Associate Director Process Validation

We are a recruiting company EasyHiring, which is looking for candidates for our partners for a position Associate Director Process Validation in Groton, MA to work in the Devens, MA.

Position Summary

Come, join the Cell Therapy Development & Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Viral Vector Commercial Network Manufacturing Science and Technology (MS&T) group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for an Associate Director for our Viral Vector Commercial Network group. The successful candidate will lead efforts related to vector manufacturing technologies from process performance qualification to GMP manufacturing. The Associate Director will be responsible for overseeing the lifecycle management, process robustness initiatives, process monitoring, manufacturing technical support, including cross-departmental collaboration to enable facility fit of new technologies, development of process documentation (Batch Records, Forms, etc.), training of personnel, change control ownership, and other quality system related deliverables as well as development and support of PPQ strategies and commercial manufacturing. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Associate Director will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products. This position reports to the Senior Director of the Viral Vector Commercial Network group.

Key Responsibilities

• Lead MS&T activities at the viral vector manufacturing site to establish uninterrupted commercial vector manufacturing and supply.
• Leads, Manages, and Coaches process engineers.
• Develop and implement validation policies to define robust process validation program within the cell therapy product lifecycle.
• Participate in generation and approval of PPQ enabling deliverables generated during late-stage process development and characterization.
• Author CMC content for regulatory filings and participate in formal agency meetings.
• Coordinate responses to health authority questions on process validation that require a coordinated response or implementation across cell therapy manufacturing.
• Establish the foundation for technical process leadership for routine commercial batches and on time closure of all quality system records such as deviations, CAPAs and change controls.
• Lead the development, understanding, and management of tools/templates to monitor vector manufacturing process performance and lead the understanding and improvement of process capability.
• Deliver the implementation and execution of process control strategies, including execution of process risk assessments and continued process verification (CPV) thereby ensuring the manufacturing process is in a state of control.
• Ensuring compliance with internal standards and regulatory requirements for process and production related investigations.
• Develop and maintain strong relationships with the manufacturing site and their vendors.
• Ensure permanent inspection readiness and actively support regulatory inspections.
• Lead and deliver on harmonization across the cell therapy manufacturing network.
• Share operational best practices and process learning with the rest of the manufacturing network.

Qualifications & Experience

• Degree in Biochemical, Chemical, Biomedical Engineering or Cell Biology/Immunology discipline with 8 years of experience
• Experience with cellular therapies is desired but not required.
• Prior management experience desired.
• Experience should include technical support of a cGMP manufacturing facility, including strong knowledge and engineering leadership for viral vector manufacturing and processing equipment, manufacturing support and technology transfer.
• Flexibility to work within manufacturing schedules and ability to travel to manufacturing site.
• Ability to work in a self-driven, performance/results oriented, fast paced matrix environment. Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
• Proven project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required.
• Strong interpersonal skills required to work with teams in different functions and organizations.
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab) strongly suggested.
• Detail oriented with excellent verbal and written communication skills.

Travel 20-30% of the time is possible.

Job Type: Full-time

Work Location: On the road