A central challenge in genomics and medicine is to organize, analyze, and disseminate information derived from datasets that can characterize the genetic basis of disease. The rapidly growing type 2 diabetes genetics knowledgebase aggregates and democratizes these data to the broad biological community. We are supported by consortia for genetics research (the National Institutes of Health funded T2D-GENES project, as well as the Carlos Slim Foundation funded SIGMA-T2D initiative) as well as by public-industry partnerships (the AMP-T2D project).

The group’s goals include:
1) aggregating data from a large collection of genetic studies; (b) scaling up the genetic analyses in order to translate these data into medical knowledge; and (c) serving the results of these analyses to the interested parties around the world via web-based portals. The portal is available at type
2.diabetesgenetics.org.The successful candidate will contribute to the development of multiple websites, using data drawn from a REST API to deliver graphics, tables, and explanations to end-users. Clearly written code with developer-contributed tests is essential, since the modules we write now will be shared across multiple systems and will grow and expand over time. Software engineering tasks will range across our technology stack, from HTML, JavaScript, and CSS on the front end, to coding Grails and Groovy middleware, as well as working with data pulled from both APIs and RDBs.

We use aspects of the Agile process, utilize continuous integration, and depend upon an integrated suite of tests. The successful candidate will work closely with a small team (3-6 members) of engineers, and must also be able to interact comfortably with computational and biological scientists. The working environment is that of a world-class scientific institution, where staff are devoted to the betterment of human health through the application of science. Applicants should be deeply motivated, enthusiastic, and ready to help change the world.

EOE/Minorities/Females/Protected Veterans/Disabilities

To apply for this position, please CLICK HERE

GENERAL SUMMARY/OVERVIEW STATEMENT: 

The Channing Division of Network Medicine (CDNM) focuses on network medicine and systems biology approaches to complex diseases. The Functional Genomics Laboratory, within the CDNM, utilizes in vitro and in vivo models to evaluate the function of genetic variants in complex diseases and to validate hypothesized network interactions. The Research Specialist functions very independently and under the general supervision of the Functional Genetics Laboratory Director. The Research Specialist will be an active participant in the experimental research, mainly in the functional characterization of asthma- and COPD- associated genetic loci and their related gene networks. The Research Specialist will be responsible for developing high-throughput functional genomics experiments within the Functional Genomics laboratory to support a group of Investigators carrying out research in asthma, chronic obstructive pulmonary disease (COPD), and other disorders of the respiratory system.    The Research Specialist performs non-routine, highly specialized molecular genomics experiments (including but not limited to CRISPR-based genome editing methods, 3C (chromatin conformation capture assay), 4C (circular chromatin conformation capture assay), massive parallel reporter assay (MPRA), molecular cloning, and luciferase reporter assays. The research scientist will have the opportunity to present lab work, participate in the modification of research protocols, and contribute to the scientific literature. Specific responsibilities will include design and execution of high-throughput genetic and genomic experiments, as well as assessment and implementation of new methods and platforms. Hiring and supervising laboratory technicians may be required, and assisting the Functional Genetics Laboratory Director in the training of technicians in these methods.      

PRINCIPAL DUTIES AND RESPONSIBILITIES:

1. Establish and optimize protocols for chromatin structure assessment of GWAS loci. 
2. Design optimal experiments for validation of networks, establish appropriate cellular model outcomes relevant to the network of interest derived from different types of Big Data. This includes but is not limited to using siRNA or shRNA for gene silencing in relevant cell types to validate genomics and pharmacogenomics network findings by experimental perturbation targeting key genes.
3. Update existing protocols, archive obsolete protocols, and write new protocols when necessary.
4. Responsible for coordination of assigned projects, including quality assurance, preparing data reports, prioritizing time in order to meet deadlines, and maintain detailed and accurate laboratory notebooks and other records.
5. Establishes new research techniques. Continually evaluates new technology and approaches to existing methods. Maintains active knowledge of current literature in functional genomics.
6. Present experimental results at weekly seminars. Develops rapport and excellent communication with team members.
7. May be required to supervise laboratory technicians, including hiring, performance evaluation, disciplinary action, orientation and training. Train new lab technicians with basic molecular and cellular biology techniques.
8. In collaboration with the bioinformatics team, determines appropriate sample tracking for high-throughput experiments. Tests, troubleshoots, and actively participates in usage and design of in-house LIMS and other software. 
9. Develops and implements rigorous quality control procedures for all experiments. Data integrity checks, quality control verification, and sample and data tracking are required. Learns new data analysis methods for analyzing large data sets. 
10. All other duties as assigned.

  QUALIFICATIONS:

1. Ph.D. preferred. MS degree or equivalent education in scientific field of research
2. 5 to 7 years of direct research experience.
3. Experience in molecular genomics techniques such as 3C, 4C, MPRA, CRISPR, siRNA/shRNA gene silencing, and molecular cloning are highly desirable. 
4. Ability to analyze and interpret large data sets is preferred. Familiarity with R programming, statistical analysis, and other software and bioinformatics tools is highly desirable. 

 SKILLS/ABILITIES/COMPETENCIES REQUIRED: 

•Strong research design and analytical skills.

•Strong database statistical skills.

•In-depth knowledge of field of research.

•Excellent time management/organizational skills

•Ability to independently troubleshoot. 

•Strong written and verbal presentation skills.

•Excellent interpersonal skills and teamwork.      

WORKING CONDITIONS: 

Variety of laboratory/office settings. Exposure to toxic chemicals, biohazardous materials and radioisotopes.  Work may require odd hours to complete experiments.    

SUPERVISORY RESPONSIBILITY:  

May require supervision of more than one direct report. Will train new staff in laboratory procedures.  

Brigham and Women’s Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on the basis of disability.  

Jounce Therapeutics is focused on the discovery and development of first-in-class cancer immunotherapies designed to work not by treating a patient's tumor directly, but instead by harnessing the patient's immune system to seek out and attack cancerous cells and tumors.

Job Title: Corporate Counsel

Reporting to: Vice President of Legal

Location: Cambridge, MA

Position Summary:

We are seeking an exceptional transactional attorney to join our growing internal Legal Department. This individual will be instrumental in supporting the business needs of the company and its ventures by serving as the primary legal contact for transactional matters and related contracting.

Principal Responsibilities:

(including but not limited to)

• drafting and negotiating wide range of agreements, including research collaboration agreements and various license agreements as well as a high volume of R&D related agreements, including confidentiality, material transfer, master service, consulting, clinical trial and contract manufacturing agreements
• drafting and implementing internal legal processes and policies
• counseling and supporting Business Development on collaboration and licensing opportunities

• providing other general corporate legal advice as may be required from time to time in a growing biotechnology company
• Managing outside counsel as needed

Qualifications:

• Admitted to at least one State Bar

• 6+ years of legal and corporate transactional experience
• Prior in-house experience in the pharmaceutical or biotech industry preferred,  law firm candidates with life science practice will also be considered
• Ability to grasp scientific and technical concepts quickly
• Demonstrated ability to think creatively and strategically, with both business acumen and legal skills
• Strong organizational and time management skills in order to balance working on multiple projects in parallel

• Excellent drafting, negotiation and communication skills

• Ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization

Education:

• Juris Doctor from an accredited U.S. law school

To be considered for this role, please submit your resume to Careers@Jouncetx.com with the job title in the subject line of your email.

We are an equal opportunity employer offering a competitive salary and benefits package.

All applicants should be legally entitled to work for any employer in the US.

Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

The Project Manager II provides management and leadership to plan, prepare and execute high quality clinical projects and leads the clinical project team members toward completion of deliverables within an agreed project timeline. General areas of responsibility include: project assessment and initiation, resource procurement and planning, project implementation, leading and motivating a cross-functional team, milestone planning and tracking, ensuring that projects are progressing according to quality standards, Standard Operating Procedures (SOPs), International Conference on Harmonisation (ICH) and/or other guidelines to fulfill local regulations, production of key project progress reports, management of communications between the project team and sponsor, and contract and financial management.

As A Project Manager II You Will...

• Interface internally with database development, clinical data management, SAS programming, biostatistics, and medical writing; and interface externally with the sponsor and external vendors.

• Manage several consecutive project(s) within the approved budgets and timelines. Proactively recognize any change in scope and collaborate with Business Development to ensure timely completion of change orders.

• Develop detailed plans and prioritize the tasks within the plan to achieve project goals. Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.Responsible for overseeing production of clinical project deliverables, including protocol, clinical study report, study manuals, study tools, operational plans, etc.

• Responsible for effective communication within the project team and with functional management. Provide regularly updates regarding the status and progress of the trials.

• Act as the key client contact on assigned projects and develop successful working relationships with client to help secure repeat business.

• Coordinate and provide oversight of all elements of the project lifecycle from initial set-up to final invoicing.

• Responsible for the identification of project risks and the development and implementation of the mitigations for these risks. Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.

• Support the coordination and attend investigator meetings, representing the clinical project team. Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).

• Demonstrate thorough knowledge of and coach others in the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable SOPs and policies.

Experience + Requirements

• Bachelor’s degree preferably in a science, pharmaceutical, or related field. Other professional and/or educational experience may contribute toward the educational minimum requirement, as determined on a case by case basis.

• 3 or more years of CRO or pharma specific experience required. Two or more years of Project Management experience required. Other professional and/or educational experience may contribute toward the educational minimum requirement, as determined on a case by case basis.

• Good working knowledge of drug development process and clinical research methods.

The Senior Manager of Data Standards is responsible for leading and collaborating on projects dealing with the implementation of Standard Data Tabulation Model (SDTM) standards. 

As the Senior Manager of Data Standards You Will...

• Be responsible for oversight of all projects with SDTM component by creating project plans, monitoring project timelines, reporting on project status, identifying project resource needs and understanding contractual agreements to assure successful completion of project objectives

• Serve as an escalation point for sponsor contacts for resolution of project issues, timelines, and project strategy decisions

• Propose project strategies based on outcome of source data review, contract specifications and project timelines

• Provide expertise to Data Standards group in areas such as source data evaluation, authoring data conversion specifications, data conversion and pooling and publishing activities assuring adherence to regulatory standards

• Represent Veristat in multidisciplinary settings, assuring complete communication through participation, presenting and networking within the corporation and throughout the industry

• Be responsible for SDTM compliance and validation using current software accepted by the FDA (WebSDM, OpenCDISC)

• Identify potential process improvements that may increase productivity or quality of the data conversion

• Develop Standard Operating Procedures (SOPs) and standard documents relating to the implementation of SDTM

• Prepare and deliver SDTM presentations and training internally

• Manage staff growth and development through annual objective setting and performance review against goals

• Communicate team / individual goals and expectations to ensure direct reports understand their responsibilities

• Drive data standardization efforts within Data Management group

• Maintain status as a Registered Solutions Provide (RSP) on the CDISC website

Experience + Requirements

• Bachelor’s Degree in Computer Science, Statistics, or related field with a minimum of 8 years of SAS programming experience with clinical trial data and a minimum of 2 years of SDTM compliant implementation experience; Master’s Degree preferred

• Thorough working knowledge of CDISC SDTM Implementation Guidelines

Global cGMP Biologics company seeking a Cleaning Validation Manager to join their team!  This role will  ensure the consistent application of current and future state cleaning validation program elements and concepts as well as integration and development of technical expertise and best practices for equipment cleaning across all Shire manufacturing sites.   Through participation in teams or as the primary POC candidate will own or support elements of the following activities as they pertain to the validation of or validated state of manufacturing process systems: Deviation investigations, CAPA ownership and development, Engineering testing activities, Introduction of new products, Change assessments, Validation protocol review, Review of changes to equipment operating SOP’s.

Manager will be responsible for oversight of cleaning validation activities and projects for the company. Technical duties include implementing validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections. Leadership duties include developing strategy, leading change and motivating others.  The scope of responsibility encompasses the product life cycle for existing commercial pharmaceutical and biopharmaceutical products as well as emerging products and platforms.  Other responsibilities include:

• Lead validation activities for Cleaning Validation, Cleaning Validation Maintenance, Validation document control and archival program. 
• Develop and assess the Quality System elements for Validation such as Quality Risk Management, CAPAs, Change Controls, Deviations, and GMP Investigations.
• Participate and contribute in the design and development of automation, equipment and process/cleaning validation strategy.
• Provide technical input to strategy/philosophy for validation of equipment and automation changes associated with cleaning processes.
• Represent validation during tech transfer activities Identifying current and anticipated requirements for cleaning validation efforts as required.
• Lead technical projects as they pertain to cleaning and cleaning validation. Provide technical input to strategy/philosophy for cleaning validation and engineering changes.
• Front facing during agency inspections for cleaning validation activities.
• Lead and manage complex validation and technical projects.
• Participate and lead partner audits and regulatory agency inspections for Validation.

Requirements:

Bachelor's degree in a technical discipline, preferably engineering or biological sciences & 10+ years pharmaceutical and/or biopharmaceutical industry experience

Please send your resumes directly to brianna@hireminds.com for consideration.  This is a full-time/direct hire role and offers a competitive total compensation package.  Must be authorized to work for any U.S. Employer for an indefinite amount of time.    Relocation available for qualified candidates.

Role and Responsibilities:

Working with the Director of Commercial Training & Development, the person in this position will be responsible for creating and implementing training and development programs. These programs will be primarily focused on Commercial effectiveness and execution. Sets performance metrics, evaluates productivity, and helps the commercial organization achieve short and long-term objectives.

• Assisting, supporting, and leading the development of new and innovative key Sales Force effectiveness initiatives, as well as enhancement of current processes that drive Sales Force Effectiveness;
• Plan the implementation and facilitation of activities and events, budget spending, material production and distribution, and other resources to ensure that operations are managed within authorized budgets;
• Assess needs, Design, Develop, Implement, and Evaluate training programs within commercial organization;
• Assess selling skills, clinical, business acumen and competency knowledge and application of field representatives;
• Conduct new hire training sessions;
• Develop multimedia visual aids and presentations;
• Create testing and evaluation documents and processes;
• Facilitate classroom training, web-conferences and in-field training and workshops;
• Develop, maintain and track LMS related commercial training courses;
• Build strong, productive cross-functional working relationships across the organization;
• Provide logistical support, course development, delivery, evaluation, project management, process measurements, and cost management;
• Possess a “roll-up your sleeves" mindset. Willing to help in any way necessary, including administrative functions related to scheduling, communicating and conducting training programs;
• Assist with the development of strategic plans.

Qualifications and Education Requirements:

• Minimum of 5 years of  field sales experience in the bio-pharmaceutical industry;
• Flexibility - High level of interpersonal savvy, organizational agility, emotional intelligence and the ability to deal with ambiguity;
• Ability to drive Change management/ organizational transformation through collaboration and lateral leadership;
•  Results Oriented – Delivers high impact and value in projects and initiatives;
• Proven track record of taking initiative and operating in a pro-active manner;
• Demonstrated ability to work effectively in a highly collaborative role, and independently when necessary;
• Bachelor’s Degree required.

Preferred Skills:

• 2 years of Renal sales experience with proven track record of sales excellence is preferred;
• 2 years of in-house or field training experience preferred, with understanding of instructional design;
• Strong product management experience;  
• Prior front line Sales Management and/or internal commercial experience;
• Demonstrated aptitude for understanding and explaining complex clinical and business information, including AURYXIA product information and other products in the Renal market;
• Proficient in Microsoft Office (PowerPoint, Word) and web-conference technologies.

Additional Notes:

Overnight travel as required (approx. 20%).

Syros Pharmaceuticals is seeking a dynamic, organized and seasoned administrative / executive assistant to support the growing scientific leadership of our growing pharmaceutical company.  

We are an innovative drug discovery company founded in 2012 by leading scientists from the Whitehead Institute and the Dana Farber Cancer Institute with support from top venture firms and a world class Scientific Advisory Board. Combining new insights into enhancer function with information from genome-wide profiling, we are pursuing new targets and chemical approaches in an effort to unlock the process of gene control for drug discovery.

The candidate must have 10+ years of experience in an administrative support role in a pharmaceutical, biotechnology or similar environment, with at least two years supervisory responsibilities.

 Responsibilities:

• Managing calendars for 5 scientific leaders
• Arranging travel for scientific team
• Manage expense reimbursement for scientific leaders
• Organize and maintain team meeting schedules
• Coordinate company administrative efforts
• Supervise receptionist/ office assistant
• Organization of annual Scientific Advisory Meetings
• Tracking deadlines for conference and publication submissions
• Liaise with lab manager, project manager and Consultants
• Procure journal access and articles for team members

 Requirements:

• BA/BS or similar
• 10+ years’ experience in pharmaceutical or biotechnology environment
• Proven success in coordinating and leading administrative efforts
• Must have strong written and verbal communication skills
• Ability to multitask with a sense of urgency
• Desire and ability to work in a fast-paced environment
• Strong MS Office skills
• Strong interpersonal skills
• Ability to manage up

Foundation Medicine is aiming to build a high-performing, experienced Medical Science Liaison Team to round out our highly respected Medical Affairs Team specifically related to developing and enhancing a strong network of Key Opinion Leaders (KOLs) to support the commercial and scientific efforts and objectives of the company. We are seeking multiple field-based, highly trained Medical Science Liaisons (MSLs) with strong clinical and/or scientific backgrounds and excellent communication skills to initiate and sustain an exchange of scientific information with key external customers and internal teams. Activities include conducting scientific presentations to health care providers, emphasizing the medical and scientific strengths of the company’s existing products, well as with any future company development initiatives. The MSL will address scientific questions, as well as promote and develop access to key thought leaders in their assigned region and utilize these relationships to collaborate where appropriate on educational and research opportunities. This position will report to the VP, Medical Affairs and will require approximately 70% travel. At this time we are considering candidates that are based in any location in the Continental United States.

• Function as a regional MSL specializing in Medical Affairs interactions and initiation and exchange of scientific information with key opinion leaders and other physicians in the oncology and pathology settings
• Facilitate education regarding FMI products in the hematology/oncology and pathology communities as a scientific expert through presentations and scientific exchange
• Help identify and establish relationships with key opinion leaders, clinical and research leaders including academicians, clinicians, medical directors and other HCPs, and provide regular support and education regarding disease state awareness and FMI clinical data
• Respond to scientific/genomic inquiries from HCP customers promptly
• Assist with identification of investigator initiated studies, guiding through the approval process, and monitoring study progress
• Facilitate involvement in national, regional and local scientific forums including symposia, tumor boards and training meetings
• Contribute to scientific messaging for promotional materials, provide competitive insight and work with managers to provide leadership and strategies to develop advocates for the company
• Develop and create materials such as slide decks, training materials, white papers, monographs, case report summaries, clinical synopses
• Integrate efforts with Medical Affairs for organization of scientific advisory boards, key opinion leader management, coordination of clinical trials, and execution of publication strategy
• Gather market intelligence on competitor products and new products in development.

Required Skills

• General understanding of the field of oncology; knowledge of oncogenomics and targeted therapy
• Fundamental understanding of principal cancer patient management algorithms and clinical utility of laboratory-developed molecular tests
• Familiarity with CLIA, LDT, Sunshine Act (2013), AdvaMed Guidelines
• Business acumen (market analysis, market access strategy, territory planning) combined with exceptional interpersonal communication ability
• Existing key opinion leader relationships a plus
• Ability to train/teach others
• Strong matrix management skills
• Ability to travel (domestic) extensively (~70%), often at short notice
• Self-motivated

Education and Experience

• Advanced scientific or medical degree (PhD, PharmD, MD)
• 3 or more years of MSL experience in a diagnostics, biotech or pharmaceutical company. Oncology experience is required.

Apply Here

PI92428899

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.

Responsible for assisting the Sr. Manager in the development, implementation, oversight and management of the company’s/department’s compliance program to ensure the program adheres to all applicable guidelines, industry regulations, laws and/or training requirements. Additional responsibilities of this role will be to identify gaps in department practices, policies, procedures and assume the lead for remediation efforts. This position will ensure that documentation and operations meet established requirements of GMP’s, internal SOP’s and company policies. The objective of this role is to improve the overall quality and efficiency of the Warehouse & Logistics organization. Finally, this person would be cross trained to support warehouse operations as needed.

Job Responsibilities:

• Identify gaps in department practices, policies, and procedures and assume lead for remediation efforts
• Ensure that documentation and operations meet established requirements of GMP’s, internal SOP’s, and company policies
• Improve overall quality and efficiency of the Warehouse and Logistics organization
• Support various warehouse operations as needed

Requirements:

• BS degree in Supply Chain Management, Business or related field
• 5+ years of relevant Warehouse & Logistics experience with the Biotech/Pharmaceutical Industry.
• Experience in a GMP environment is required
• Working knowledge of GMP/DOT/OSHA regulations
• Experience working with CMO’s
• Proactive in approach to work, identifying potential issues well in advance and bringing them to the attention of the appropriate personnel with resolution
• Excellent MS Office and MS Project skills
• Effective analytical skills with demonstrated success in problem solving
• Good communication, organizational and customer service skills are a necessity

Syros Pharmaceuticals is seeking a dynamic and experienced CMC scientist to join a team of highly motivated scientists that are using recent fundamental insights into transcriptional regulation to discover and develop novel medicines targeting gene control.

 We are an innovative drug discovery company founded in 2012 by leading scientists from the Whitehead Institute and the Dana Farber Cancer Institute with support from top venture firms and a world class Scientific Advisory Board. Combining new insights into enhancer function with information from genome-wide profiling, we are pursuing new targets and chemical approaches in an effort to unlock the process of gene control for drug discovery.

 The CMC leader will assume primary responsibility in providing chemical process development, formulation, analytical and manufacturing expertise to Syros’ discovery and development teams. The successful candidate will have subject matter expertise in a CMC discipline, i.e. process chemistry/chemical development, pre/formulation development, analytical chemistry, quality or CMC regulatory. Additionally, the successful candidate will have broad experience in the creation and execution of product development strategies to advance and support novel small molecule assets from preclinical projects through clinical development.

Responsibilities:

• Develop and implement comprehensive strategies to manufacture drug substance and drug product
• Provide expert scientific leadership in the areas of non-clinical CMC to both preclinical discovery project and development project teams.
• CRO/CMO selection & oversight: principle accountability for delivering critical project data through a network of external study providers. Selection and contract negotiation, project design, ongoing troubleshooting, data analysis and interpretation, QC/audit and oversight of study report writing
• Process Chemistry: interface with Syros medicinal chemistry to facilitate rapid, seamless optimization of development candidates into process development. Work with CROs to rapidly access scalable routes for manufacturing of GxP drug substance
• Preformulation/Formulation/Drug Product Development: design and implement formulation strategies to enable toxicology and clinical development for oral and parenteral routes of administration. Oversee the timely and efficient manufacturing of drug product for clinical trial.
• Analytical: Develop and implement analytical method strategies for Syros development projects. Direct the validation of analytical methods and standards to appropriate guidelines and timings.
• Quality: Interpret, effectively communicate and apply all relevant FDA, EMA and ICH guidelines. Develop relevant Syros SOPs as needed.
• Manufacturing & Supply Chain: Establish manufacturing strategy, budgets and goals to ensure a reliable clinical supply chain with well-managed risk.
• CMC Regulatory: Ensure submissions meet current regulatory standards. Author, review and approve CMC portions of study reports, manufacturing process documentation and regulatory filings (e.g. IND/CTA, IMPD, Investigator’s Brochure, PIP, CTD, etc.)
• Flexibility: Must be able to contribute to a portfolio of projects spanning early preclinical discovery through to clinical bringing the appropriate expertise and solutions to the projects
• Leadership: Dependent upon candidate’s leadership aptitude and experience, opportunity to lead a Development Team for clinical-stage project.

Requirements:

• Must have 10+ years of experience in the pharma/ biotechnology industry
• Ph.D. in Chemistry or PharmD in Pharmaceutical Sciences or B.S./M.S. with appropriate experience
• Track record of advancing novel therapeutic agents from discovery into preclinical and subsequent clinical development as Project leader or CMC project team member
• Demonstrated experience in successfully selecting and managing CROs and CMOs to provide high-quality, timely and on-budget studies and product
• Thorough understanding of cGMPs as well as FDA, EMA, USP/PhEur and ICH guidelines
• Experience leading a multidisciplinary project team through successful transitions is strongly preferred
• Experience in successfully developing both oral and parenteral drug products is strongly preferred
• Participation in successful project licensing, due diligence, risk/benefit analyses and tech transfer is preferred
• Experience in using DOE and QbD principles preferred
• Demonstrated strong written and verbal communication skills - the ability to clearly and persuasively articulate complex concepts and strategies to a diverse audience.
• Strong, demonstrable track record of scientific leadership excellence
• Desire and ability to work in a fast paced, cross-functional, flexible and team-oriented environment

Candidates who are enthusiastic team players that have a passion for making a difference in the discovery and development of life-saving medicines are encouraged to apply.

GENERAL SUMMARY OF POSITION:

Cardiovascular laboratory studying the immune and hemostatic function of platelets is seeking a technician to assist with basic science projects.

Projects in the lab involve work with murine and human blood in order to perform in vitro and in vivo studies.

Duties will include:

Must be willing to work with mice

Must be willing to work with virally infected mice and human blood

Requires consistent and well organized documentation in a lab notebook

Follows established procedures in the lab and willingness to learn

Prepares basic solutions

Previous mice experience and ability to infect by intranasal/intra-tracheal delivery is preferred but will be taught if not known.

Under the direction of the Principal Investigator or designee, the Research Associate I performs a variety of complex research experiments.

MAJOR RESPONSIBILITIES:

• Perform complex laboratory experiments
• Conduct in-depth analysis of research experiments
• Interpret data, form conclusions, and decide on and plan the next experiments to be done with a high degree of independence
• Write standard operating procedures, schedule work, analyze data, maintain accurate records, and write reports
• Compile and analyze data. Perform computations using image analysis software, spreadsheets, graphing, and curve fitting software
• May modify protocols and be responsible for a single, independent research project
• May assist with budget and/or operational aspects of grant and contract proposals
• Assist in writing the text of scientific publications and grants. Review literature
• Train new laboratory personnel, students, and collaborators
• Comply with all safety and infection control standards
• Perform other duties as required

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in the Biological Sciences, or equivalent experience
• 3 years of relevant research experience
• Knowledge of Microsoft Office products
• Strong ability to analyze complex visual data in a quantitative and objective manner
• Judgment and action skills required to solve commonly encountered problems

PREFERRED QUALIFICATIONS:

Previous mice experience and ability to infect by intranasal/intra-tracheal delivery is preferred but will be taught if not known

SUPERVISION RECEIVED:

Under the direction of the Principal Investigator, or designee

SUPERVISION EXERCISED:

May functionally supervise aides, technicians, and associates

ENVIRONMENTAL WORKING CONDITIONS:

Wet chemistry laboratory, and may require appropriate contact with biohazards, radionuclides, toxins, animals, and human specimens.

Apply Here

PI92423905

The Position:

The Research Biology group at Sarepta Therapeutics is seeking a research associate to support and advance our antisense drug development programs. This is an exciting opportunity for a highly-motivated, organized, and creative individual to play a central role in developing Sarepta’s RNA-targeting antisense platform, based on our phosphorodiamidate morpholino oligomer (PMO) technology. This position will support research efforts focused on the development of antisense therapeutics for both bacterial infectious diseases and rare genetic diseases.

 Under the direction of a Ph.D. Scientist, the successful candidate will be responsible for laboratory-based target discovery and validation efforts, characterization of mechanism of action of oligonucleotides and coordination of projects from target discovery of novel antisense agents through preclinical proof of concept studies. The candidate must demonstrate a strong focus on experimental consistency and accuracy and have the ability to thoughtfully learn, adopt, apply, and optimize new techniques and approaches. The candidate must be able to clearly communicate experimental results to senior-level scientists, management, and other stakeholders verbally, in writing, and by presentation.

Primary responsibilities include:

• Conduct and optimize in vitro assays to characterize antibiotic PMO efficacy, mechanism of action, and cellular uptake in both bacterial and mammalian cells.
• Assist in the development, optimization, and characterization of in vitro mammalian tissue culture models with the goal of providing a platform for screening of therapeutic agents within Sarepta’s PMO portfolio.
• Taking an active part in designing and developing new biological and chemical assays/screens by adopting and implementing new laboratory techniques based on scientific literature and collaborations.
• Support laboratory activities by monitoring lab equipment and maintaining a clean and safe working environment.
• Demonstrate excellent communication and presentation skills, a documented ability to troubleshoot technical issues, an ability to plan and carry out experiments independently, and to work with complex instrumentation and software.
• Consistantly and accurately document all lab activities in laboratory notebooks and elsewhere as required and appropriate, in a timely fashion. Candidate will author technical reports as needed and contribute to internal and external publications as appropriate.
• Evaluate data and provide clear reports that can be shared and transferred to and from cross-functional teams; responsible for clear communication in both written and oral forms.
• Pay attention to detail, strictly adhere to safety protocols, and use knowledge of basic laboratory procedures to advance projects under rapidly shifting priorities and timelines.
• Works with the business to develop an effective compliance training program, including appropriate introductory training for new employees as well as ongoing training for all employees and managers.
• Evaluates the performance of the Compliance Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness.

Education and Skills Requirements: 

• BS or MS (or equivalent degree) in biological sciences (cell biology, microbiology, molecular biology, biochemistry, molecular genetics)
• 2+ years post-graduate work experience in academic laboratories, biotechnology or pharmaceutical industries
• Experience in aseptic mammalian tissue culture techniques and in bacterial cell culture is highly desired.
• Ability to employ a range of cell and molecular biology techniques such as Western blotting, Gibson Assembly-based plasmid construction, RNA, cDNA and genomic DNA preparation, and quantitative PCR.
• Knowledge of immunofluorescence microscopy techniques is preferred.
• Be highly organized and work with great precision and attention to detaill
• Strong written and verbal communication skills are required.

If you are applying to this opportunity you are an expert in cancer pharmacology models from target validation to translation to the clinic and motivated to take the next step for your career. Are you looking to broaden you skills?  This opportunity with a well-established cancer leader is unique in that it will boarder the best of small molecule and biologic cancer therapeutic disciplines.  You will also have a seat at the helm leading preclinical efforts in cellular biology, pharmacology models, Pk-Pd/DMPK, and translation into Phase I and Phase II studies. You must have a track record of working beyond preclinical studies and clinic success and the ability to influence drug development decisions.  Are you ready to help reinvigorate this excellent teams approaches to innovative cancer therapy and learn from a proven and accomplished team of experts? If so apply today or contact Chris Clancy, Director Discovery & Preclinical at StratAcuity. 

Required and Desired Accomplishments:

• Ph.D. in Pharmacology/Immunology/Cancer-Immunotherapy related disciplines. 
• 5+ years required experience in industry (biotech/pharmaceutical). 
• ​Track record of oncology biology and in vivo pharmacology models. 
• ​Proven leadership of lab teams in preclinical and translational studies with direct clinical correlated successful outcomes. 
• Ability to work in an established pharmaceutical environment with a knack for innovation in oncology small molecule, immuno-oncology, tumor immunity, advanced cancer delivery methods and other cutting edge approaches to cancer therapy pharmacology. 
• Vital skills in effective communication and collaboration across Discovery to Clinically focused peer groups. 

The Head of DMPK and Toxicology is directly responsible for developing preclinical DMPK and toxicology strategies to advance drug candidates from preclinical to clinical development.  The selected individual will serve as the key project member to lead and manage risk assessment and translational activities, including preclinical-related PK-PD, toxicology, safety pharmacology, metabolism, and drug-drug interaction assessments for all projects. The ability to develop, execute, and lead a sound science-based DMPK and toxicology plan to support clinical development is a crucial part of this position. The individual will work closely with the Research team, project leaders, Regulatory, and Clinical to coordinate and manage nonclinical safety activities that expedite the entry of target candidates into clinical trials and to provide continued support to clinical candidates. These activities also include the development of nonclinical sections for IND, IB, and NDA submissions and interactions with regulatory agencies.

Required Functions and Duties

• Work closely with project leaders, CMC, Research & Development, Regulatory, and Clinical in order to develop an overall Toxicology and ADME development plan that supports appropriate and efficient transition of candidate molecules into Phase I-II-III clinical trials.
• Develop appropriate strategies for toxicology testing and risk assessment of lead molecules including pharmacokinetic-pharmacodynamic, metabolism, and drug-drug interactions.
• Participate in research efforts that will accelerate the preclinical development of lead candidates.
• Responsible for managing and directing the study designs and execution of toxicology and ADME studies for all products under nonclinical development. This includes direct interface with the contract research organizations (CROs) to provide input during protocol development phase, derive cost estimates, timelines, study protocols and reports, as well as monitoring study activities.
• Maintain a robust network of CRO and consultant relationships to ensure scalable and flexible
  support capacity to respond to program needs at all stages of development.
• Review nonclinical study proposals and ensure that they fulfill all requirements of the program development plan without excessive use of animals or other resources.
• Review and provide feedback on DMPK and toxicology data for due diligence efforts.
• Develop submissions for INDs and/or NCOs, IBs, and NDAs
• Critically assess the analysis and interpretation of study outcomes and review and edit study reports.
• Report study progress on all nonclinical aspects of product development to the executive leadership team.
• Maintain a current understanding of DMPK and toxicology literature and methodology, as well as for scientific literature related to the disease for the drug discovery projects.
• Maintain a current understanding of regulatory requirements and guidances.
• Generate yearly budgets to support nonclinical programs.

Qualifications

• Ph.D. in Pharmacology or Toxicology or closely related discipline.
• At least 10 years of experience in DMPK and Toxicology with a minimum of 7 years of experience in the Biotech-Pharma industry in leading and managing drug development.
• Proficient in small molecule drug development. An advantage to understand development areas of oncology, ocular, cardiovascular, renal and/or anemia, with an understanding of corresponding animal models of disease and associated translational aspects of drug development.
• Experience in designing, monitoring, and interpreting nonclinical safety studies.
• Record in developing submissions for INDs and/or NCOs, IBs, and NDAs, and with experience interfacing directly with regulatory teams and agencies.
• Management of personnel and creating teams to support nonclinical programs.
• Strong communication, organizational and interpersonal skills, and ability to manage projects and team members in a matrix environment.  Ability to influence without authority.
• Problem solving and organizational skills with attention to detail. Strong team player and strong motivational skills.
• Extensive knowledge of FDA and EMA, and ICH guidance documents including GLP regulations.

Job Description:   Must Haves: -Certificate or BS degree in Life Sciences -Lab experience from school or industry -Solution prep
•Execute defined lab start up and shutdown procedures. •Maintaining a clean and organized work environment in accordance with defined procedures. •Assuring basic lab supply needs are met. •Qualify and maintain Qualification on all assigned manufacturing processes which may include: ◦Synthesis and/or purification equipment cleaning and setup. ◦General solution preparation ◦Lab cleaning and changeover ◦Routine equipment monitoring or maintenance. ◦Monitor automated systems and record operational data. ◦Perform general routine or non technical operations including: ■pH measurements ■UV determinations ■Fraction collection
Requirements: Minimum education requirements high school diploma or equivalent, with college level chemistry or equivalent work experience.  A biotechnology certificate or college degree is preferred.

Downstream Process Development Associate will support the development of biologics.

For details visit:

http://www.cwsciences.com/Current-Openings/Downstream-Process-Development-Associate

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

Compound Management Associate will be a key contributor in a Sample Management Group. The candidate will primarily be responsible for supporting lead optimization processes within Sample Management by fulfilling orders.

For details visit:

http://www.cwsciences.com/Current-Openings/Compound-Management-Associate

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.


Commonwealth Sciences, Inc.
http://www.cwsciences.com

CutisPharma is a specialty pharmaceutical company focused on bringing innovation to the pharmaceutical compounding market.   CutisPharma’s FIRST Unit-of-Use compounding kit franchise has provided significant benefits to pharmacists and patients by replacing traditional compounding with standardized kits that are easy to use, save time, and provide consistent quality.              

We are seeking a talented and motivated QA Analytical Chemist to join our team.  This position will report to the Director of Quality Assurance. 

DUTIES & RESPONSIBLITIES

• Makes recommendations to Quality Assurance management for the disposition of product on Quality Assurance record review and approval.
• Works closely with contract manufacturers and contract laboratories and with other cross-functional impacted areas in a timely manner resulting from record reviews and deviation events.
• Reviews and assesses deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
• Reviews and approves Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
• Creates, reviews, and approves documents including Standard Operating Procedures, Technical Protocols and Reports, Annual Product Review, and other documents.
• Provides support for internal audits and regulatory inspections for cGMP compliance.
• Represents Quality Assurance to guide various projects and technical meetings, as needed.

ESSENTIAL REQUIREMENTS 

• Bachelors (or equivalent degree) in Chemistry or related field
• 3-5 years of quality assurance manufacturing experience in the pharmaceutical industry
• Strong knowledge of API’s: qualifying suppliers, USP analysis (HPLC, GC, and additional analytical analyses), etc.
• Excellent knowledge of pertinent SOPs, cGMPs, and related compliance regulations and guidances.
• Solid computer skills using Word, Excel, and Powerpoint
• Knowledge and application of good documentation practices
• Excellent verbal /writing skills
• Able to execute multiple tasks
• Good interpersonal communication skills/able to work in a team environment

•     Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs)

•     Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met.

•    Excellent organizational, verbal, and technical written communication skills.

ADDITIONAL PREFERENCES •   The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.

• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without neglecting attention to detail

• The ability to enable and drive change while being focused on internal and external customers.

• Capable to manage multiple priorities.

• Proficient in Excel, word and Microsoft Outlook

We recognize hard work and dedication with benefits offerings that address individual needs. Our comprehensive package of benefits for eligible employees includes the following:

• Competitive compensation package as well as bonus  incentives for excellent performance
• Competitive medical and dental insurance
• Paid time off program, including paid vacation, sick and holidays
• Tax-advantaged 401(k) plan with employer match
• Company-paid life and disability insurance
• Anniversary Service Award program

Qualified candidates should submit their resume, cover letter and salary requirements to careers@cutispharma.com

 NO PHONE CALLS PLEASE

 CutisPharma, Inc. is an Equal Opportunity Employer

Our client is a small (

The Hiring Manager is an experienced QA professional who came out of big pharma and has been building the QA insfrastructure at this international company, based locally in the Boston/Cambridge area.

The main function of this role is to execute on Quality Systems and build QMS infrastructure.  

Responsibilities and activities will range but are not limited to;
•  Working with CMO/CRO partners.
•  Batch record review, putting standards and SOPs in place.  
•  Monitor QMS effectiveness and implementation of QMS system.
•  GMP/GLP auditing of external sites.
 
Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have at least 7+ years of experience in GMP QA (for Manager-level).  Must have strong GMP biologics drug substance and/or drug product manufacturing experience.  

This role will be based in the Boston/Cambridge area and will entail some travel.  The Hiring Manager has indicated that 20% is the upper limit of expected travel for both auditing or "person-in-plant" activities.   

Unfortunately, very limited relocation assistance is available at this time. You must live within a commutable distance to the position or be able to relocate with limited financial assistance to be considered.  

All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.