Our client is a well-funded start-up that is growing rapidly in Cambridge.  Reporting into senior leadership, this position will play a crucial role in the discovery and engineering of novel antibodies.  

The main function of this role is to design and execute antibody discovery and engineering studies and to manage research being performed at CRO/CMO partners and academic collaborators.

Responsibilities include but are not limited to;
• Use of yeast/phage display, affinity maturation, and hybridoma technology to advance projects to preclinical stage.  
• Design and execute antibody optimization strategies including modeling, gene design and expression/purification.  
• Characterization and optimization of pharmaceutic attributes of antibodies for affinity, effector function, immunogenicity and manufacturability.   

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have 2 - 10+ years of experience in post-doctoral and/or industry experience with extensive knowledge of human antibody/immunoglobulin sequences and structure.  The VP has the flexibility to consider candidates at Scientist, Sr. Scientist, or Principal Scientist level.  Title will be commensurate with experience.  

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.  

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

Our client is an international company with several products on the market and a large global presence.

The main function of this role is to lead a team of QA Professionals that collectively are responsible for QA on the floor support of multiple manufacturing facilities at a biologics-focused campus.

Responsibilities include but are not limited to;
•  Site QA floor support oversight and compliance; batch record reviews, deviation review, document
creation, review and management; regulatory inspection preparedness
•  Walk-through audits of site.
•  QA Operations site metrics’ tracking and compliance. 
•  Assuring appropriate GMP and QA systems training of QA personnel. 

Formal descriptions can be supplied for interested candidates. 

Qualified candidates will have BS in a relevant Life Sciences discipline and 7+ years of experience  in a cGMP biotech and/or pharmaceutical manufacturing setting. 

Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge/Lexington area or able to relocate with very limited assistance.  

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

Looking for a highly qualified Ph.D. graduate for a fully funded (2 year), industrial post-doctoral fellowship in an exciting start-up company, developing next generation mass spectrometry applications.

• Operate, maintain and develop methods for LCMS and/or MALDI applications.
• Develop and optimize techniques that identify and quantify cellular post-translational modifications and link these observations to disease pathology and cellular signaling networks. 
• Conduct experiments involving cells grown in culture, and optimize methods for successful MS-based detection of protein/peptide targets. 
• Implement techniques and technologies outside field of expertise to enhance research deliverables.
• Interact with the scientific community to bring new technologies to the group and make recommendations on their utility.
• Work and communicate effectively as a member of the research team across functional boundaries in a dynamic, fast-paced and highly motivated environment.
• Available to mentor undergraduate interns to assist with ongoing research projects
• Prepare written summaries of experimental results and verbally present in team meetings on a regular basis.
• Present and publish work in high-level journals and conferences.

Qualifications

• PhD in analytical chemistry, biochemistry or a related life science discipline, with 0-3 years of related experience.
• Highly motivated individual with excellent time management skills
• A results driven, product-oriented mindset to help commercialize new technology
• Strong skills in mass spectrometry, with an emphasis on proficiency with Thermo and Bruker instrumentation and software as well as downstream data analysis techniques (i.e. Sequest, Mascot, Scaffold, PEAKS, etc).
• Experience in protein labeling techniques in both lysate and in-cell applications. These may include metabolic labeling, chemical labeling of protein & peptides.
• Demonstrated track record in quantitative post-translational modification mapping, such as phosphorylation, ubiquitination & acetylation.
• Experience in plasma membrane proteomics and tissue proteomics is highly desirable.
• Proficient and comfortable conducting and learning an array of basic cell biology techniques such as cell culture, gel electrophoresis, immunoblotting, proteolysis, flow cytometry and other methods.
• Excellent oral and written communication skills and a track record of collaboration with medicinal chemists and biologists.
• High attention to detail, creativity in problem solving, strong interpersonal skills, ability to work independently and as a productive member of a research & development team.
• Fluent in English

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Upstream Process Development Associate / Scientist

Position Summary

We are seeking an experienced and motivated Upstream Process Development Associate/Scientist to join our Protein Production team to contribute to the development of protein-based vaccines for the prevention and treatment of infectious diseases with significant impacts on human health. Applicants should have a M.S. with a minimum of 5 years or Ph.D. (Cell Biology, Biochemistry, Protein Chemistry, Biotechnology, Biomedical Engg). Proven expertise in recombinant protein expression is essential. A strong background in cell culture process development, with an excellent understanding of and experience with process optimization, are required.  Experience with fed-batch and perfusion bioreactor processes with scale-up and GMP manufacturing considerations is preferred. 3+ years of experience in upstream process development is a must.  This position also requires excellent organizational and interpersonal skills.

Primary Responsibilities

• Design and execute experiments for protein production using various expression platforms
• Employ a DoE approach to test and optimize growth conditions in shake flasks
• Protein production in bench top stirred-tank bioreactors and WAVE bags
• Support identification and optimization of alternative laboratory methods and/or equipment to improve work efficiency and throughput
• Optimize existing processes to improve product yield, robustness and impurity profiles
• Document work in notebooks and technical reports
• Prepare presentations for team meetings

Required Skills

• Knowledge of and experience with multiple protein expression systems, e.g. baculovirus, E. coli and mammalian cells, including biomass harvest (centrifugation, depth-filtration)
• Experience with DoE approach to upstream process optimization
• Knowledge of regulations related to biologics manufacturing and testing
• Experience with scale-up and GMP manufacturing considerations is preferred
• Must work well within a fast-paced, dynamic and team-oriented start-up environment
• Experience in development of protein expression arrays is a plus
• Must possess excellent organizational, interpersonal and problem solving skills
• Good presentation and writing skills

Preferred Skills

• Solid understanding of Quality by Design concepts
• Experience with Design of Experiments (DOE) approach for process development

Education & Experience

• M.S. with minimum of 5 years of experience or Ph.D. in Cell Biology, Biochemistry, Protein Chemistry, Biotechnology, or Biomedical Engg
• Minimum 3 years of experience in industry in a biologics process development setting
• Vaccines experience is a plus

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

CLICK HERE TO APPLY: 

http://www.genocea.com/company/careers/posting/upstream-process-development-associate-scientist/

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Analytical Associate Scientist

Position Summary

We are seeking an experienced and motivated Analytical Associate Scientist to join our fast-growing company. The successful candidate will perform development and qualification of analytical methodologies for characterization of protein vaccine candidates. S/he will be responsible for formulation development, support stability programs for various vaccine candidates and provide technical support to process-development-related activities. Applicants should have a M.S. with 7 years or Bachelor with 10 years of industry experience in biochemistry, chemistry, pharmaceutics, or related field.

Primary Responsibilities

• Perform lab-based activities related to the development and implementation of analytical methods as well as formulation development and vaccine stability programs
• Participate in critical interpretation of experimental data
• Participate in practical problem solving activities in relation to ongoing and new projects
• Support process development group
• Write technical reports
• Use of problem solving and technical discretion in the design, execution and interpretation of projects.
• Prepare slide decks independently and present them for internal company meetings.
• Work cross- functionally within organization to achieve common goals.
• Recognize anomalous and inconsistent results and interpret experimental outcomes.

Required Skills

• A solid theoretical understanding of and experience with HPLC, ELISA, Octet, DLS and gel electrophoresis techniques.
• Method development, assay qualification and validation experience is a big plus.
• Ability to analyze data, draw conclusions, communicate results and compile technical reports
• Excellent record keeping abilities to adequately record and document analytical data.
• Displays solid technical knowledge and hands-on experience
• Ability to work effectively in a cross -functional setting.
• Good communication skills and the ability to multitask.
• Hands-on experience with various analytical techniques including HPLC/UPLC, UV-vis and fluorescence spectroscopy, ELISA, Octet, DLS and electrophoresis.
• An understanding of the fundamentals of formulation sciences is preferred.
• Excellent communication, problem solving and analytical skills.
• Strong organization and ability to manage multiple projects simultaneously.
• Strong work ethic and ability to work well both individually and in a team environment.

Education & Experience

• MS in biochemistry, chemistry, pharmaceutics, or related field with significant focus on protein-related studies with more than 7 years of industry experience or Bachelor’s with more than 10 years of industrial experience in protein-based biologics product development, formulation development or pharmaceuticals.

Please reference that you are applying for the requisition numbers MSB139

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Sr. Scientist/Group Leader, EBV

Position Summary

Seeking a top notch contributor to join our dynamic and dedicated team. Reporting directly to the Director of Vaccines in the Vaccine Development group, the Sr. Scientist/Group Leader will be expected to apply an understanding of Epstein-Barr virus (EBV) virology and immunology towards the development of new vaccines candidates against EBV. The candidate will contribute with both technical and intellectual expertise to many levels of a program, including antigen screening and prioritization, adjuvant testing, immunization strategies, animal modeling, and external collaborations. The successful candidate will supervise of a team that supports the evaluation of immunogenicity and efficacy of candidate vaccine formulations in animal models and clinical trials. He/she will develop collaborations to advance Genocea’s EBV strategy through strong alliance management, driving publications, and representing the company at key scientific meetings.

Competencies

•  Excellent communication, problem solving and analytical skills
• Deep knowledge of EBV virology and immunology
• Understanding of EBV-associated diseases
• Solid technical knowledge and hands-on experience with immunological and virological techniques
• Experience in vaccine development

Required Skills

• Plan, implement and directly supervise complex projects
• Assist in developing budgets
• Familiarity with current scientific literature and ability to select methods and techniques for obtaining solutions within accepted practices and procedures
• Provide guidance and supervision to multiple direct and indirect reports, demonstrate leadership skills, successfully develop and manage timelines
• Assume lead role in providing solutions to difficult problems associated with specific projects
• Ensure technical quality and compliance
• Participate in development of patentable technology
• Maintain broad knowledge of state-of-the-art principles and theory
• Make important contributions to scientific projects, draft manuscripts for publication, present technical data at scientific conferences
• Exhibit an exceptional degree of sustained ingenuity, creativity and resourcefulness
• Application and/or development highly advanced technologies, scientific principles, theories and concepts that may be new to the industry
• High-level creative problem solving and analytical skills, using technical discretion in the design, execution and interpretation of experiments that contribute to project goals

Education & Experience

MD or PhD with 7-10 years of relevant experience in infectious diseases, immunology, oncology, virology or related field. Relevant experience in industry is a plus.

Please reference that you are applying for the requisition number MSB140

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Scientist / Sr. Scientist, Immuno-Oncology

Position Summary

The Scientist/Senior Scientist Immuno-Oncology reports to the Head of Immuno-Oncology. He/she is responsible for the discovery and development of T cell antigens for cancer immunotherapy. In addition, the candidate will identify and develop Immuno-Oncology biomarkers.  S/he will design and perform experiments for internally- and externally-focused research programs. The candidate will effectively and routinely collaborate with colleagues in Discovery and Vaccine Development, as well as present scientific results to multidisciplinary teams and the leadership team at Genocea Biosciences.

The Scientist/Senior Scientist will contribute to the external scientific visibility of Genocea through publications and presentations at key scientific meetings and serve as a subject matter expert in immunology and oncology.

Primary responsibilities

• Work collaboratively with other departments to characterize and identify the specificity of T cell responses to tumors and design and evaluate novel immunotherapies
• Support R&D collaborations as a technical expert and scientific liaison
• Critical interpretation of data, including formulation of suggestions for alternate approaches for data generation and evaluation
• Integration with existing project teams
• Drafting of manuscripts for publication in peer-reviewed journals

Required Skills

• Experience in the development of cancer vaccines, including the evaluation of novel adjuvants and delivery systems is critical
• Expertise in T cell culture, flow cytometric methods, and cell cloning is required
• Experience with molecular biology including RNA, DNA and protein analysis is preferred
• Experience with culture of tumor-infiltrating lymphocytes, in silico epitope predictions, TCR sequencing, and processing of human tumors for next generation sequencing is a plus

Candidate must:

• work independently and manage multiple projects simultaneously
• demonstrate the ability to analyze and present data in professional format
• keep up-to-date with the literature related to his/her field
• demonstrate clear and professional verbal and written communication
• work and communicate effectively in a matrix environment

Education and Experience

A PhD or MD/PhD degree in oncology, immunology or tumor immunology related field, with at least 4 years of post-doctoral or industry experience working in tumor immunology or related field with a demonstrable record of scientific achievement is required

Please reference that you are applying for the requisition number MSB141

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Purchasing Administrator (Part-Time, 24-30 hours)

Position Summary

We are looking for part-time purchasing administrator to support the procurement process in a fast paced biotechnology company. The right candidate will have experience with NetSuite; be responsible for the ordering of materials, supplies, and/or equipment; follow through with vendors on shipment and delivery. The candidate will interact with the scientific and administrative staff and process requests in a timely manner.

Primary responsibilities

• Place and process orders
• Reconcile receipt of materials with purchase orders
• Participate in researching and negotiating repetitive purchases.
• Coordinating with suppliers on contracts and reorders of goods and services.
• Monitoring usage history of goods & inventory stock items in coordination with Laboratory Operations staff
• Maintain inventory for office supplies
• Ensure the details of purchase transactions are carried out in a timely fashion
• Follow up on orders to ensure that materials are shipped and delivered on promised dates.

Required Skills

• Have previous procurement process experience and be accustomed to using a computerized system for processing purchase orders
• Be skilled at using Microsoft Excel, Word and PowerPoint
• Demonstrate clear and professional verbal and written communication
• Work and communicate effectively in a matrix environment
• Be detail oriented and possess excellent organizational skills

 Education and Experience

A BS or HS diploma with at least 2 years purchasing experience is required. Experience in the biotechnology field and familiarity with NetSuite or other purchasing software is a plus.

To apply for this position, please CLICK HERE

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Senior Research Associate

Position Summary

We are seeking an Associate to join our Research Department in Cambridge, MA.  The ideal candidate is a motivated, energetic, detail-oriented person who will design and carry out experiments with limited supervision.  Position involves making contributions to experimental design and data analysis.  Must have the capacity to adapt, and demonstrate a strong desire to learn new concepts and techniques.  Expected to work well within a dynamic and team-oriented small company environment.

Primary Responsibilities

• Immunological-based techniques including ELISA-based assays, and functional T cell assays (e.g., antigen presentation, ELISPOT, Luminex, multicolor flow-cytometry).
• Animal modeling of infection and vaccination.
• Cell culture and molecular biology techniques (qPCR, western blots, etc).
• Independently design experiments, analyze data and prepare reports.
• Maintain basic knowledge of principals in field(s) at hand.
• Prepare slide decks independently and present them for internal company meetings.
• Maintain literature files and accurate laboratory records and notebooks.
• Troubleshoot experimental process under minimal supervision.

Required Skills

• A solid theoretical understanding of and experience with cellular and molecular immunology techniques. Assay development experience is a plus.
• Proficiency with in vivo mouse models of infection or disease.
• Ability to analyze data, draw conclusions, communicate results and compile technical reports.
• Excellent record keeping abilities to adequately record and document analytical data.
• Solid technical knowledge and hands-on experience.
• Ability to work effectively in a cross-functional setting.
• Capacity to adapt, with a strong desire to learn new concepts and techniques.
• Excellent communication, problem solving and analytical skills. Strong organization and ability to multi-task.

Education & Experience

Master’s degree with a minimum of 3 years or Bachelor’s degree with a minimum of 5 years of experience in biopharmaceutical industry

To apply for this position, please CLICK HERE

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Bioassay Scientist

Position Summary

Seeking a top notch contributor to join our dynamic and dedicated team. The Bioassay Scientist will be expected to plan and execute experiments as well as analyze data generated by other internal and external contributors. The candidate will have demonstrated hands-on experience with in vivo and cell-based potency assays, technology transfer, data analysis and troubleshooting. The successful candidate will supervise a small team that supports the evaluation of immunogenicity and efficacy of candidate vaccine formulations both in mouse models and in vitro. He/she will work closely with our Biopharmaceutical Development and Production group to support our vaccine development programs with reliability, integrity, and commitment while working in a cross-functional setting.

Competencies and Responsibilities

•  Provide technical resource for bioassay method development, optimization, implementation and validation.
• Assist with feasibility studies and method transfers within and outside of Genocea.
• Routine review of method performance, design and execution of remediation experiments should discrepancies be identified, and development and implementation of improvements to existing assay methods.
• Assist in maintaining critical reagent supply and instrumentation for assigned methods.
• Write animal use protocols, SOPs, validation protocols, and study reports.
• Work collaboratively across organization and sites for method readiness, transfer, performance and troubleshooting.
• Work closely with Biopharmaceutical Development and Production, Vaccine Development, and Translational Medicine team members to understand their deliverables to achieve organization goals.
• Ability to work independently and as a part of a cross-functional team with a positive attitude.
• Performance of in vivo and in vitro bioassays for vaccine development, comparability, potency, and lot release studies.
• Demonstrated experience with bioassay method development, qualification and validation is necessary.
• Experience with vaccine potency assays is a plus.

Education and Experience Requirements

•  PhD with a minimum of 4 years of relevant experience with bioassays and immunoassays in biologics process development.
• Relevant experience in industry is a must.

To apply for this position, please CLICK HERE

www.genocea.com

Genocea Biosciences is a small fast-growing vaccine discovery and development company based in Cambridge, Massachusetts. Genocea is harnessing the power of T cell immunity to develop the next generation of vaccines and immunotherapies. 

Anti-Microbial Vaccines Sr. Scientist / Group Leader

Position Summary

We are seeking a top notch contributor to join our dynamic and dedicated team. Reporting directly to the Director of Vaccines in the Vaccine Development group, the Sr. Scientist/Group Leader will be expected to apply an understanding of microbial host-pathogen interactions towards the development of new vaccines candidates against Chlamydia trachomatisand Streptococcus pneumoniae among others. The candidate will contribute with both technical and intellectual expertise to many levels of the program, including development of the overall strategy, antigen screening and prioritization, adjuvant testing, immunization approaches, animal modeling, and external collaborations. The successful candidate will supervise a team that supports the evaluation of immunogenicity and efficacy of candidate vaccine formulations in animal models and clinical trials. He/she will develop collaborations to advance Genocea’s vaccine strategy through strong alliance management, driving publications, and representing the company at key scientific meetings.

Competencies

•  Excellent communication, problem solving and analytical skills
• Deep knowledge of microbial pathogenesis, host-pathogen interactions, and animal models of human disease
• Understanding of microbial immunity
• Solid technical knowledge and hands-on experience with immunological and microbiological techniques
• Experience in vaccine development

Primary Responsibilities

• Work collaboratively with other departments to characterize and identify the specificity of T cell responses toChlamydia trachomatis and Streptococcus pneumoniae, and design and evaluate novel vaccines or immunotherapies
• Plan, implement and directly supervise complex projects; assume lead role in providing solutions to difficult problems associated with specific projects
• Perform experiments at the bench to test hypotheses
• Support R&D collaborations as a technical expert and scientific liaison
• Draft manuscripts for publication in peer-reviewed journals
• Budget development
• Ensure technical quality and compliance
• Presentation of technical data both internally and at scientific conferences

 Required Skills

•  Critical interpretation of data, including ability to formulate suggestions for alternate approaches for data generation and evaluation
• Familiarity with current scientific literature and ability to select methods and techniques for obtaining solutions within accepted practices and procedures
• Experience mentoring and managing multiple direct and indirect reports
• Demonstrated leadership skills, with evidence of successful development and management of timelines
• Broad knowledge of state-of-the-art principles and theory
• Exceptional degree of sustained ingenuity, creativity and resourcefulness
• Ability to apply and/or develop highly advanced technologies, scientific principles, theories and concepts that may be new to the industry
• Experience working with both Gram negative (i.e. Chlamydia) and Gram positive (i.e. Pneumococcus) organisms
• High-level creative problem solving and analytical skills, using technical discretion in the design, execution and interpretation of experiments that contribute to project goals

Education Requirements

MD or PhD with 7-10 years of relevant experience in infectious diseases, immunology, microbiology or related field. Relevant experience in industry is a plus.

To apply for this position, please CLICK HERE

Position Summary
Moderna is seeking a driven supply chain associate for a fast paced position based at their Cambridge, MA site. The individual in this role will be responsible for the entire lifecycle of synthesized mRNA and drug products/substance from raw material sourcing to customer delivery. They will optimize production work flow for over 400 unique sequences using principles of lean manufacturing and six sigma practices to maximize capacity while minimizing turnaround time throughout the entire production train. The individual will coordinate with informatics and automation teams to develop state of the art systems that enable manufacture and shipment of synthesized mRNA to local and international customers. The candidate will manage multiple supplier relationships to ensure timely delivery of materials, reduce cost, and identify opportunities for expanding Moderna's supplier network. This position will work closely with all production staff as part of the supply chain team and
report to the pre-clinical supply chain manager. The successful candidate will have experience with principles of lean manufacturing in supply chain, developing systems to improve efficiency, and inventory management systems.

Responsibilities
* Build product flow using lean six sigma principles to ensure high worker and machine utilization while optimizing throughput of entire production process
* Identify greatest sources of inefficiency within production to drive process innovation
* Maintain multi-million dollar inventory of all process materials and track consumption to identify needs/trends
* Order raw materials and manage relationship of a worldwide supplier network to ensure constant supply
* Independently develop systems to improve product tracking and improve efficiency of supply chain operations
* Organize shipment of synthesized mRNA and drug product/substance to international and local customers
* Receive raw material shipments; develop a system to catalog, organize storage, QC, and release raw material lots to production
* Coordinate with Moderna departments to ensure accurate flow of information relating to raw material, synthesized mRNA, and drug product/substance

Minimum Qualifications
* Bachelor's in supply chain management, industrial distribution, manufacturing engineering or related field
* 5 years' experience in supply chain, workflow improvement, or related field
* Strong organizational skills and ability to prioritize/multitask
* Exceptional written and oral communication
* Demonstrated ability to critically think and identify solutions

Preferred Qualifications
* Bachelor's in supply chain management, industrial distribution, manufacturing engineering or related field
* Lean six sigma green belt
* Experience in Biochemical or Pharmaceutical Supply Chain
* Strong background in hard science
* Experience developing IT/IS systems to improve efficiency

Competencies
* Flexibility/Adaptability to Change
* Critical Thinking
* Accountability
* Time Management
* Decision making
* Contributing to Team Success
* Tenacity
* Work Standards

Why Join Moderna
Moderna is pioneering messenger RNA Therapeutics™, an entirely new in vivo drug modality that produces human proteins or antibodies inside patient cells, which are in turn secreted or active intracellularly. This breakthrough platform addresses currently undruggable targets and offers a superior alternative to existing drug modalities for a wide range of disease conditions. Moderna has developed a broad intellectual property estate, including more than 250 patent applications covering novel nucleotide chemistries and drug compositions. The company plans to develop and commercialize its innovative mRNA drugs through a combination of strategic relationships as well as newly formed ventures.

Founded in late 2010 by Flagship VentureLabs, Cambridge-based Moderna is privately held and currently has strategic agreements with AstraZeneca and Alexion Pharmaceuticals.

Moderna recently signed a collaboration agreement with Astra Zeneca that provided a $240MM upfront payment (plus milestone payments).

Moderna 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. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please apply at: Application URL:http://www.aplitrak.com/?adid=YWxsaXNvbi5tYXllci41NzYyNC4zMTY3QG1vZGVybmF0aGVyYXBldXRpY3NpbmMuYXBsaXRyYWsuY29t

Primary Role:
The Product Quality Leader- Biologics is an experienced Quality and Technical professional who develops and has stewardship the overall product quality strategy to maximize the benefit and sustainability of Shire's in-line products and to bring Shire's pipeline products to a sustainable existence on the market.
The individual ensures appropriate representation for Tech Ops Quality (QA, QC, Validation and Compliance) functions, on assigned commercial and/or clinical CMC team (s) and works with other Technical Operations line functions, Business Units and R&D to define and execute said strategies.
These strategies include but are not limited to deciding the appropriate sequencing, grouping, content and detail of necessary Health Authority Submissions.

Responsibilities:
35%:
Product Quality Strategy and CMC: Responsibility for Product Quality Strategy and ensuring appropriate Quality Representation on CMC meetings:
* Provide both strategic and tactical quality input to develop sustainable compliant product with continuity of supply (e.g. actively supporting a product science focus regarding continual process verification and fit for purpose elements)
* Facilitate the definition of product critical quality attributes, deliver and drive control strategy, deliver phase-appropriate product specifications. This responsibility is executed by working with line function(s) responsible for development and execution of the control strategy and encompasses
* Product Monitoring and Data trending
* Quality approval of product quality related documents (e.g. Method transfers /validation, data verification of regulatory filings)
* Specification establishment and management

30%:
Regulatory Submissions: responsibility includes ensuring appropriate quality review of regulatory submissions (i.e. filings, annual reports, responses to questions, progress reports for regulatory commitments), ensuring submissions are in line with the strategy set, and are verified for accuracy/data integrity

20%:
Due Diligence and Integration: Provide both strategic and tactical quality input into New Product integration, New platform implementation and New acquisition.

10%:
Tactical Product Quality/ Compliance Governance: Maintain oversight product performance and as needed:
* Participate on or facilitate product quality investigations teams.
* Facilitate change controls, manufacturing process validation, manufacturing process transfer, method transfer, method qualification/ validation and packaging
* Facilitate other Quality related activities in collaboration with their CMC teams.
* Ensure appropriate escalation to Senior Management of significant quality or regulatory issues that may impact patient safety, product quality, supply or regulatory compliance.

5%:
Leadership:
* Participate as a leader in PQM organization and the extended Quality Leadership to ensure direction and support across a matrixed global cross boundary organization
* As appropriate manage direct reports in the Product Quality Lead function to ensure a comprehensive and consistent approach to product quality management is delivered.

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

Please apply at: Application URL:http://www.aplitrak.com/?adid=bGF1cmVuZC4xNTgwMC4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ

Primary Role:
The Business Partner is the liaison and valued strategic partner to the business and IT, accountable for the functional area IT strategy development and a number of portfolios including project, service, and investment, which enable efficient operations, innovation and the achievement of organization goals. The internal clients for this role are Corporate Development - whose constituents include Strategic Planning & Program Management, Strategy, Product Planning, M&A Due Diligence - Communications and Public Affairs, and Legal (including e-Discovery)

Using a consultative approach, this role partners with stakeholders to create strategic alliances and acts as the broker and advocate for technology needs, including projects and IT common and shared services. This role is also accountable for making connections to strategic and major IT service providers.

The Business Partner develops a deep understanding of the business, including knowledge of which technologies are used and why, as well as, how emerging technologies can provide business value.

The Business Partner is accountable for the financial integrity and alignment of IT investments in support of the functional area, maximizing business value of global and local initiatives. The Business Partner is also responsible for ensuring that initiatives are implemented and supported in accordance with Shire's technology standards and compliance and security guidelines.

The Business Partner builds and leads a productive and collaborative organization with a high-performing, innovative and aligned culture.

Responsibilities:
20 - 40%:
Strategic Partnering:
* Develop a thorough understanding of the end-to-end vision for Corporate Development and Communications & Public Affairs (CD, C&PA) and develop and drive an IT strategy that is aligned to each client area's functional and holistic business goals
* Drive technology awareness and cultivate internal demand by leading stakeholder education and awareness initiatives
* Identify, develop and strengthen stakeholder relationships both internal and external to the organization and that extend cross-functionally across all levels of the organization
* Develop deep understanding of which technologies are used, the rationale, and the advantages, drawbacks and costs of these technologies
* Investigate how emerging technologies can provide business value to each client area Challenge existing "best practices"
* Be a trusted advisor to client area's stakeholders, such that the business seeks out input and advice prior to making technology or project investment decisions
* Lead effective and proactive communications with stakeholders of all activities related to IT, including the benefits and impact of enterprise IT projects
20 - 40%:
Plan and Build:
* Lead the development of long-term, multi-year IT roadmap, programs and plans for each client area
* Lead and facilitate each client area's IT planning process and budget discussions, culminating in the prioritized annual investment portfolio
* Lead the development of sound business cases that support, improve and/or transform business operations, processes and strategy and that provide benefit to each client area, evidenced by an ROI/KPI measurement framework
* Provide senior leadership with visibility on projects and initiatives, including the profile, health and performance of each client area's portfolio
* Rapidly adapt to change and define creative, cost-effective solutions for Shire
* Interact and collaborate with IT teams, including other Business Partners, IT architects, IT peers and service partners across the IT organization to ensure understanding of each client area's needs and to deliver solutions to the client
* Collaborate with Service Management to define and deliver application support across the CD, C&PA and Legal respective landscapes
* Follow standard Shire methodology and ensure consistency of solutions with a focus on compliance
10 - 20%:
Team Development:
* People management responsibilities for Business Analysts and other team members
* Coach staff in core IT competencies and seek professional development and job enrichment opportunities for team members
* Proactively contributes to one's own IT team by leading and participating in team meetings & creating a positive work environment
10%:
Run:
* Provide expectation of service levels (OLA or SLAs) and performance to the service management organization
* Collaborate with SIAM (Service Integration and Management) to ensure that appropriate service design and transition work has been conducted prior to transitioning from project to run teams
* Coordinate/oversee work among IT teams to ensure dependencies are understood, managed and communicated
* Manage internal IT-related tasks through implementation and ensure effective transition to appropriate service management teams
5 - 10%:
Financial:
* Prepare annual budget and periodic forecasts for both personnel and investment portfolios
* In collaboration with PM, provide oversight and direction to ensure appropriate financial management of project costs
* Possess a working knowledge of Shire's financial and procurement policies and procedures, including RFx processes

Education & Experience Requirements:
* Bachelor's degree in information technology, computer science, engineering and/or business administration (required)
* Advanced degree in business or technology, such as an MBA (preferred)
* 7-10 years working experience managing and/or directing technology projects and the management and delivery of technology solutions (required)
* More than 5 years working experience in an IT role supporting at least one of the following clients: Corporate Development, Communication & Public Affairs (CD and C&PA) and Legal applications (required).
* Experience with relevant information management systems - including digital and analytics capabilities - required
* Candidate must have experience and proficiencies in at least one of the following three domain / client areas:
* Corporate Development (CD):
* Corporate Strategy
* Product Portfolio Planning
* Business Development
* Due Diligence
* M&A Pre deal support
* Post M&A deal Corporate Functions Integration Lead
* Legal:
* Litigation / e-Discovery
* Records and information Management
* Contracts Lifecycle Management
* Matters management, e-Billing and Legal Hold
* Patent Lifecycle Management
* Corporate Secretariat
* Communication & Public Affairs (C&PA):
* Digital Communications (Intranet / Internet, Digital Asset Management, Video, Signage, Social Media management, Analytics)
* Event Planning
* Internal and external Communications
* Public Affairs (Government Relations Patient Advocacy, Shire in the Community)

* More than 5 years working in the Pharmaceuticals or Life Sciences industry (preferred)

Other Job Requirements:
Dom travel; limited possible int

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

Please apply at: Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjUxNTAzLjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

Primary Role:
The Business Partner is the liaison and valued strategic partner to the business and IT, accountable for the functional area IT strategy development and a number of portfolios including project, service, and investment, which enable efficient operations, innovation and the achievement of organization goals. The internal clients for this role are Corporate Development - whose constituents include Strategic Planning & Program Management, Strategy, Product Planning, M&A Due Diligence - Communications and Public Affairs, and Legal (including e-Discovery)

Using a consultative approach, this role partners with stakeholders to create strategic alliances and acts as the broker and advocate for technology needs, including projects and IT common and shared services. This role is also accountable for making connections to strategic and major IT service providers.

The Business Partner develops a deep understanding of the business, including knowledge of which technologies are used and why, as well as, how emerging technologies can provide business value.

The Business Partner is accountable for the financial integrity and alignment of IT investments in support of the functional area, maximizing business value of global and local initiatives. The Business Partner is also responsible for ensuring that initiatives are implemented and supported in accordance with Shire's technology standards and compliance and security guidelines.

The Business Partner builds and leads a productive and collaborative organization with a high-performing, innovative and aligned culture.

Responsibilities:
20 - 40%:
Strategic Partnering:
* Develop a thorough understanding of the end-to-end vision for Corporate Development and Communications & Public Affairs (CD, C&PA) and develop and drive an IT strategy that is aligned to each client area's functional and holistic business goals
* Drive technology awareness and cultivate internal demand by leading stakeholder education and awareness initiatives
* Identify, develop and strengthen stakeholder relationships both internal and external to the organization and that extend cross-functionally across all levels of the organization
* Develop deep understanding of which technologies are used, the rationale, and the advantages, drawbacks and costs of these technologies
* Investigate how emerging technologies can provide business value to each client area Challenge existing "best practices"
* Be a trusted advisor to client area's stakeholders, such that the business seeks out input and advice prior to making technology or project investment decisions
* Lead effective and proactive communications with stakeholders of all activities related to IT, including the benefits and impact of enterprise IT projects
20 - 40%:
Plan and Build:
* Lead the development of long-term, multi-year IT roadmap, programs and plans for each client area
* Lead and facilitate each client area's IT planning process and budget discussions, culminating in the prioritized annual investment portfolio
* Lead the development of sound business cases that support, improve and/or transform business operations, processes and strategy and that provide benefit to each client area, evidenced by an ROI/KPI measurement framework
* Provide senior leadership with visibility on projects and initiatives, including the profile, health and performance of each client area's portfolio
* Rapidly adapt to change and define creative, cost-effective solutions for Shire
* Interact and collaborate with IT teams, including other Business Partners, IT architects, IT peers and service partners across the IT organization to ensure understanding of each client area's needs and to deliver solutions to the client
* Collaborate with Service Management to define and deliver application support across the CD, C&PA and Legal respective landscapes
* Follow standard Shire methodology and ensure consistency of solutions with a focus on compliance
10 - 20%:
Team Development:
* People management responsibilities for Business Analysts and other team members
* Coach staff in core IT competencies and seek professional development and job enrichment opportunities for team members
* Proactively contributes to one's own IT team by leading and participating in team meetings & creating a positive work environment
10%:
Run:
* Provide expectation of service levels (OLA or SLAs) and performance to the service management organization
* Collaborate with SIAM (Service Integration and Management) to ensure that appropriate service design and transition work has been conducted prior to transitioning from project to run teams
* Coordinate/oversee work among IT teams to ensure dependencies are understood, managed and communicated
* Manage internal IT-related tasks through implementation and ensure effective transition to appropriate service management teams
5 - 10%:
Financial:
* Prepare annual budget and periodic forecasts for both personnel and investment portfolios
* In collaboration with PM, provide oversight and direction to ensure appropriate financial management of project costs
* Possess a working knowledge of Shire's financial and procurement policies and procedures, including RFx processes

Education & Experience Requirements:
* Bachelor's degree in information technology, computer science, engineering and/or business administration (required)
* Advanced degree in business or technology, such as an MBA (preferred)
* 7-10 years working experience managing and/or directing technology projects and the management and delivery of technology solutions (required)
* More than 5 years working experience in an IT role supporting at least one of the following clients: Corporate Development, Communication & Public Affairs (CD and C&PA) and Legal applications (required).
* Experience with relevant information management systems - including digital and analytics capabilities - required
* Candidate must have experience and proficiencies in at least one of the following three domain / client areas:
* Corporate Development (CD):
* Corporate Strategy
* Product Portfolio Planning
* Business Development
* Due Diligence
* M&A Pre deal support
* Post M&A deal Corporate Functions Integration Lead
* Legal:
* Litigation / e-Discovery
* Records and information Management
* Contracts Lifecycle Management
* Matters management, e-Billing and Legal Hold
* Patent Lifecycle Management
* Corporate Secretariat
* Communication & Public Affairs (C&PA):
* Digital Communications (Intranet / Internet, Digital Asset Management, Video, Signage, Social Media management, Analytics)
* Event Planning
* Internal and external Communications
* Public Affairs (Government Relations Patient Advocacy, Shire in the Community)

* More than 5 years working in the Pharmaceuticals or Life Sciences industry (preferred)

Other Job Requirements:
Dom travel; limited possible int

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

Please apply at: Application URL:http://www.aplitrak.com/?adid=anN0Z2VvcmdlLjY0ODg5LjMxNjdAc2hpcmUuYXBsaXRyYWsuY29t

The drug metabolism and pharmacokinetics group at Infinity Pharmaceuticals is seeking a highly motivated individual to coordinate and manage all non-clinical and clinical regulated bioanalytical activities in support of our small molecule drug candidates. The successful candidate will have an in-depth understanding of quantitative bioanalysis as well as a deep understanding of current bioanalytical guidance (including method validation) from regulatory agencies both within and outside the US (e.g. FDA, EMA). This individual will also have a proven track record of successfully managing regulated bioanalytical activities for his or her institution.

Responsibilities:

• Plan, coordinate and manage regulated bioanalysis activities at multiple external contract research organizations (CROs) to support non-clinical and clinical drug development programs
• Review and edit bioanalytical method validation / sample analysis reports and sample analysis plans
• Work with non-clinical and clinical development colleagues to develop regulated bioanalytical support plans to ensure key study (e.g. TK, clinical PK) timelines are met.
• Assist in the authoring, review and editing of TK, PK sections of non-clinical study reports
• Author relevant non-clinical and clinical bioanalytical method development and validation sections of regulatory submission documents
• Provide subject matter expertise to internal colleagues in the field of regulated bioanalysis
• Develop and manage annual budgets for regulated bioanalysis activities based on program goals

Required qualifications:

• BS in chemistry, biology or biochemistry
• 10+, MS with 7+ or PhD with 3+ years’ experience in a position of bioanalytical focus is required
• Previous experience managing CROs in regulated bioanalytical activities is required.
• Attention to detail, effective writing and strong communication and interpersonal skills are required
• Ability to influence and function efficiently in a matrixed environment is required
• Ability to use PK modeling software (e.g. WinNonlin) is required
• Previous or current hands on experience conducting GLP bioanalysis is preferred

This is a temporary position with the potential to become permanent.

Please apply at our website: Http://www.infi.com

Proteostasis Therapeutics is developing disease-modifying therapeutics for cystic fibrosis, genetic diseases and neurodegenerative diseases. The Company's technology combines both phenotypic and target based drug discovery to develop therapeutics that modulate protein homeostasis pathways and correct for imbalances in protein folding, trafficking, and clearance. For more information, please visit www.proteostasis.com.

We seek to hire talented people and to create an environment that facilitates continued professional growth. The extensive and ongoing work with our founders and collaborators adds an outward-looking, collaborative aspect to the company’s culture. This blend of internal and external talent, combined with cutting-edge science and an innovative business model, make Proteostasis Therapeutics an exceptional place to work.

Sr. Scientist II Chemistry        

Position Overview

As a senior scientist, the candidate will be responsible for coordinating supply of active pharmaceutical ingredients (APIs), and development and manufacture of new pharmaceutical products from pre-development through commercialization. We are looking for a highly driven individual who will thrive in our results-oriented, fast-paced environment.

Principal Duties and Responsibilities

Responsibilities include, but are not limited to:

• Manage drug substance and drug product activities from early stage development through commercialization
• Develop and implement strategy and DOEs for optimizing and controlling quality of bulk API and DP using CROs and CMOs
• Execute plans for the validation and registration of API and DP as required by cGMP, ICH and FDA regulations
• Manage Contract Manufacturing Organizations for process optimization, cGMP and commercial manufacturing of APIs and DP
• Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents
• Evaluate and maintain safety, regulatory and compliance standards as they relate to the development of pharmaceuticals
• Prepare technical reports, publications and oral presentations
• Able to identify and resolve critical issues, implement technical, strategic and operation plans
•  Experienced with cGMP manufacturing and IND and NDA filings

Qualifications & Skills 

• 5+ years relevant experience in a pharmaceutical CMC/cGMP environment
• Experience in managing CRO/CMOs for the manufacturing of cGMP APIs and DP
•  Experienced with cGMP manufacturing and IND filings
• Excellent communication, interpersonal and management skills to collaborate on and direct the work of others on assigned projects (including both internal teams and external collaborators).
• Minimum MSc degree in Pharmaceutical Chemistry, Organic Chemistry Pharmaceutics, and/or Pharmaceutical Science, and/or or related scientific discipline required. Advanced degree preferred.
• Excellent written and verbal communication skills.

** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.

Applicants should send a resume and cover letter to: Director of Human Resources at recruiting@proteostasis.com

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

Summary:
As a core member of the Study Team, the Clinical Trial Associate (CTA) has a shared responsibility for the successful execution of assigned clinical trials from protocol concept through clinical study report, in compliance with international GCP guidelines/regulations and ARIAD/Vendor SOPs.  Uses operational expertise to optimize trial design and execution.  Helps to identify and support resolution of clinical trial issues.  Participates in CTA-related process improvement initiatives as required. 

Duties and Responsibilities:

• Tracks metrics and supports the completion of study deliverables. Ensures that protocol deviations are tracked and reviewed.  Tracks and manages essential documentation required for the electronic trial master files (eTMF); Confidentiality Disclosure Agreements; CT.gov and other country-specific registration sites; clinical trial insurance certificates; and, other clinical trial documents as directed.
• Coordinates the set-up and maintenance of eTMF in audit-ready condition, which includes managing the transmittal of required clinical trial documents to Records Management in a timely manner. Assists with quality control (eTMF QC reviews) and assurance activities; assists with resolution of audit findings. 
• Coordinates clinical trial meetings e.g., study kick-off, ST (Study Team), CRA, CRO (Contract Resource Org), and DSMC (Drug Safety Monitoring Committee) meetings by arranging logistics. Prepares the necessary materials for clinical trial meetings; transcribes and distributes the meeting minutes .
• Assists with IP management: including, but is not limited to review of IP (Investigational Product) release documents; tracking of IP shipments, returns and destruction; IP expiry; and, assists with IP supply and integrity issues.
• Creates study-specific site reference manuals, tools, templates and recruitment materials. Prepares study-related documentation and provides input on the design of the Informed Consent Form(s) templates, site monitoring conventions, CRFs, database edit checks, etc..
• Supports medical and operational assessments; assist with the selection of sites and countries for assigned studies; develop effective relationships with investigators and site staff. Participates in the selection and management of external vendors; provides input into vendor specifications.
• Participates in site management visits as appropriate.

Requirements:

• B.A. degree (at hiring manager's discretion if candidate does not have a four-year degree).
• 1 year or more a working knowledge of applicable ICH-GCP guidelines, local regulatory requirements, applicable ARIAD SOPs, and study specific procedures.
• Excellent interpersonal and communication skills, with the ability to work well both independently and as part of a team.
• Initiative and the ability to handle a variety of projects simultaneously and productively with minimal supervision.
• Competent with Microsoft Office and databases.

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

Click here to apply:
http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=595&company_id=16419&jobboardid=306

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

New England Research Institutes (NERI) was founded in 1986 and has grown to become a clinical research organization with a global reputation for high-quality research, innovative thinking, and the use of state-of-the-science tools and techniques. NERI continues to be a leader in public health research, clinical trials management, epidemiology, and state of the art media and dissemination research.

NERI's growth and success has been driven by strong leadership, disciplined attention to scientific integrity, and its ability to attract and retain exceptionally talented staff members. The depth of experience, skill, and expertise that the entire NERI staff brings to each project is what sets NERI apart from other research organizations and is what continues to propel NERI through the 21st century.

We currently have an opening for a full time Senior Research Scientist/Biostatistician. Qualified candidates for the Senior Research Scientist/Biostatistician position will be able to work independently and lead a research team. This position contributes directly to revenue through seeking and securing funding, performing statistical analyses and consultation on study protocols, preparing analysis plans, overseeing the conduct, analysis, preparation of integrated clinical and statistical reports and supervising statistical staff. May have the opportunity to be the lead on or coauthor scientific publications.

Knowledge, Skills and Abilities: 

• Strong experience leading multi-site clinical trials
• Maintain knowledge and awareness of developments in biostatistics and clinical trials methodology and regulatory requirements that impact on statistical analyses
• Solid understanding of pragmatic and adaptive designs and cluster-unit trials
•  Evidence of strong management skills, as shown through management of multiple projects and proven ability to manage, mentor, and motivate staff
• Demonstrated initiative and motivation
• Excellent written and verbal communications skills, including the ability to clearly describe advanced statistical techniques and interpret results
• Good organizational skills with the ability to adapt and adjust to changing priorities
• Positive attitude and the ability to work well with others 
• Strong history of publications in peer-reviewed journals

Qualifications:

• PhD with at least 10 years of experience working on clinical trials
• Advanced degree in Statistics, Biostatistics, or related field
• Strong working knowledge of SAS
• Familiarity with complex statistical methods that apply to Phase I-IV clinical trials
• Proven track-record securing commercial or governmental funding is preferred

NERI is an Equal Opportunity Employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identify and expression, age, disability, Vietnam era or other eligible veteran status, or any other protected factor. NERI is a VEVRAA Federal Contractor.

For more information, or to apply now, you must go to the website below. Please DO NOT email your resume to us as we only accept applications through our website.

https://neriscience.applicantpro.com/jobs/315423-19107.html   

Flex Pharma is searching for a technical leader for a highly visible role as Sr. Director CMC development. The successful candidate will lead CMC functions and collaborate closely with other functions to advance development compounds through clinical to commercial stage. This role is the first hire for Flex CMC and would report into the Vice President of Drug Development.

Roles and Responsibilities

• Develops and oversees CMC product development strategy, planning and execution
• Manages drug supply and ensures accurate forecasting for multiple clinical studies
• Responsible for developing effective working relationships and managing external manufacturing vendors
• Actively contributes to program teams, responsible and ensures alignment of CMC activities with program development plans
• Actively communicates, collaborates with and contributes to other functional areas and drives to achieve the best development and business results of the company
  • Writing global regulatory documents and submissions

Experience, Education and Specialized Knowledge and Skills

The successful candidate has a broad understanding of analytical science, chemical process development and formulation development, and a proven track record in CMC development for clinical stage programs. Excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities.

Other requirements include:

• Advanced degree in Chemistry, Chemical or Biomedical Engineering or related field, PhD preferred
  • 10+ years relevant small molecule CMC experience in the pharmaceutical industry
  • Strategic view and leadership abilities as well as hands on problem solving skills
  • Experience with API manufacture through drug product supply for multiple clinical programs