Manufacturing Supervisor (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 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 a Manufacturing Supervisor (GMP) to join our growing team!!!

The Manufacturing Supervisor at AmplifyBio’s Manufacturing Enablement Center (AMEC) Facility is responsible for supervising the manufacturing operations within a GMP-compliant facility specializing in advanced therapies. This role involves overseeing a small team of associates executing various aspects of manufacturing, from cell culture and gene editing to purification and formulation, ensuring adherence to regulatory standards and maintaining product quality and consistency.

The successful candidate will play a crucial role in supervising and coordinating manufacturing operations to support the development and production of advanced therapies within a GMP-compliant manufacturing environment.

What You’ll Do Here:

1. 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.
2. Team Leadership and Management:
   • Provide leadership and guidance to the manufacturing team, fostering a culture of teamwork, collaboration, and excellence.
   • Supervise and coordinate the activities of manufacturing personnel, ensuring adherence to standard operating procedures (SOPs) and safety protocols.
3. GMP Compliance:
   • Ensure that manufacturing activities comply with GMP regulations, FDA guidelines, and industry standards specific to cell and gene therapy.
   • Participate in quality systems activities, including batch record review, deviation management, and change control processes, to maintain regulatory compliance and product quality.
4. Production Planning and Coordination:
   • Assist in the development and coordination of production schedules to meet clinical trial and commercial supply requirements, while optimizing resource utilization and minimizing lead times.
   • Collaborate with cross-functional teams to coordinate material availability, equipment readiness, and personnel allocation for efficient production operations.
5. Process Improvement and Troubleshooting:
   • Identify opportunities for process improvements to optimize manufacturing efficiency, reduce costs, and enhance product quality and yield.
   • Investigate and troubleshoot manufacturing deviations or issues, implementing corrective and preventive actions as necessary to ensure continuous process improvement.
6. Training and Development:
   • Provide training and support to manufacturing personnel, ensuring that team members possess the necessary skills and knowledge to perform their roles effectively.
   • Facilitate ongoing training and development opportunities to enhance the capabilities and competencies of the manufacturing team.
7. Safety and Environmental Compliance:
   • Promote a culture of safety awareness and environmental responsibility within the manufacturing environment, ensuring compliance with safety regulations and environmental policies.
   • Implement and enforce safety protocols, procedures, and training programs to maintain a safe working environment for manufacturing personnel.

We Would Love to Hear from You If:

• Bachelor's degree or equivalent experience.
• Minimum of 3-5 years of experience in cell and/or gene therapy manufacturing or a related biopharmaceutical manufacturing field.
• Knowledge of GMP regulations, FDA/EMA guidelines, and industry best practices relevant to cell and gene therapy manufacturing.
• Strong leadership and supervisory skills, with the ability to effectively manage and motivate a diverse team.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Attention to detail and problem-solving abilities, with a focus on ensuring compliance, quality, and efficiency in manufacturing operations.

At AmplifyBio, we're committed to growing and empowering an inclusive community within our company and industry. Therefore, we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization.

AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don't discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law.

Why You Will Love Working Here:

We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program to financial planning and legal assistance, we make sure to take care of our own.

• Health, Dental, and Vision insurance that starts on your first day at AmplifyBio!
• Competitive Compensation Package
• We take work-life balance seriously and we back it up with a UNLIMITED PTO policy.
• Generous paid parental leave
• Wellness and Self-Care Programs
• 401(k) match
• Tuition Reimbursement
• EAP/work-life support system
• A fun work environment where everyone’s voice matters.
• We are just getting started! More benefits on the way!
• An Opportunity to Change the World!!!

When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians, and specialists across a variety of disciplines. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.