Director/ Senior Director of External Manufacturing
Salary undisclosed
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We are partnered with an outstanding Biotechnology company who company 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, 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.
We are partnered with an outstanding Biotechnology company who company 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, 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.