Affinia Therapeutics (https://www.affiniatx.com/) has partnered with HireMinds to identify top talent as they build out their Process Sciences group at a new state-of-the-art facility in the suburbs outside Boston. They raised a Series A of $60 million in March 2020 and a multi-year partnership with Vertex in April 2020. As one of the critical first hires, they are seeking an experienced Process Development leader to provide technical, operational and strategic leadership and expertise in the development, tech transfer, manufacturing support and CMC operations of rAAV gene therapy products.
Reporting to the Chief Technology Officer, the main function of this role is to serve as the head of the rAAV vector process development organization, which includes cell culture development, purification development, and formulation development.
Responsibilities include but are not limited to;
• Overseeing all process development efforts for Affinia Tx and driving development, optimization and implementation of manufacturing processes for pre-clinical and clinical stage programs
• Ensuring scope of all process development activities is aligned with non-clinical, clinical, CMC, and corporate timeline and budget requirements
• Establishing plans and protocols to develop, troubleshoot, oversee and support efficient technology transfer of modified/optimized manufacturing processes to partner CMO’s and (future) internal GMP manufacturing team to support clinical programs
• Identifiing sources of critical raw materials and activities or events that may critically affect supply chain. Assuring that suppliers are meeting stage-appropriate GMP standards and developing appropriate specifications for critical raw materials, intermediate components, and final product release testing
• Overseeing all aspects of job-related experimental design, protocols and interpretation of results, recording of data/results, reports, and effective communication of such with stakeholders, including work products from other team members
• Establishing robust, compliant, scalable and economically feasible GMP manufacturing processes including performing COGS analyses and risk assessments (quality, robustness, operability)
• Assisting in preparing manufacturing master batch record and test method batch record in collaboration with partner CMO’s and (future) internal GMP/QC teams
• Overseeing the writing of Standard Operating Procedures (SOPs) to support process development and cGMP manufacturing needs
• Providing technical and strategic input and driving continuous improvement to the manufacturing process through technological innovation to support ongoing product development efforts
• Assisting in preparing regulatory filing documents and providing responses to questions from U.S. and ex-U.S. health authorities as Subject Matter Expert (SME) in process development
Formal descriptions can be supplied for interested candidates.
Qualified candidates will have an advanced degree (MS or PhD) in chemical engineering, biochemical engineering, biochemistry or other relevant discipline and 15+ years of relevant industry experience in gene therapy/vaccines/complex biologics process development. Ideally, you will have experience with development and CMC of rAAV gene therapy products, as well as working knowledge in molecular biology aspects and gene therapy analytical aspects. Must have in-depth technical and regulatory understanding of GMP biologics manufacturing, as well as applicable international regulations and standards in all phases of product development and commercialization. Thorough knowledge of AAV manufacturing process and analytical development, cGMP manufacturing, process automation, technology transfer and clinical supply management is essential. Must have working knowledge of pharmaceutical GMP’s and ICH guidelines. Thorough understanding and working experience with Quality by Design (QbD) is highly desirable
As a key leadership role in the company, you must have demonstrated experience building and leading high performing teams with the desire and ability to work in a fast-paced environment. Demonstrated troubleshooting skills with the ability to “think outside the box” and experience interacting with non-clinical, clinical, quality control, quality assurance and regulatory affairs departments will also be essential.
Must be authorized to work in the US indefinitely to be considered and must be commutable to the Cambridge area or able to relocate with very limited assistance.
All resumes will be kept strictly confidential until you choose to pursue a specific opportunity with one of our clients.