Sr. Director, Manufacturing (cGMP)

Our client is looking for a Head of Manufacturing that will oversee GMP manufacturing of genomic medicines including autologous and allogenic cell therapies, viral vectors, mRNA, and other modalities. The Head of Manufacturing will be responsible for leading and managing daily manufacturing activities to ensure safe and timely delivery for internal and client programs. The Head of Manufacturing is a key member of the Waltham Site Leadership Team and is a critical interface for our valued partnerships.

As a member of the Waltham Leadership Site Team, the incumbent will be responsible for helping set strategic direction for the site, in alignment with corporate goals and objectives, including transitioning to a commercial ready operation, manufacturing capacity expansion support, and launch of several client products.

Here’s What You’ll Do:

• Lead department to ensure consistent, reliable, timely and compliant manufacturing of products across all modalities at the site spanning clinical and commercial phases.
• Effectively partner with Quality, Facilities and Engineering, Supply Chain, and other functions to maintain procedures and processes for timely release of all manufactured products.
• Develop and maintain training records, operating procedures, and policies in accordance with Current Good Manufacturing Practices.
• Collaborate with process development and other subject matter experts to support internal and partner technology transfers into manufacturing.
• Develop short- and long-term goals for the department in accordance with overall corporate and site objectives. Create, measure, trend, and report manufacturing related KPIs as a basis to drive continuous improvement.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Biotech, Supply Chain, or related field
• At least 15 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
• Direct oversight and experience leading in a commercial manufacturing team required. Direct oversight and leadership of teams > 30 FTEs and over multiple shifts strongly preferred.
• Experience working within a contract manufacturing or client service organization strongly preferred.
• Familiarity with manufacturing architectures and systems (e.g. SAP, electronic batch records)
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.