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 development, execution, and documentation, to demonstrate the robustness and compliance of manufacturing processes.
   • Provide expertise and guidance on regulatory strategy for cell and gene therapy manufacturing, including preparation of regulatory submissions and participation in regulatory inspections.
6. Continuous Improvement:
   • Drive continuous improvement initiatives to optimize manufacturing processes, reduce costs, and increase efficiency while maintaining product quality and compliance with regulatory requirements.
   • Implement best practices and lessons learned from process development and manufacturing experience.
7. Leadership and Team Management:
   • Provide leadership, mentorship, and guidance to a team of scientists, engineers, and technical professionals within the MSAT organization.
   • Foster a culture of innovation, collaboration, and continuous learning to support the growth and development of the team.

We Would Love to Hear from You If:

• Bachelor's degree in biological sciences, bioengineering, or related field (advanced degree preferred).
• Minimum of 10 years of experience in cell and gene therapy manufacturing or related biopharmaceutical industry.
• Demonstrated leadership experience in leading cross-functional teams and managing complex projects.
• Strong understanding of regulatory requirements and guidelines for cell and gene therapy manufacturing (e.g., cGMP, FDA regulations).
• Excellent communication, problem-solving, and decision-making skills.
• Proven track record of driving process optimization, technology transfer, and continuous improvement initiatives.

Preferred Qualifications:

• Experience with cell and gene therapy tech transfer, scale-up, validation, and commercialization.
• Prior experience in a leadership role within MSAT or process development function.
• Knowledge of advanced manufacturing technologies and platforms for cell and gene therapy production.
• Experience with regulatory submissions and interactions with regulatory agencies.

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.

Location: New Albany, OH, US

Posted Date: 12/22/2024