Director of Manufacturing

Astra Zeneca(AZ)is opening a role for aDirector of Manufacturing.Reporting to theHead ofRadioconjugateManufacturing, this individual willbe responsible forleading the development and production of allsmall molecule and peptidetargeting moieties (precursors)and linkersfor theAZportfolio. This will include managing the internal and external resourcesrequiredto 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,selectionand management of Contract Development & Manufacturing Organizations (CDMOs) for process optimization, cGMP manufacture ofPrecursorsin support of ongoing clinical programs andsubsequentcommercial supply in compliance with cGMP,ICHand FDA regulations. 

• Proactivelyidentifyknowledge 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 oftargetingmoieties.

• Understanding and influencing the CMC regulatory environment to provide a phaseappropriate strategysupporting process 

• Interaction with regulatory agencies, as needed, to act as a technical subject matter expertregardingprecursor development. 

Qualifications:

• PhD or MS with 10+ years of experience in product development and manufacturing; Advanced degree in Biochemistry, Pharmaceutical Chemistry, Pharmaceutics, Pharmaceutical Science, ChemicalEngineeringor related scientific discipline preferred. 

• cGMP Manufacturing experience in smallmolecules/peptidesisrequired; experience withbiologics andantibody drug conjugates is preferred. 

• A proventrack recordleveragingand managing US and international CRO/CDMOs for the manufacture of cGMP APIs and DP to meet aggressive timelines. 

• Strong interpersonal skills arerequired, 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