- Develop and evaluate antibody-based product formulations, drug products, and analytical characterization studies in the laboratory.
- Collaborate with the Discovery group to identify best molecule candidates and support CMC progression from proposal to completion.
- Coordinate and support outsourced CMC development activities, ensuring projects are completed effectively and efficiently.
- Serve as a liaison between internal and external partners, negotiating agreements and facilitating approvals for proposals, work orders, and changes.
- Bachelor, Master, or PhD degree in Life Sciences, Pharmaceutical Sciences, Bioprocess, or Chemical Engineering, or a related field.
- Minimum of 9 years of experience in the biotechnology industry, with extensive knowledge in bioprocess, formulation, and/or analytical strategy development, exposure to GMP manufacturing of biologics, and experience with global contract manufacturing networks and 3rd party relationships for process and product development.
- Strong understanding of biopharmaceutical process development, including biologics (mAB) Drug Substance and Drug Product process development, as well as analytical development and quality control.
- Proven track record in project management, problem-solving, and interpersonal skills, with the ability to work cross-functionally across technical, business, and operational areas.
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Associate Director, CMC Biologics Drug Product 2026530 - Newton, United States - Stratacuity: Proven Scientific Placement
Description
Location: Newton, MA (Onsite)
Science: Monoclonal antibody therapeutics
Job Overview: The Associate Director will lead CMC development activities and collaborate with internal and external partners to oversee and plan CMC development, supporting company growth towards clinical studies and commercial launch.
Primary Job Responsibilities:
Primary Job Requirements:
About Stratacuity:
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 PLACEMENTTM
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.
