Director, Biologics CMC/DCT Leader

About the position Dir, Engineering, CMC (DCT) Leader for Biologics 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.

Responsibilities

• 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.

Requirements

• Bachelor of Science (BS) Degree in relevant engineering or science fields with fifteen (15) years of relevant experience; or
• Master of Science (MS) Degree with twelve (12) years of relevant experience; or
• PhD with ten (10) years relevant experience
• 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
• Capital Management
• Change Management
• Chemical Process Development
• Commercialization
• Communication Strategy Development
• Cross-Functional Leadership
• Decision Making
• Drug Development
• External Manufacturing
• GMP Compliance
• Innovation
• Manufacturing Scale-Up
• Mitigated Risks
• Process Improvements
• Product Lifecycle
• Product Management
• Regulatory Requirements
• Stakeholder Negotiations
• Strategic Thinking
• Teamwork
• Writing Technical Documents

Nice-to-haves

• Experience in mAb development and commercialization.
• Experience in Technical product stewardship
• 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
• Expert knowledge in QbD

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

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