Senior Director/Executive Director CMC
AL Solutions Boston
Build and lead CMC teams dedicated to the development and optimization of protein biologics processes.
- Utilize your CMC expertise to steer the nomination of Development Candidates.
- Select and collaborate with CDMOs; craft contracts in partnership with Executive Leadership and Finance.
- Oversee the transfer and management of manufacturing processes with CDMOs, ranging from candidate nomination to process and analytical development, and advancing to early phase clinical manufacturing.
- Facilitate the transfer and support of analytical methods at external CROs/CDMOs.
- Direct analytical and stability programs at CROs to ensure the highest quality.
- Prepare and review technical documents and reports essential for regulatory submissions.
- Define and manage objectives, operating plans, production milestones, and overall goals for CDMO/CRO contracts.
- Spot opportunities to expedite manufacturing processes to ensure timely clinical starts.
- A Doctorate in Biochemistry, Biology, Bioengineering, Immunology, or a related discipline is required.
- Minimum of 15 years of experience in the pharmaceutical and biotech sectors, with considerable management experience in the development and manufacturing of protein therapeutics.
- Experience in technology transfer to Contract Development and Manufacturing Organizations (CDMOs) for both non-Good Manufacturing Practices (non-GMP) and Good Manufacturing Practices (GMP) manufacturing, encompassing cell line development, process development, and scale-up.
- Expertise in the formulation of research strategies, operational management, and budgetary planning.
- A profound understanding of the drug development lifecycle, with experience in research and clinical environments.
- Proven ability to devise innovative solutions to achieve ambitious objectives and influence company direction.
- Familiarity with bispecific protein products is preferred.
- Skilled in the preparation of technical documentation for regulatory submissions.
- Demonstrated leadership and personnel management capabilities, accompanied by effective communication across various functions.
- Able to facilitate strategic discussions with senior management and external partners.
- Willingness to travel both nationally and internationally to oversee relationships with CDMOs.
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k, IRA)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
- Family Leave (Maternity, Paternity)
- Short Term & Long Term Disability
- Training & Development
- Flexible on site schedule
- Wellness Resources
- Stock Option Plan
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