Manager/Senior Manager, CMC, Drug Product 2064423

Location: Boston, MA (Hybrid)

Science: Small Molecule Therapeutics

Job Overview: Seeking a Manager/Senior Manager, CMC, Drug Product to oversee small molecule drug development, manage outsourced development activities, and handle cGMP manufacturing campaigns.

Primary Job Responsibilities:

• Lead CMC drug product projects, including development, optimization, and manufacturing at CDMOs
• Direct process scale-ups and technology transfers ahead of commercial demand.
• Collaborate on refining development and testing methods with internal and external experts.
• Draft critical CMC drug product sections for regulatory submissions, ensuring compliance.

Primary Job Requirements:

• PhD or MSc with extensive experience in chemistry or pharmaceutical sciences.
• 5+ years in pharma with expertise in solid dosage form development and cGMP manufacturing.
• Proven experience in managing CDMOs.
• Knowledgeable in modern solid dosage form technologies.
• Familiar with US, Canadian, and EU regulatory requirements; experienced in regulatory filings.

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.

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.