Dir, Engineering - CMC Leader for ADC

Job Description

Job Description

The Development and Commercialization Team (DCT) leader is accountable for delivering a fully-integrated stage-appropriate CMC development and commercialization strategy which yields the target commercial product. The specific role will be responsible for advancing the company's Antibody Drug Conjugate (ADC) portfolio. Correspondingly, the DCT leader will be responsible for delivering world class outcomes in the following areas:

• Responsible for on-time, end-to end execution of DCT deliverables including – robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve uninterrupted long-term supply

• Lead DCT.  Critically assesses all team deliverables & fosters a learning and collaborative environment.  Prioritizes, interrogates and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines.  Analyzes and develops innovative solutions to unforeseen circumstances.

• Responsible to ensure the best science and most robust processes are used, working closely with DCRC.  As the Product TPL takes ownership for the products’ technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.  Conducts options analysis and provides recommendation to governance for endorsement.

• Represent CMC and effectively communicates across the governance bodies, stakeholders and teams.  Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influences and challenges the product development team’s strategy to ensure a robust CMC strategy is achieved.  Identifies options to balance Speed/Cost/Robustness & achieve target commercial product.  Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product.

• Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

• Work collaboratively to drive a safe and compliant culture.

Educational Requirement:

• B.S. /M.S. /Ph.D. in one of the relevant Engineering or Science fields. 

Required Experience and Skills:

• Bachelors Degree in life sciences or equivalent with at least 15 years of relevant experience, a Master’s degree (MS) with 12 years of relevant experience, or PhD with 10 years relevant experience

• Must have expertise in ADC development and commercialization.

• Strong cross divisional networking skills and capabilities

• Demonstrated functional and enterprise leadership, ability to influence at all levels of the organization.  

• Strong collaborative skills and the ability to work strategically and in a detail-oriented framework with all levels of management.

• Must have strong understanding of product management systems and tools, strong business and financial skills, ability to manage multiple programs and create a high-performance work environment

Preferred Experience and Skills:

• Experience in Technical product stewardship an advantage

• Demonstrated track record of successfully commercializing multiple large molecule programs across a variety of platforms

• Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly

Core Competencies:

• Development and Commercialization Experience:  Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing.  Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product.

• Technical Depth and Breadth of Experience:  Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes.

• Strategic Thinking/Enterprise Mindset:  Understands and can articulate the “Big” picture, thinks strategically, and demonstrates a customer orientation.  Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness.  Challenges team members to think beyond their area of expertise for the broad