--Strong analytical and problem solving ability
--Collaboration skills and a strong customer service mindset
--Proactive, self-directed working style

To Apply please visit: https://us.randstad.com/content/findjobs/application/job-application.xml?jobId=147868&__version=5

The Service Desk Business Analyst is responsible for driving improvements in Service Desk operations through the documentation of work practices, knowledge management, and analyzing service trends. Reporting to the Service Desk Manager, the Service Desk Business Analyst will play a key role in improving the quality and efficiency of Millennium's Service Desk function. The Analyst will monitor data trends in an effort to identify opportunities for improvement. The Analyst will also work closely with the rest of the service desk team to refine these opportunities, outline options for approaching these improvements, then implementing the improvements. The successful outcome of these initiatives will be improved customer satisfaction with the end user community and IT colleagues as well as driving down the cost for support.

-Document, review, and maintain service desk work practices to ensure that the team is working efficiently and consistently.
-Author knowledge articles to outline the best resolution for cases, authoring documentation in support of transitioning new services to the desk, and training the team on new or reoccurring incidents.
-Review trends in incidents to identify potential changes that could be made in order to drive down incident rates, monitor adherence to work practices, and identify opportunities for improvement.
-Lead projects to implement changes to drive down incident rates and increase efficiency.
-Identify and implement opportunities for improved end user self service.
-Design and run ad hoc reports in order to answer specific business questions.
-Prepare presentations and reports for providing transparency within the service desk as well as key stakeholders (e.g. quarterly service desk operating reviews).

Working hours: 8:30-5:30

Qualifications:
-Must have 3-5 years experience in business analysis or comparable experience, education, and training.
-Must have strong analytical and quantitative skills.
-Previous project management experience highly desired.
-An understanding of basic statistical principles is highly desired.
-Advanced Excel skills highly desired.
-Should have strong writing and documentation skills.

A career with Randstad at Millennium, where "We Aspire to Cure Cancer", comes with something no other partnership can offer: a community of people, both contract and permanent, with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world-one patient at a time. The casual but focused environment fosters a free exchange of ideas, encourages collaborative research and sparks discovery.

Through utilizing a dedicated, on-site team, Millennium works in partnership with Randstad in order to fill Millennium's contract workforce needs. Randstad is fully integrated with Millennium's Human Resources department and works collaboratively to develop policies and practices that reflect Millennium's overall mission and values. As a contractor for Randstad you are eligible for health benefits, 401k, supplemental benefits, on-line education courses and more.

To Apply please visit: https://us.randstad.com/content/findjobs/application/job-application.xml?jobId=147737&__version=8

https://home.eease.adp.com/recruit/?id=3669231

Infinity is an innovative drug discovery and development company seeking to discover, develop, and deliver to patient’s best-in-class medicines for difficult-to-treat diseases. Infinity combines proven scientific expertise with a passion for developing novel small molecule drugs that target emerging disease pathways. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences. Through a series of strategic alliances, Infinity is in a position to independently fund the development and commercialization of its drug candidates.

Responsibilities:

• Provide support to Data Management, Statistics and Clinical Operations functions including:
• Integrate data from a variety of enterprise systems including Electronic Data Capture (EDC), external data sources (e.g., Interactive Voice Response (IVRS), ECG, laboratory data), Clinical Trial Management Systems (CTMS), Data Warehouses and SharePoint
• Management of validated systems and compliance with associated SOPs and best practices (e.g., system validation support, change control, etc.)
• Mapping clinical data into an internal data warehouse using data standards(e.g., SDTM)
• Develop and deploy data visualizations and reports for end users
• Create and maintain user documentation and training materials

Requirements

• BS or equivalent with at least 3 years of professional experience with an understanding of clinical trials and database programming
• Working knowledge of relational databases and data structures
• Programming experience with SQL required, experience with other languages desirable (e.g. C Sharp, Python, Java etc)
• Experience with Business Intelligence software such as Spotfire, Business Objects or similar and reporting software
• Desire to learn and advance career in biotechnology industry or related field
• Highly organized, proactive and self-motivated
• Good written and verbal communication skills
• Strong sense of customer service and able to follow-up on multiple issues simultaneously
• Demonstrated ability to work as part of a team
• CDISC (SDTM) experience

Additional skills appreciated, but not required:

• Knowledge of 21 CFR Part 11
• Data warehousing experience
• Knowledge of Software Development Life Cycle

To apply please visit our website: http://www.infi.com/careers-opportunities.asp

• Identify and evaluate the risks and thereby contribute to define the  safety strategy,
• provide timely and accurate medical evaluation of individual and aggregated safety data from pre- and post-authorization sources, i.e. medical assessment for ICSRs, SUSARs
• Ensure correct MedDRA coding of adverse events from assigned case reports.
• Prepare PSURs/PBRERs, medical assessment for other aggregated safety reports (e.g. EU ASR, 6-monthly SUSAR report).
• Perform signal detection from the internal safety database and FDA´s AERS database, and literature reports.
• Ensure adequate medical input in case of safety crisis/medical alert situations.
• Provide safety input to clinical trial activities as appropriate
• Write safety sections of trial related documents (e.g. protocol, informed consent, case report form, SAE form, monitoring plan, Interactive Voice Response System specifications, SAE reconciliation plan, study report) and coordinate review of/contribution to these documents by relevant GDS functions where applicable. Write the program specific/trial-specific Drug Safety Manual.
• Review documents related to outsourcing of trials (e.g. CRO contracts, Request For Proposals and Service Agreements with CROs), where applicable
• Provide contribution to periodic safety reports
• Contribute to set up Clinical Trial Safety Management processes, as appropriate
• Maintain an appropriate level of knowledge about the product and the therapeutic area;
• May be required to represent GDS on cross-functional teams for the product, including eg the GPT, CTT, Submission Team, and any Alert Action Teams, ensuring that all negotiated and agreed deliverables and deadlines for these teams are met
• Provide product training to GDS colleagues, and safety training to non-safety colleagues, as required

STRATEGIC IMPACT

• may act as a member of a GPT or Life cycle management team as appropriate
• may provide a single initial point of contact within GDS for all aspects relating to the safety of a product
• to represent TA Group in IRMA teams when requested

• Internal GDSM groups and GDS groups (Global Drug Safety Operations, Global Drug Safety Science,  Global Drug Safety Compliance & Standards ,Global Drug Safety Regions, EU QPPV)
• GCDUs, GRA, GCO, Medical Information and Communication, MASC, Corporate Communication, GPU, Business Units.
• Global Product Teams, Clinical Development Teams, Submission Teams

• Regulatory Agencies, Consulting experts, members of IDMCs/DSMBs and co-development partners as appropriate
• Must be prepared to describe and demonstrate these job attributes to regulatory authority inspectors during pharmacovigilance or other regulatory inspections

Required professional experience and necessary training

• MD with clinical experience or Master of Science/Ph D with work experience in pharmacovigilance area
• Fluent in written and spoken English

Necessary professional experience

• Industry experience (minimum 2-3 years), preferably including both clinical development and pharmacovigilance experience (including medical safety evaluation and safety based decision making)
• Excellent knowledge of product development process and experience of cross-functional team work.
• First hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good understanding of the therapeutic area
• Professional experience in an international environment

Specifies personal skills and competencies required

• Strong team player and excellent networking skills
• Solution and results orientated
• Willing to cope with resistance and problems; demonstrated ability to work under pressure and achieving strict timeline targets
• Excellent verbal and written communication skills (in English language)

ADA REQUIREMENTS

• Normal and routine office duties
• Position requires both domestic and international travel up to XX% of time
• Overtime may be required

Our client is seeking a Research Associate experienced with analytical instrumentation including HPLC and GC along with computer systems and software.  Responsibilities include the development and execution of bioanalytical methods to support the analysis and characterization of a protein biologic.  The ideal candidate must have the ability to work independently in the design, execution and interpretation of experimental protocols and the drafting of analysis reports.  This position requires a BS/MS in Biochemistry or related discipline with a minimum of two years directly relevant industry experience.  Experience with variety of protein analytical techniques including chromatographic, electrophoresis, immunological and enzymatic assays as well as familiarity with cGMP analytical requirements would be a plus.

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.

StratAcuity, CHEMISTRY IS EVERYTHING.

PerkinElmer Informatics division is a leading supplier of discovery, collaboration, and knowledge enterprise solutions, desktop and mobile software, scientific databases, and consulting services to the pharmaceutical, biotechnology, and chemical industries.  Our software enables customers to create, analyze and communicate chemical, biological, and scientific information more effectively.

 Our Professional Services Organization is looking for a hands-on resource with strong domain knowledge in research informatics to lead requirements analysis, product installation and configuration, and provide training.

 Responsibilities

• Become a trusted advisor to customers
• Successfully execute analytics projects for customers
• Identify customer needs, propose solutions, and assist in business development activities
• Improve processes, ensure compliance & drive improvements, as needed
• Create, maintain and assume accountability for a culture of high customer service
• Successfully link technology to customer business problems and achieve desired outcomes
• Advise customers on developing Business Intelligence systems that provide competitive value
• Design and implement systems that display and manage data and information to support scientific and business decisions across R&D
• Define new project opportunities, ensuring that project scope and effort estimates match customer requirements

Requirements

• Bachelor’s or Master’s Degree in Life Science or Technical field
• 2-5 years of relevant experience in projects involving enterprise analytics systems, ideally from inception through completion
• Customer facing experience in deploying COTS enterprise systems
• Experience deploying TIBCO Spotfire® or similar visual analytics enterprise software
• Strong knowledge of XML and scripting languages
• Strong database, data architecture, systems design, .NET, C# skills
• Advanced statistics knowledge desired and experience with tools such as SAS, S+, and R
• Ability to travel and work at customer sites required
• Strong verbal and written communication skills
• Good requirements analysis & documentation experience
• Problem solving and analytical capabilities; ability to deal with and resolve conflicts
• Planning, prioritizing and reporting
• Attention to detail and a concern for quality

Our client is seeking an experienced Training Leader for their GMP biopharmaceutical campus. This person will lead 2-3 Managers and a broader team of technical trainers and instructional designers to further develop and implement a new competency-based training plan. This a high profile role with significant interaction with site leadership and as well as Global Department Heads.

Responsibilities include but are not limited to;

• Leading the design, development, implementation and facilitation of CGMP training.
• Ensuring compliance with all regulations including appropriate documentation, qualification of trainers, and development of approved training material.
• Work with other site training managers and global department to assure standardized training delivery mechanisms and implementation of global best practices.
• Develop measurement criteria to assess effectiveness of training and report compliance metrics to site and Global Department Heads.

A formal description can be supplied for interested candidates.

Qualified candidates will have a BS degree or higher and 8+ years of experience, with at least 3+ years leading other training professionals. Must have demonstrated GMP experience (in biopharmaceuticals or medical device) and experience with ELMS systems and e-learning content design. Preference given to those with a Master's degree in instructional design or related field.

Resumes to nuno@hireminds.com to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Our client is opening several roles in their Operational Excellence group in a GMP biologics production facility. This group will be focused on taking a proactive approach to Operational Excellence and Continuous Process Improvement. If you have experience with leading 5S, Kaizen Improvement, Value Stream Analysis, and other team-based workshops and are open to considering a new opportunity, please connect with me to learn more.

A formal description can be supplied for interested candidates.

Qualified candidates will have a BS degree or higher in a related discipline and experience with Lean/Six Sigma or other Continuous Improvement Methods. The Hiring Manager has the flexibility to consider profiles ranging from junior to senior individual contributors. Must have strong communication skills.

Resumes to nuno@hireminds.com to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.

Full time perm openings available at top biopharma clients in Boston, Cambridge, and New England. This is a leadership opportunity within an international biopharmaceutical company at their site in the suburbs of Boston. Reporting into the Director of Engineering, you will be responsible for driving the clean utilities program and managing a team of Engineers, contract staff, and external resources assigned responsibility for system ownership and change control execution.

Responsibilities include but are not limited to;

• Design, installation, maintenance, and continuous improvement to all critical utility systems supporting cell culture, purification, and site operations. Utility systems include WFI, Clean Steam, RO/DI water systems, Compressed Gases, HVAC, and Wastewater.
• Deliver maximum equipment uptime and safe operation of utility systems.
• Design, specification, commissioning, and startup for capital projects and ongoing optimization activities.
• Lead risk analyses/investigations and manage all change controls for critical utilities.
• Establishment and sharing of best practices with other sites.

A formal description can be supplied for interested candidates.

Qualified candidates will have a BS degree or higher in relevant Engineering discipline and 10+ years of experience in a GMP utilities/facilities environment, with 3+ years of experience managing Engineers. Must have experience with cGMPs, Commissioning and Qualification principles, Clean Room Standards, and Biologics manufacturing. Preference given to those with Grade 5-I Massachusetts Waste Water Treatment License.

Relocation assistance is available to qualified candidates. Resumes to nuno@hireminds.com to be considered. All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients. 

Associate Director/Director, Search and Evaluation

EnVivo Pharmaceuticals, Boston

EnVivo is developing its broad pipeline of diverse programs with a focus on leveraging novel mechanisms of action to treat CNS diseases like schizophrenia and Alzheimer’s disease in new ways and from multiple angles. Our approach is multi-target and multi-program by design - with no therapies currently available to treat the underlying causes and mechanisms of many CNS diseases, the scientific expertise and drug discovery ability to pursue a variety of disease targets is key. EnVivo has created a diverse pipeline of promising drug programs with mechanisms that could alter the progression of disease or provide sustained improvement in function to patients with serious CNS disorders, including Alzheimer’s disease, schizophrenia and others.

We are well financed and strongly positioned to develop and commercialize our own programs. Our primary goal is to rapidly and effectively translate our promising research and development programs into safe and effective CNS therapies for patients. As we also work to build an integrated drug company, our strategy is to retain a meaningful lead role in development and commercialization of our programs in certain indications and geographies, while also seeking to strategically partner our programs in order to fully realize the promise and potential of our pipeline.

The successful candidate will assume primary responsibility for identifying and evaluating opportunities for drug development program acquisition or in-licensing and will report into The Chief Business Officer.  Primary emphasis would be on Phase 2 and later CNS programs, with secondary emphasis on earlier stage CNS-related technology. 

Responsibilities include:

• Work with the management team to define and articulate technology search criteria
• Establish and develop worldwide contacts with potential program sources
• Establish EnVivo in-licensing presence at structured licensing/partnering events
• Become facile with relevant CNS clinical landscape: targets, mechanisms, competitive dynamics
• Make independent initial judgments regarding triage of candidate programs and decide what to bring forward for internal discussion
• Lead informal cross-functional  teams to perform relevant expert analysis, due diligence and discussion
• Champion specific licensing prospects within EnVivo
• Contribute to competitive intelligence gathering and synthesis activities in database (output is regular updates and reports)

Requirements include:

• MD or PhD in neuroscience or related discipline with a minimum of 8 years of experience in biotech and/or large pharmaceutical industry
• Breadth of experience to interpret wide range of preclinical and clinical data across multiple indications
• Excellent communication skills 
• Scientific/medical judgment to make sound initial triage decisions
• Experience in technology search and evaluation preferred
• Experience working in multifunctional teams
• Ability and eagerness to travel extensively and independently
• Business development experience per se helpful but not required

Research Associate (Job code: RAC 003)

Diagnostics For All (DFA) is an exciting non-profit organization focused on improving global health by creating and commercializing very low cost, easy-to-use, point-of-care medical diagnostic devices for underserved populations in the developing world.  Conveniently located in Cambridge, Massachusetts, we are creating a new generation of diagnostic devices using elegantly simple paper-microfluidics technology originally developed in the lab of Professor George Whitesides at Harvard University. DFA has received several grants to develop this technology from varied sources including the Bill & Melinda Gates Foundation, USAID, and DARPA.  Please learn more at www.dfa.org.

Position Summary

DFA is seeking a creative and highly motivated scientist to fill a position at the Research Associate level in our paper microfluidics assay development program. 

We are searching for a candidate with strong technical skills and a passion for solving problems affecting those living in low-resource settings. The candidate must have a B.S. or M.S. degree in biochemistry, immunology, chemistry, biomedical sciences, or a related field.  The ability to work independently with initiative and creativity is necessary.  While not required, experience working or traveling abroad, especially in developing countries, and willingness to occasionally travel internationally when required are valued.

The successful candidate will have the opportunity to join a small, passionate team developing a novel technology with the potential to positively impact millions of people in the poorest areas around the world.

If you are interested in an exciting opportunity to change the way health care is delivered in much of the world, contact us at careers@dfa.org.  Please reference RAC-003 in the subject line.

Basic Qualifications

Bachelors degree in relevant area (see above)
Prior laboratory experience in protein characterization, enzyme kinetics and immunoassays.

Preferred Qualifications

Masters degree in relevant area (see above)
Experience working/traveling in developing countries
Experience with biological samples (e.g., blood or plasma)
Experience with microfluidics or other device engineering
Experience with computer design and imaging software (e.g. Adobe Illustrator, Photoshop)

In this newly created position the Manager/Sr. Manager, Learning & Development will have the unique opportunity to help build a Training organization, to develop and deliver related programs to the Sales and Medical Affairs’ teams, and to ensure proficiency in both knowledge and execution. This individual will play a key role in preparing the field teams and other internal departments for the potential launch of the company’s first commercialized product and in establishing and sustaining field success. Program development will be founded around disease state, product and marketplace knowledge, the treatment landscape, the healthcare environment, corporate compliance, skill set development, and business acumen while promoting overall sales force effectiveness.

In addition this position will support corporate training initiatives to ensure compliance with OIG guidelines. The incumbent will aid in the creation and facilitation of all areas and phases of training that address on-going field needs at Managers’, Plan of Action and Launch Training meetings and provide continuous support via distance learning initiatives and other appropriate means. Collaboration with Sales, Marketing, Reimbursement, Sales Operations, Legal, HR, Regulatory, Medical, and Co-development Partners is essential for success within this role.

Responsibilities

• In conjunction with the Sr. Director, Learning & Development, design and implement training materials and programs that support the launch plans of the US Sales and Marketing teams to ensure launch readiness
• Aid in the development of departmental strategies and their associated tactics
• Lead and coordinate new hire training programs for the Commercial Operations and Medical Affairs’ Teams
• Promote continuous learning through the creation and execution of product, marketplace, business, compliance and skill-based training for sales specialists in collaboration with internal stakeholders, partners and external vendors
• Establish goals and learning objectives with the purpose of designing effective curricula, utilizing the principles of adult learning
• Analyze the marketplace, conduct gap assessments and implement solutions that address immediate, mid- and long-term business needs
• Identify and leverage company resources, tools and programs to assist in the development of training tools
• Incorporate performance metrics that measure program impact and effectiveness
• Oversee vendor selection and management to support training efforts as needed
• Include all required regulatory and legal compliance programs into training endeavors as appropriate
• Collaborate with AVEO’s commercial corporate partner to achieve consistent and compelling materials and programs
• Partner with Regional Business Managers and work with their Sales Specialists in the field to provide coaching and feedback and assist in driving sales
• Develop and manage the training portal, meant to support field effectiveness and serve as the central repository for departmental offerings
• Leverage technology, such as the iPad, LMS, and training portal, to promote cost effective remote training opportunities
• Engage in cross functional training with other sectors, such as Marketing, Clinical and Corporate
• Perform additional responsibilities and participate in special projects as assigned
• Actively pursue continued education for the purposes of self-development and the ability to ensure timely offerings to the field

Qualifications

• Requires a minimum of 5 years oncology experience, with at least 2 years in a Sales Training or related role
• Prior experience launching new product(s) is a plus
• Innovative thinker skilled at leading a project from conceptualization to roll-out
• Ability to design and develop training programs and undertakings with limited vendor support
• Demonstrated success in managing numerous projects simultaneously
• Established at forging successful relationships across multiple functional areas and levels within and across organizations
• Strong influencing and negotiating skills with an ability to generate support for the training agenda
• Experienced at leveraging new technologies to enhance the effectiveness and efficiency of the deliverable
• Exhibits excellent verbal, written and facilitation skills
• Up to 25% travel required
• Bachelor’s degree in relevant field required

We welcome your expertise, your insight and your enthusiasm to help us develop and commercialize novel drugs that bring new hope to cancer patients.  

• CLICK HERE TO SUBMIT YOUR RESUME TODAY!

 About AVEO

AVEO Oncology (NASDAQ: AVEO) is Passionate in Our Pursuit of Improving the Lives of Patients with Cancer. We are united in our efforts to provide patients with reasons to believe that they can receive effective treatments while carrying on with their daily living. AVEO Oncology is founded on a unique drug discovery and development approach called the Human Response Platform™. With it, we aim to translate cancer biology insights into next generation therapeutics targeted to specific patients living with cancer who will benefit most. The Human Response is more than a novel biology platform – it is our way of responding to the needs of the cancer community with integrity, fierce determination and compassion combined with the confidence that we will transform the lives of those impacted by cancer. This is the AVEO Way – The Human Response.

Agency Notice

AVEO Oncology does not accept unsolicited resumes from any third-party recruiters, agencies or individuals. Any such third party recruiters, agencies or individuals seeking to work with AVEO Oncology must first contact the staffing group at careers@aveooncology.com. Only approved staffing vendors will be allowed to provide services to AVEO Oncology. Unsolicited resumes will be deemed the property of AVEO Oncology to follow up with as it sees applicable and no fee will be paid in the event the candidate is hired as a result of the referral or by other means. Submission of unsolicited resumes does not create any implied obligation on the part of AVEO.

Primary Role:
The Principal Scientist/Associate Director will be involved in pharmaceutical development of Shire HGT’s products. The scope of the work includes formulation development and support of clinical and commercial manufacturing processes. The candidate will participate in CMC teams and cross-functional project teams and may lead/manage CMC and/or PD Teams. The candidate will author and/or review protocols, technical reports, articles and portions of regulatory submissions to support licensure. The candidate will also be responsible for reviewing the design and execution of stability and PC/PV studies. The candidate will work closely with groups in Process Development, Operations, Quality and Regulatory to ensure timely resolution of product investigations. The Principal Scientist/Associate Director will be expected to effectively mentor and develop junior technical staff.

Responsibilities:
40% - This individual will drive the formulation development efforts of Shire HGT programs. She/he will act as Subject Matter Experts for relevant Formulation related investigations.
20% - Manage and mentor a team of technical staff to effectively deliver the project goals related to pharmaceutical development.
20% - Provide strategic and technical guidance and management within cross functional project teams including PD and CMC Teams.
10% - Interface and collaborate with partner functions to ensure timely delivery of mutual goals.
10% - Support department-wide operations including establishing more effective systems and processes, budget management, and resource prioritization.

Education and Experience Requirements:
• PhD in Chemistry, Biochemistry, Pharmaceutics, Chemical Engineering or related field with a minimum of 10 years experience in a (bio)pharmaceutical company and at least 5 years of experience in managing scientists and technical personnel is required.
• Extensive experience developing pharmaceuticals (protein, peptide, nucleic acid and small molecule) with particular emphasis on assay and formulation development.
• Technical expertise in drug product process development and tech transfer, and product characterization is required. Experience with encapsulation technology desirable.
• Experience in developing stability programs, setting specifications and product shelf life, drug product process validation, and product comparability packages.
• Demonstrated technical project management and/or project leadership experience to develop integrated short term and long term project plans
• Effective organizational development and people management skills
• Team player with excellent interpersonal skills
• Excellent written and oral communication skills, with capability to position regulatory technical contents in the CMC area
• Strategic agility and effective program management/leadership skills

Key Skills and Competencies:
• Drive the strategy for the development or improvement of formulation platforms
• Ability to rigorously design complex product development strategies for parallel development of multiple projects.
• Critical evaluation of results and strategic guidance to reach resolution to technical and product development issues.
• Drive and energy to multi-task in a fast-paced environment, with flexibility and strength to navigate through technical crises.

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 and Affirmative Action Employer

To apply for this position, please CLICK HERE

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
In support of Pfizer's Neusentis Research Unit, develop and apply fit for purpose quantitative pharmacology models (e.g. PK/PD and/or systems pharmacology) in support of decisions regarding target prioritization, modality selection, experimental design, lead optimization and early clinical trial design.

Responsibilities
- Collaborate directly with multidisciplinary project teams and external research institutions to develop and implement mechanistic mathematical models of pharmacology in support of project progression (target prioritization, modality selection, experimental design, lead optimization and early clinical trial design)
- Contribute to shaping the translational-research strategy
- Network as appropriate with internal experts in quantitative pharmacology (e.g. Clinical Pharmacology, Pharmacometrics, Biology) to share learnings and enhance consistency in best practices across departments and sites
- Keep up to date with literature concerning targets and indications within the area of pain and sensory disorders as well as mathematical modeling (systems pharmacology & PK/PD).
- Build upon existing personal publication track record and contribute to PDM's external publication/presentation goals

Qualifications
- Ph.D. degree in mathematics, physics, engineering, or other discipline with strong numerical components focusing on modeling and simulation
- 3+ years experience in model-based drug discovery and development
- Prior experience in the area of neuroscience, pain and sensory disorders (preferred)
- Publication record related to modeling and simulations

Technical and Behavioral Competencies
- Ability to learn new areas of biological science and apply quantitative skills to develop impactful models and simulations
- Hands-on knowledge of modeling and simulation software and applications in the area of PK/PD and systems biology
- Ability to translate/condense/ summarize outcomes of modeling and simulation analyses into information that can be used by project teams
- Ability to interact and communicate effectively with colleagues with a variety of backgrounds and across multiple geographical locations
- Excellent understanding of theory, principles and statistical aspects of advanced modeling and simulation
- Demonstrable ability to implement advanced mathematical and statistical concepts into new models
- Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mathematical modeling, systems pharmacology, and salient biology relating to the target of interest
- Motivated to develop a career as a hands-on, technical modeling and simulation expert in a preclinical drug discovery environment
- Keen to interact as a modeling and simulation expert with matrix project teams working closely with PDM, Biology and Clinical scientists

Equal Employment Opportunity

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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site.

Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer.

Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient communuity, and with the compassion and commitment of employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

The Corporate Quality Operations - Systems vision is to support our global corporate customers with efficient and effective systems and processes that meet their needs. Achieving this vision requires the use of creative solutions to solve complex and challenging business problems while doing so cost effectively, timely and while maintaining the required level of compliance.

The Project Manager in CQO-QeSystems will be responsible for leading and managing low to medium risk projects for a wide range of applications that support global quality electronic systems. The projects can span throughout multiple functional areas, facilities and countries which will require the coordination of cross-functional teams.

The Project Manager in CQO-QeSystems will lead and manage low to medium risk projects

Core Responsibilities
- Primarily responsible for limited scope, low risk projects.
- Oversee and manage limited scope, low risk projects for wide range of applications that support the global quality electronic systems; spanning multiple functional areas, facilities, and countries which will require the coordination of cross-functional teams.
- Translate business requirements into project actions / deliverables.
- Ensure all defined / identified project deliverables, timelines and / or assignments have been met on time and within budget.
- Work directly with cross-functional teams in an effective and professional manner.
- Balance customer needs with department / project objectives.
- Project should not require regular interfaces with Vendors. Vendor interaction will be done under guidance of management, Project Specialist Principle or Project Manager Senior.
- Maintain the budget for low risk projects (e.g. creation of Capital Requests and Purchase Orders).
- Work on problems of moderate to diverse scope where analysis of situation or data requires review of identifiable factors.
- Review status of projects and budgets; manage project schedules and prepare status reports.
- Assess project issues and participate in the development of resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
- Monitor project progress for intervention and problem solving with project managers, line managers, and clients.
- Contribute to the completion of organizational projects and assignments.
- Frequent internal company and external contracts. Represent organization on specific projects.

Basic Qualifications
- Bachelor's Degree and 3 - 5 years of experience.
- Master's degree and 1 - 3 years experience.
- 1 - 2 years + years in Project Management, Quality Control, Quality Assurance or equivalent experience.
- 1 - 2 + years in Biopharmaceuticals of related industry.
- Experience in utilizing Microsoft Office PowerPoint, Project Professional

Preferred Qualifications
- Basic understanding of the Principles of Project Management based on the Project Management Institute's Project Management Institute Body of Knowledge (PMBOK)
- Experience in utilizing Microsoft Office Visio Professional
- Regulatory knowledge

To apply for this position, please CLICK HERE

Vertex Pharmaceuticals is seeking an Associate Director of Pharmacovigilance (PV) Quality to join our Quality Compliance Management team in Cambridge, MA.

The Associate Director of PV Quality Compliance Management is responsible for managing Quality Assurance program and interacting with professionals responsible for overseeing internal and external global PV activities related to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPVP), GMP, industry standards and regulations.  Although this role is primarily an individual contributor, this individual may also share responsibility for technical development of team members and ensuring the quality of deliverables within their purview.

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS
- Demonstrates the ability to successfully plan, adjust, manage and optimize all resources (budgets, staff, technology, etc.) for advancement of all goals and objectives.
- Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GPVP regulated activities
- Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process
- Displays highly developed organizational leadership qualities
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GPVP, and quality systems and management.
- Helps craft department goals and ensures linkage to individual goals
- Displays highly effective coaching abilities as well as a successful track record of developing junior staff
- Conduct presentations on quality issues, initiatives and projects at cross functional meetings
- Ensures appropriate systems are in place for monitoring global procedures and practices
- Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.
- May be called upon to act as department head.
- Performs other duties as assigned

KEY RESPONSIBILITIES:  
- Development, implementation, and oversight of quality activities in support of  GPVP activities conducted or monitored by Vertex Pharmaceuticals Inc.  These activities include qualification and monitoring of  GPVP Service Providers, monitoring internal GPVP quality systems, supporting regulatory inspections, performing duties required of an internal Quality Assurance Unit, and building cross-functional agreements on strategic quality initiatives.
- Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements.
- Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests.
- Development and reporting of compliance metrics related to GPVP activities
- Coaches/mentors staff as a means to ensure performance and professional development
- Establishes/maintains effective cross functional team communications to advance quality activities of Vertex.
- This position requires up to 25% travel.

Minimum Qualifications:
-  Master’s degree in a scientific or allied health field  and 7+ years of global GPVP work experience, or
- Bachelor’s Degree in a scientific or allied health field and 10+ years of GPVP work experience,
- 5+ years’ experience serving in a senior Quality Management role
- Ability to travel 25%

Preferred Qualifications
- Managerial experience in planning, budgeting, and personnel development is required.
- Demonstrated leadership skills are critical to this role.
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Powerpoint)

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Temp. contract, 6+ months

The Manager of Clinical Compliance, Risk Management and Training will be responsible for developing systematic approaches and trending to ensure best practices to ensure GCP compliance is integrated into current processes with a focus on subject safety, data integrity and end results. This role will conduct internal and external GCP compliance assessments, test for compliance with company policies and procedures, applicable laws and regulations through inspections of processes and documents. The role will also collaborate and support with Study Execution Teams to identify / address potential or actual non-compliance issues and risk mitigation strategies.

Key Responsibilities:
- Ensure training needs for GMDA associates in the UK are met, in collaboration with functional Training Partners
- Ensurethat service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements
- Ensure appropriate systems are in place for monitoring global procedures and practices
- Conduct presentations on quality and compliance issues, initiatives and projects at cross-functional meetings.
- Maintain a contemporary knowledge of current industry trends, regulations, standards and methodologies as it relates to GCP quality and compliance systems and management
- Identify areas of deficiency or potential risk to the clinical trials through data collection and analysis, perform root cause analyses; collaborate with the clinical teams to implement corrective actions and improvement strategies in clinical areas of concern. Provide oversight, guidance and training as subject matter expert
- Lead / perform internal and external GCP compliance assessments, test for compliance with company policies and procedures, applicable laws and regulations through the inspection of physical operations, processes, retrieval of documents and investigation of irregularities and errors
- Drive / oversee remediation plans and assist teams with integration and follow-up of CAPAs.
- Assist / liaise with QCM department with quality issues and provide regular updates on corrective actions resulting from audit and inspection findings
- Collaborate with CBO (Process Improvement Initiatives, SOPs, training, etc.) to ensure appropriate initiatives are designed and implemented to achieve GCP compliance
- Work collaboratively with Study Execution Teams (SETs) to identify / address potential or actual non-compliance issues and risk mitigation to ensure inspection readiness
- Conduct internal document reviews (Quality Management Plans, Monitoring Plans, Visit Reports, Protocols, etc.) and recommend corrective action
- Compile information and/or prepare reports and analyses setting forth results of compliance activities / assessments with appropriate recommendations; perform subsequent assessments to ensure complete and appropriate corrective action
- Assist in the management of information flow between the GCP QCM group and its customers in clinical development, and follow-up on the audit program, relative to specific projects
- Respond effectively to the demands and changes in the regulatory environment, advising operational management and staff on the impact of this environment on the company and be proactive to determine the adequacy of ongoing programs
- Assist in the development and/or training of investigators / sites as part of non-compliance investigations and / or early escalation of potential non-compliance issues
- Organize regular trainings on compliance issues within Clinical Development in collaboration with the training managers
- Establish/maintain effective cross functional team communications to advance quality activities of Vertex
- Work collaboratively with US compliance team and training teams to ensure global harmonization of applicable initiatives

Minimum Qualifications:
- Bachelor’s degree in a scientific or allied health field
- 5 years of relevant GCP work experience

Preferred Qualifications:
- Demonstrated skills in taking initiative and working independently
- Experience in implementing cross-functional training modules
- Experience in European agency (i.e. EMA, MHRS, IMB, etc) inspections
- Excellent verbal and written communication skills
- Ability to lead and motivate others
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Power Point)
- Expertise related to understanding the principles and application of quality and compliance related to GCP-regulated activities.
- Ability to effectively communicate and influence the outcomes of the decision-making process
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Vertex Pharmaceuticals is seeking a GMP Quality Engineer/ Associate Director to join our team in Cambridge MA.

The Quality Associate Director in this role is responsible for compliance and inspection readiness during technical transfer from development to commercial. This role will also be responsible for representing GMP Quality on compliance initiatives such as continuous manufacturing and Quality by Design during implementation phases and discussions with the Regulatory Agencies. This role maybe responsible for managing and developing personnel.

Key Responsibilities
- Demonstrates broad expertise related to understanding the principles and application of quality and regulatory compliance related to GMP
- Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
- Demonstrates advanced ability to effectively communicate and influence the outcomes of the decision making process
- Displays highly developed organizational leadership qualities
- Proven ability to manage projects/teams of significant scope and complexity, while meeting all deliverables and timelines
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GMP
- Helps craft department goals and ensures linkage to individual goals
- Displays highly effective coaching abilities as well as a successful track record of developing junior staff
- Conduct presentations on quality issues, initiatives and projects at cross functional meetings
- Approves work related travel and expense reports for members of their functional group
- Ensures appropriate systems are in place for monitoring global procedures and practices
- Ensures that service providers, facilities, personnel, procedures, and practices are critically evaluated to consistently meet regulatory requirements.

Minimum Qualifications:
- Master's in a scientific or allied health field  and GMP work experience, or
- Bachelor's in a scientific or allied health field and GMP work experience
- 5+ years experience serving in a senior Quality Management role.

Preferred Qualifications:
- Demonstrated leadership skills are critical to this role.
- Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS Powerpoint)

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Infinity Pharmaceuticals, Inc. is an innovative drug discovery company focused on discovering and developing novel small molecules as cancer therapeutics. Founded in 2001, the company currently has three drug candidates in multiple clinical trials and is aggressively pursuing a robust pipeline of early discovery projects. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences. Through a series of strategic alliances, Infinity is in a position to independently fund the development and commercialization of its drug candidates.

Infinity is looking for a supply chain professional to support the timely preparation and delivery of clinical trial materials for global clinical trials.  This individual will work with the Supply Operations staff to help support appropriate label, package, and distribution activities for clinical trial material at third party suppliers and facilitate production plans and the timely arrival of supplies at testing, supplier and clinical sites. 

This is an exciting opportunity to make a personal difference in cancer and inflammation drug development and be part of a dynamic team.

Responsibilities:

• Provide project based support departmentally as well as cross-functionally with Supply Operations, Clinical Operations, CMC, Quality and Regulatory.
• Responsible for supporting all material deliverables as related to clinical drug materials, including, but not limited to:
  • Perform inventory checks and manage inventory levels of clinical trial materials, labels, packaging, and distribution components.
  • Coordinate and manage drug orders and track drug product shipments to clinical sites and follow up as needed on any shipping excursions.
  • Coordinate label generation and approval process.
  • Coordinate the label and package operations for clinical trial materials.
  • Assist in Supply Operations systems development (e.g. SOPs, forms, templates, etc.)

Requirements:

• Bachelor’s degree, preferably in a science discipline.
• One to two years of experience in pharmaceutical development, with some experience in packaging and labeling design and/or supply chain activities of global clinical trial materials is preferred. 
• Excellent organizational, computer and communication skills.
• Ability to multi-task while maintaining attention to detail.
• Knowledge of current Good Manufacturing Practices (GMPs) and/or Good Clinical Practices (GCPs) is preferred.
• Strong computer skills: Excel, Microsoft Project, and PowerPoint.

To apply please visit our website: www.infi.com/careers-opportunities.asp