Associate Director, Manufacturing - New Albany, United States - Amplifybio, LLC

Description

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 (Sr.) Manager/Associate Director of Manufacturing to join our growing team

The (Sr.) Manager/Associate Director, Maufacturing at AmplifyBio'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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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, contract manufacturing organizations (CMOs), and vendors to support technology transfer, raw material sourcing, and manufacturing outsourcing activities.
8. Safety and Environmental Compliance:
   • Maintain a safe working environment for manufacturing personnel by implementing and enforcing safety protocols, training programs, and risk assessments.
   • Ensure compliance with environmental regulations and promote sustainability initiatives within manufacturing operations.

We Would Love to Hear from You If:

• Bachelor's or advanced degree in biological sciences, bioengineering, or related field.
• Minimum of 5 years of experience in cell and/or gene therapy manufacturing, with at least 2 years in a leadership or managerial role.
• In-depth knowledge of GMP regulations, FDA/EMA guidelines, and industry best practices specific to cell and gene therapy manufacturing.
• Strong understanding of cell culture techniques, gene editing technologies, and aseptic processing.
• Demonstrated leadership abilities, including team management, project management, and cross-functional collaboration.
• Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels.
• Certification in GMP, such as ASQ Certified Pharmaceutical GMP Professional (CPGP), is a plus.

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.

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