Director – Msat

The Role:

 ElevateBio is looking for an outstanding candidate for a leadership position to join our Manufacturing Science and Technology Organization in support of our growing client portfolio for genomic medicines.  This role is responsible for leading process performance qualification (PPQ, process validation)  and commercial readiness activities in support of advanced therapies. This leader will lay the technical foundation for the process validation program while building a team of engineers to support commercial manufacturing. Candidates should have extensive experience with biologics/CGT manufacturing in a commercial GMP setting, PPQ planning and execution, supporting regulatory filing and inspections, hiring and managing staff and working within highly matrixed cross-functional teams.

Here’s What You’ll Do:

• Lead and manage commercial readiness and PPQ activities ensuring compliance with regulatory standards and company policies.
• Design and establish process validation framework including creation of policies and SOPs in collaboration with key stakeholders such as quality assurance.

• Collaborate with cross-functional teams, including external client teams as well as internal Quality, Regulatory Affairs, and Manufacturing, to ensure seamless execution of PPQ activities.
• Oversee the preparation and review of PPQ protocols, reports, and related documentation.
• Oversee the design and execution of supporting BLA enabling studies such as filter validation, shipping validation, aseptic process validation etc
• Establish and oversee continued process verification (CPV) program using state of the art digital technologies
• Support raw material and consumable program as a process SME
• Establish and support life cycle management program for post approval changes.
• Ensure successful delivery of commercial batches  in partnership with Manufacturing, Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
• Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.)
• Actively support PAI readiness and regulatory inspections of BaseCamp Waltham site.
• Build and grow a team of talented engineers or scientists to support PPQ and future commercial batches.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Science, or related field. Master’s or Ph.D strongly preferred.
• At least 12 years of experience in a MSAT, Process Development or GMP environment supporting complex biologics products. Experience in autologous gene or cell therapy a plus.
• At least 5 years of managerial experience in hiring and managing direct reports.
• Extensive experience in leading process validation and commercial manufacturing support.
• Demonstrated ability and strength in leading cross-functional technical teams within a matrixed organization.
• A strong technical leader who can problem solve while balancing business needs with technical risks within a regulated environment.
• Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., ICH guidelines).
• Prior experience with regulatory submission and regulatory inspection is strongly preferred
• Experience with digital tools used in manufacturing operation (eg. eBR, SAP) and fundamental understanding of data and statistical analysis.
• Excellent project management, organizational, and communication skills including communication with senior leadership and external stakeholders.
• Experience working within a contract manufacturing or client service organization strongly preferred.