Director, LMST DCT Leader

Job Description

DCT Leader Role

The Development and Commercial Team leader (DCT) is

Accountable to Development Commercialization Review Committee (DCRC) for delivering a fully-integrated stage-appropriate development and commercialization strategy which yields the target commercial product. 

Leads 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 for end-to-end technical product leadership (TPL) and oversight of the on-time 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 launch on time and uninterrupted long-term supply.

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.

Represents CMC and effectively communicates across the governance bodies, stakeholders and team. Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. Influences and challenges the xDT 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.

Required to comply 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 in GSEC and within the teams that they interact with.

Educational Background and Experience:

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

• Minimum of 10 year’s experience in biopharmaceutical manufacturing and/or development, preferably a majority spent in science and technical role. Experience with product development and new product introduction is required. Demonstrated expertise in technical aspects and interdependencies across DS, DP, device and analytical, regulatory, quality, and supply chain from early development through to commercial manufacturing. Demonstrated understanding of connectivity between clinical, CMC, and Human Health (Commercial Organization) to successfully launch a new product. Ability to navigate through uncertainty to favorable outcomes. Ability to challenge and influence clinical strategies; effectively communicating CMC perspectives and ensuring enrollment and …