Senior Director, CMC Process Dev - Waltham, MA, United States - Stratacuity: Proven Scientific Placement

Description

Location: Waltham, MA (Hybrid)

Science : Antibody therapeutics

Job Overview: Looking for a driven and skilled manager to lead our client's drug process development and manufacturing team, overseeing internal and external processes to support their clinical development portfolio and contribute to bringing new therapies to patients.

Primary Job Responsibilities:

• Oversee internal process development activities and external manufacturing partners for multiple programs
• Develop phase-appropriate drug substance processes for antibodies and proteins, including cell banking, upstream cell culture, and downstream purification
• Streamline CMC development opportunities and implement strategies, working cross-functionally and collaborating with external partners and internal teams for timely batch disposition and support

Primary Job Requirements:

• Bachelor's, Master's, or PhD degree in a relevant biotechnology or scientific discipline.
• 10+ years of experience in biologics process development with a strong understanding of antibody processing, including upstream and downstream processes.
• Experience managing external CMO's and working in a regulated cGMP environment, with knowledge of cGMP/ICH/FDA/EU regulations.
• Able to work in a fast-paced environment with multiple priorities.

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 PLACEMENT

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.