Director of Manufacturing

AstraZeneca•Boston, MA

About The Position

AstraZeneca (AZ) is opening a role for a Director of Manufacturing. Reporting to the Head of Radioconjugate Manufacturing, this individual will be responsible for leading the development and production of all small molecule and peptide targeting moieties (precursors) and linkers for the AZ portfolio. This will include managing the internal and external resources required to support the short and long-term goals of the organization. This position requires collaborative skills, multi-tasking ability, and desire to strive in a fast-paced environment. The successful candidate will bring a strong background of GMP manufacturing and management of external vendors. We are a clinical stage company with strategic partnerships, so this is a highly visible and impactful role in our growing organization.

Requirements

PhD or MS with 10+ years of experience in product development and manufacturing; Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline preferred.
cGMP Manufacturing experience in small molecules/peptides is required; experience with biologics and antibody drug conjugates is preferred.
A proven track record leveraging and managing US and international CRO/CDMOs for the manufacture of cGMP APIs and DP to meet aggressive timelines.
Strong interpersonal skills are required, and the successful candidate will work in a cross-functional team and will be expected to influence the direction of the late-stage clinical programs.
Excellent written and verbal communication skills with an ability to convey CMC strategies and results to a varied audience.
Meticulous, self-motivated, decisive, and independent with a willingness to work in a fast-paced start up environment

Responsibilities

Set manufacturing strategy for pipeline of products
Overall responsibility for all process development and manufacturing activities from preclinical clinical development through commercialization.
Identification, selection and management of Contract Development & Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture of Precursors in support of ongoing clinical programs and subsequent commercial supply in compliance with cGMP, ICH and FDA regulations.
Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans.
Manage and mentor internal staff
Understanding and influencing the development of analytical methods and specifications needed to support process research and development of targeting moieties.
Understanding and influencing the CMC regulatory environment to provide a phase appropriate strategy supporting process
Interaction with regulatory agencies, as needed, to act as a technical subject matter expert regarding precursor development.