Job DescriptionJob #: 977747
Associate Director, Director, Cellular Process Development, 977747
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 tasked with developing clinical manufacturing processes and their supporting process control strategies. The ideal candidate will be versatile and be able to work with the team to develop processes for cellular products derived from different lineages of cells.
Primary Job Responsibilities:
- Lead collaborations with Analytical Development to develop understanding of critical quality attributes of engineered cell medicines
- Direct efforts to develop documentation to support developed processes and process control strategies
- Lead efforts to develop processes and create inventories of process representative cells to support internal Pipeline and Platform teams
- Facilitate team’s interface with colleagues in Platform and Pipeline to achieve successful clinical translation
Primary Job Requirements:
- Advanced life sciences degree and 10+ years of multi-disciplinary experience in the cell therapy/biotech/pharmaceutical industry
- Experience in development and technical transfer of cellular therapy manufacturing processes
- Advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles for GMP and GTP operations
- Exceptional organizational skills with the ability to multi-task and prioritize assignments, strong problem-solving skills, self-motivated with ability to work under pressure to meet deadlines
- Demonstrated technical proficiency, scientific creativity, independent thought and ability to effectively collaborate with others
- Strong team player who has excellent verbal and written communication skills and is solution oriented with a customer service approach
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.
PROVEN SCIENTIFIC PLACEMENT™
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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 844-463-6178-6178.