Dir, Engineering, CMC Leader for Biologics

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 biologics 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.

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 broader interests of the company and patients we serve.

• Problem Solving and Innovative Thinking:  Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems.  Ability to leverage scientific expertise and growth mindset to interrogate data and foster debate within teams to enable innovative and robust problem solving. 

• Ability to Navigate Ambiguity:  Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, and/or new information.  Capable of both directive and consensus facilitation and awareness of when to apply each.  Leverages scientific data to make disciplined risk-based decisions and shown to be capable of discerning between risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply.

• Productive Communication:  Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise.  Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members