Director of Manufacturing

Astra Zeneca (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.

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.

Qualifications:

• 
  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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

What you can expect: great working atmosphere empowering you to reach your full potential, endless development opportunities and benefits like: medical & life insurance, annual bonus, education cost reimbursement, occasional allowances (Christmas, holiday), anniversary awards, additional time off, pension plan, business travel insurance, recognition program, flexible working hours.

Why AstraZeneca?
At AstraZeneca you will be valued. Not only for your unique contribution, skills and background, but because we recognize people are our greatest asset. Here we are dedicated to being a Great Place to Work. Thrive in an energizing environment where challenging work goes hand in hand with development. With opportunities, recognition and bright minds, there’s no better place to unlock learning and build a long-term career. Most importantly, we do meaningful work that changes lives. It’s our purpose that drives us, every day. Interested? Come and join our journey.

The annual base pay for this position ranges from $148,893.60 - $223,340.40 Annual USD. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.