Senior Director/Executive Director CMC - AL Solutions

Boston, MA

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

Source : AL Solutions