Associate/Director, MSAT

Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! 

AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO performing safety efficacy and toxicology studies for small molecules and advanced therapies alike, and, most recently, an expansion into manufacturing services for cell, gene, and mRNA-based therapeutics. 

The AmplifyBio ecosystem is comprised of three distinct business units: ADOC (South San Francisco, CA)– Amplify's Discovery, Optimization, and Characterization laboratories: ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the most recently opened AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.  

About AMEC New Albany, OH: AmplifyBio’s Manufacturing Enablement Center provides customizable cGMP suites to enable advanced therapy manufacturing in a “hoteling model,” traditional contract development and manufacturing (CDMO) or a hybrid model. Partnering with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modality is quite different from a typical CDMO experience. The goal is to provide flexible solutions customized to client needs while bringing full expert partnership. At AmplifyBio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

AmplifyBio is seeking to hire an Associate/Director of MSAT to join our growing team!!!

The Associate/Director, MSAT you will lead a team responsible for transferring, developing, and optimizing manufacturing processes into AmplifyBio’s Manufacturing Enablement Center (AMEC) Facility. You will play a critical role in ensuring the robustness, scalability, and compliance of manufacturing processes to support the successful development and commercialization of cell and gene therapy products. This position is hands-on, and requires strong leadership, technical expertise, and a deep understanding of regulatory requirements.

The Associate/Director, MSAT will play a critical role in ensuring the quality, compliance, and efficiency of manufacturing operations within a cutting-edge field of biotechnology!

What You’ll Do Here: 

1. Manufacturing Execution:
   • Lead the tech transfer, development, and optimization of manufacturing processes for advanced therapies, including cell culture, gene editing, downstream processing, fill/finish operations.
   • Establish SOPs, batch records, and work instructions for the production of cell and gene therapy products.
   • Ensure the manufacturing team successfully executes tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operation. 
2. Technology Transfer and Scale-Up:
   • Lead the transfer of manufacturing processes from client organizations to internal clinical and commercial manufacturing sites. 
   • Perform facility fit and generate the necessary documentation for process control strategy (IPCs, PFDs, Process Descriptions) to transition processes from pre-clinical to clinical / commercial GMP manufacturing, ensuring scalability, efficiency, and cost-effectiveness.
   • Prepare and operate equipment, such as bioreactors, centrifuges, chromatography systems, and filtration units, following safety and operational protocols.
3. Quality Assurance and Compliance:
   • Ensure compliance with regulatory standards (e.g., FDA, EMA, ICH) and industry best practices for cell and gene therapy manufacturing.
   • Drive authorship of protocols and reports to enable manufacturing compliance (APS, EMPQ, etc.).
   • Oversee investigations into deviations, implement corrective actions, and ensure documentation of manufacturing activities to maintain product quality and regulatory compliance.
4. Cross-functional Collaboration:
   • Collaborate with cross-functional teams, including client organizations, Quality Assurance, Quality Control, and Supply Chain, to support the tech transfer of cell and gene therapies.
   • Ensure alignment of manufacturing activities with project timelines and regulatory requirements.
5. Process Validation and Regulatory Submissions:
   • Lead process validation activities, including protocol devel