Executive Director, Process Development

Career Category

Process Development

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission—to serve patients—has driven our status as one of the world’s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high-level expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Executive Director, Process Development

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What you will do

Let’s do this. Let’s change the world. In this vital role as Executive Director, Process Development you will be a part of Process Development, Drug Substance Technologies – Synthetics (DSTS) and play an important role in developing and delivering robust drug substance manufacturing processes and technologies to serve patients.

DSTS is an integrated end-to-end organization that is accountable to Invent, develop, and implement drug substance manufacturing processes and technologies to advance and sustain Amgen’s synthetics and hybrids portfolio.

This team operates as a matrixed organization relying on integration, centers of expertise and fungibility of resources to maintain and continuously improve process development contributions to our synthetic portfolio.

The Executive Director of DSTS is responsible for leading the synthetics team and serving as the primary department representative for Synthetics Drug Substance Technologies on departmental and interdepartmental work to advance and commercialize the synthetic portfolio, inclusive of hybrid modalities (peptides, oligonucleotides and bioconjugates).  This role reports into Vice President, Drug Substance Technologies.   

Responsibilities

• Accountable for developing and ensuring that the DSTS vision, mission, and strategy are implemented and upheld

• Accountable to rapidly advance a diverse synthetics portfolio of molecules (including small molecules, bioconjugates, ADCs, peptides, oligonucleotides), from research through to commercialization working with our Partners across Operations and our internal and external manufacturing network

• Back-integrates into R&D, to provide advice on the Target Product Profile, Synthetic Process Challenges and Final Form to advance the candidates into the clinic.

• Forward-integrates into the commercial network and partner with the Amgen Contract Development and Manufacturing (ACDM) organization to Tech Transfer our synthetic processes in the external Manufacturing Network and inform them of potential issues to set them up for success in commercialization efforts

• Establish and maintain partnership agreements with peer organizations, e.g. ACDM, Attribute Sciences (AS), Drug Product Technologies (DPT), Quality, Regulatory, Clinical Supply and Commercial Manufacturing (internal and external)

• Represent Drug Substance Technologies as a scientific, regulatory and technical expert both internally and externally

• Designate project representative responsibilities as appropriate

• Manage company-wide and department level activities (e.g. budgeting, capital allocation, project assignment, alignment initiatives, setting vision/direction/strategy and technology development)

• Participates in, or organizes, departmental committees to address departmental and interdepartmental initiatives

• Ensures that staff performance and career development are managed and succession plans are active and advanced

• Ensure that industry standards and best practices that fit Amgen’s business needs are effectively applied

• Stays abreast of issues that may impact the DSTS business

• Evaluate, resolve and/or escalate issues in a timely manner

• Responsible for developing next-generation leaders from within the function and building strong succession plans across all levels in DSTS

SCIENTIFIC/TECHNICAL

• Serves as a technical expert and keeps current in drug substance development, including literature and technology development for cutting edge and regulatory driven activities

• Provide support to Drug Substance Team Leaders for regulatory submissions, investigations, and product development (supporting ACDM, DPT, AS, Quality, Regulatory and clinical supply)

• Extensive knowledge of GLP and GMP activities

• Understands the technical and/or scientific capabilities of the department and provides guidance to senior staff members to resolve scientific/technical