Dir, Engineering, CMC Leader 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 deliver world-class outcomes in the following areas:

• On-time, end-to-end execution of DCT deliverables inclusive of 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.
• Leading DCT and critically assessing all team deliverables & fostering a learning and collaborative environment.
• Prioritizing, interrogating, and mitigating risks across all factors that may impact technical, operational & regulatory success or timelines, analyzing and developing innovative solutions to unforeseen circumstances.
• Ensuring the best science and most robust processes are used, working closely with DCRC, collaborating with the Product TPL to proactively prioritize, interrogate, and mitigate risks across technical, regulatory, and operational factors, and providing recommendations to governance for endorsement.
• Representing CMC, effectively communicating across governance bodies, stakeholders, and teams, and driving outcomes through influence, advocacy, & negotiation.
• Influencing and challenging the product development team's strategy to ensure a robust CMC strategy, identifying options to balance Speed/Cost/Robustness & achieving the target commercial product, and directing necessary technical reviews to ensure robust solutions and approaches.
• Complying with global and regulatory requirements, executing cGMP in day-to-day activities and all applicable job functions, and working 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 ask, too, to ask the right questions... (text truncated)
• Problem Solving and Innovative Thinking
  :
  Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions... (text truncated)
• Ability to Navigate Ambiguity
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  Able to operate and provide direction through ambiguity and adapt plans... (text truncated)
• Productive Communication
  :
  Plans and delivers ideas... (text truncated)
• Collaboration and Teamwork
  :
  Creates, leads, and sustains high-performing teams... (text truncated)
• Drives Results through Accountability
  :
  Demonstrates effective leadership of team activities... (text truncated)
• Influence
  :
  Ability to persuade... (text truncated)
• Ownership
  :
  Proactive mindset ... (text truncated)

Minimum Education al Requirement and

Experience:

• BS  BS … ... (… )

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