Director / Senior Director of External Manufacturing
This range is provided by Barrington James. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range:$235,000.00 / yr - $275,000.00 / yr
We are partnered with an outstanding Biotechnology company who specializes in developing targeted therapies that deliver radioactive particles directly to cancer cells. They are looking to bring on a Director / Senior Director of External Manufacturing to join their team! With this position comes a great salary, benefits, and promising career progression within a great company.
Responsibilities:
* Develop and implement a manufacturing roadmap to support the progression of pipeline products.
* Oversee all process development and manufacturing initiatives from preclinical research through commercial launch.
* Identify, engage, and manage external manufacturing partners (CDMOs) to optimize processes and ensure the production of high-quality materials in compliance with cGMP, FDA, and ICH guidelines.
* Assess potential risks and knowledge gaps, proactively developing mitigation strategies with cross-functional teams.
* Provide leadership, guidance, and mentorship to internal teams, fostering a culture of collaboration and technical excellence.
* Guide the development of analytical methodologies and specifications to advance process research for targeted therapeutics.
* Stay informed on evolving CMC regulatory landscapes and contribute to developing phase-appropriate regulatory strategies.
* Act as a technical subject matter expert in discussions with regulatory agencies regarding precursor development.
Experience:
* PhD or MS with 10+ years of experience in pharmaceutical product development and manufacturing. A background in Biochemistry, Pharmaceutical Sciences, or Chemical Engineering.
* Hands-on experience in cGMP manufacturing of small molecules and peptides is required; familiarity with biologics and antibody-drug conjugates is a plus.
* Demonstrated success in managing both U.S. and international CDMOs to ensure timely and compliant production of APIs and drug products.
* Strong interpersonal and leadership skills, with the ability to collaborate cross-functionally and influence the strategic direction of late-stage clinical programs.
* A background in small molecule API as well as biologic manufacturing.
Seniority level: Director
Employment type: Full-time
Job function: Manufacturing, Pharmaceutical Manufacturing
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