Associate Director, Manufacturing; GMP

Position: Associate Director, Manufacturing (GMP)
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 Amplify Bio!

Amplify Bio 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 Amplify Bio 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:
Amplify Bio'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 Amplify Bio 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 Amplify Bio drug developers will find an innovation-rich ecosystem designed to advance a diverse range and class of pharmaceutical products across development stages.

Amplify Bio is seeking to hire a (Sr.) Manager/Associate Director of Manufacturing to join our growing team!!!

The (Sr.) Manager/Associate Director, Maufacturing at Amplify Bio's Manufacturing Enablement Center (AMEC) Facility is responsible for leading and overseeing the manufacturing operations within a GMP-compliant facility specializing in advanced therapies. This role involves managing all aspects of manufacturing processes, from cell culture and gene editing to purification and formulation, ensuring adherence to regulatory standards and maintaining product quality and consistency. The incumbent collaborates closely with cross-functional teams, including research and development, MSAT, quality assurance, quality control, and client representatives, to drive efficient and compliant manufacturing operations.

The successful candidate 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:

* Leadership and Team Management:

* Provide strong leadership and direction to the manufacturing team, fostering a culture of innovation, collaboration, and excellence.

* Recruit, train, and develop staff, ensuring that team members possess the necessary skills and expertise to execute manufacturing processes effectively.

* Manufacturing Execution:

* Execute manufacturing processes according to established SOPs, batch records, and work instructions for the production of cell and gene therapy products.

* Perform tasks related to drug substance and drug product processing, including cell expansion, transfection, purification, formulation, and fill/finish operation.

* Prepare and operate equipment, such as bioreactors, centrifuges, chromatography systems, and filtration units, following safety and operational protocols.

* GMP Compliance:

* Oversee all manufacturing activities to ensure compliance with GMP regulations, FDA guidelines, and industry standards specific to cell and gene therapy.

* Adhere to robust quality systems, including batch record review, deviation management, and change control processes, to ensure regulatory compliance and product quality.

* Production Planning:

* Develop and execute production schedules to meet clinical trial and commercial supply requirements, while optimizing resource utilization and minimizing lead times.

* Monitor manufacturing processes closely, identifying and addressing deviations or issues that may impact product quality or production timelines.

* Technology Transfer and Scale-Up:

* Collaborate with MSAT teams to transfer new cell and gene therapy products from development to manufacturing, ensuring successful scale-up and process validation.

* Evaluate and implement new technologies, equipment, and manufacturing platforms to enhance production efficiency and capability.

* Continuous Improvement:

* Lead continuous improvement initiatives to optimize manufacturing processes, reduce costs, and enhance product quality and yield.

* Drive root cause analysis and CAPA activities to address deviations and non-conformances, ensuring continuous process improvement and compliance.

* Cross-Functional Collaboration:

* Collaborate with quality assurance, quality control, and other stakeholders to ensure timely resolution of quality issues, regulatory compliance, and successful regulatory inspections.

* Interface with external partners,…