Senior Director/Executive Director CMC

1 week ago


Boston, United States AL Solutions Full time
Job DescriptionJob Description
  • 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.

Requirements

  • 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.

Benefits

  • 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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