Senior Manager, Cellular Process Development 1137767
Job Scope & Purpose:
Our exceptional Cambridge based client, focusing on the potential of genome editing for a variety of programs in rare diseases, is seeking a talented, highly-motivated individual to build and manage a group within the CMC team. The ideal candidate will be versatile and be able to work with the team to develop processes for cellular products.
Primary Job Responsibilities:
- Manage teams collaborating with Research to transfer processes into PD.
- Performing process development and optimization.
- Manage collaboration with AD to generate data to support formulation studies, stability studies, and characterization of drug substance and/or drug product.
- Manage the compilation and presentation of data to program teams.
- Participate in program teams.
- Manage the authoring and review of batch records, work instructions, technical reports, statements of work and supporting procedures.
- Manage process technical transfer, including generating supportive documentation, training, and technical support to Manufacturing or contract manufacturing organizations.
- Manage and actively participate in, as required, generating reference standards, lead stability samples, forced stability samples, toxicology lots, non-human use (NHU) engineering run lots, and clinical manufacturing run lots, as appropriate.
- Author, review, and provide technical expertise on processes during the preparation of CMC-related regulatory filings for engineered cell medicine programs.
- Support Quality with required data, technical assessments, and expertise, including contributing to management reviews, material specifications, change controls, CAPAs, deviations, stability plans, specifications, OOS results, comparability assessments, and process validation.
Primary Job Requirements:
- PhD (preferred) in a life science discipline such as Biological Sciences, Biotechnology, Pharmaceutical Sciences, or Biomedical Engineering with 5+ years of relevant experience, MS with 8+ years relevant experience or BS with 10+ years of relevant experience
- Experience with applicable cellular manufacturing processes.
- Experience with iPSC and/or Hematopoietic Stem Cell manufacturing processes highly preferred.
- Experience related to the development and/or technical transfer of GMP processes for cellular therapies.
- Knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for CGMP operations.
- Attention to detail and the ability to work individually, within a multi-disciplinary team in a matrix environment, as well as with external partners and vendors.
- Experience building and managing teams effectively.
- Strong organizational skills with the ability to multi-task, problem-solve, prioritize assignments, and adjust priorities to meet goals in a fast-paced environment.
- Strong verbal and written communication skills.
- Strong leadership skills.
- Understanding of product development life cycle and stage gates from research to development to commercial operations preferred.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or