CMC Lead 2066125

Location: Watertown, MA (Hybrid)

Focus: Antibody

Job Overview: The CMC Lead will oversee strategic planning, collaboration, and technical management of drug development programs for our client, aiming for efficiency and success from initial research to commercial launch.

Primary Job Responsibilities:

• Direct CMC development strategies from pre-IND through late-stage, focusing on efficient process development and supply chain management.
• Manage and approve key CDMO documents, ensuring regulatory and developmental protocol compliance.
• Strategize external partnerships with CDMOs/CMOs to enhance supply chain efficiency and standards.
• Foster collaboration across functions like Regulatory, Clinical, and Quality to align CMC and organizational goals.

Primary Job Requirements:

• Advanced degree ( Ph.D., Pharm.D., or M.S.) in relevant field with 10+ years of CMC experience in biopharmaceuticals.
• Expert knowledge of GMP, ICH, FDA, EMA regulations; skilled in regulatory submissions and tech transfers
• Experience with Antibody drug development
• Strong communication, attention to detail, and ability to manage multiple projects.
• Proven leadership with success in dynamic, fast-paced environments and problem-solving.

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. 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.

EEO Employer

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 employeeservices@apexsystems.com or 844-463-6178.