Associate Director, Manufacturing

1 week ago

New Albany, Ohio, United States Amplifybio, LLC Full time

Are you enthusiastic about making a significant impact on the future of healthcare? Do you believe that a company's most valuable asset is its people? If so, come aboard AmplifyBio.

AmplifyBio is a top-tier research organization offering a wide range of services. We serve as an outsourcing partner for early-stage R&D activities, a preclinical CRO conducting safety, efficacy, and toxicology studies for both small molecules and advanced therapies, and we've recently expanded into manufacturing services for cell, gene, and mRNA-based treatments.

The AmplifyBio family includes three main business units: ADOC (South San Francisco, CA) – Amplify's Discovery, Optimization, and Characterization labs; ASET (West Jefferson, OH) – Amplify's Safety, Efficacy, and Toxicology Site; and the newly established AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.


About AMEC in New Albany, OH:

Amplify Bio's Manufacturing Enablement Center offers customizable cGMP suites for advanced therapy manufacturing using a unique 'hoteling model,' traditional CDMO, or a hybrid approach.

Collaborating with AmplifyBio for manufacturing cell therapy, gene therapy, mRNA, plasmid, or other modalities is a distinctive experience compared to standard CDMO services.

Our aim is to deliver flexible solutions tailored to each client's needs while ensuring a full expert partnership.

Amplify Bio is looking to hire a (Sr.) Manager/Associate Director of Manufacturing to join our expanding team.

The (Sr.) Manager/Associate Director of Manufacturing at AmplifyBio's AMEC Facility oversees the manufacturing operations within a GMP-compliant facility specializing in advanced therapies.

This position entails managing all manufacturing processes, from cell culture and gene editing to purification and formulation, to ensure regulatory compliance and product quality and consistency.

The incumbent works closely with various teams, including research and development, MSAT, quality assurance, quality control, and client representatives, to enhance efficient and compliant manufacturing operations.

The ideal candidate will play a vital role in maintaining the quality, compliance, and efficiency of manufacturing operations in the cutting-edge biotechnology field.



What You'll Be Doing Here:

Leadership and Team Management:

Offer strong leadership and guidance to the manufacturing team, promoting innovation, collaboration, and excellence.

Recruit, train, and develop staff, ensuring they have the required skills to execute manufacturing processes effectively.


Manufacturing Execution:

Perform manufacturing processes following established SOPs, batch records, and work instructions for producing cell and gene therapy products.

Tasks include drug substance and drug product processing, like cell expansion, transfection, purification, formulation, and fill/finish operations.

Operate equipment such as bioreactors, centrifuges, chromatography systems, and filtration units, adhering to safety and operational protocols.


GMP Compliance:

Supervise all manufacturing activities to ensure compliance with GMP regulations, FDA guidelines, and industry standards for cell and gene therapy.

Follow robust quality systems, including batch record review, deviation management, and change control processes, to guarantee regulatory compliance and product quality.


Production Planning:

Develop and implement production schedules to meet clinical trial and commercial supply needs, optimizing resource utilization and minimizing lead times.

Closely monitor manufacturing processes, 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 integrate new technologies, equipment, and manufacturing platforms to improve production efficiency and capability.


Continuous Improvement:
Lead initiatives for continuous improvement to optimize manufacturing processes, reduce costs, and enhance product quality and yield.

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


Cross-Functional Collaboration:

Work with quality assurance, quality control, and other stakeholders to promptly resolve quality issues, ensure regulatory compliance, and pass regulatory inspections successfully.

Engage with external partners, contract manufacturing organizations (CMOs), and vendors for technology transfer, raw material sourcing, and manufacturing outsourcing efforts.


Safety and Environmental Compliance:

Maintain a safe working environment for manufacturing staff by implementing safety protocols, training programs, and risk assessments.

Ensure compliance with environmental regulations and support sustainability initiatives in manufacturing operations.


If this sounds like your next career move, we'd love to hear from you. Here's what we're looking for:
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 position.

Deep knowledge of GMP regulations, FDA/EMA guidelines, and industry best practices for cell and gene therapy manufacturing.
Strong grasp of cell culture techniques, gene editing technologies, and aseptic processing.
Demonstrated leadership skills in team management, project management, and cross-functional collaboration.
Excellent communication and interpersonal abilities with the power to influence stakeholders at all levels.
Certification in GMP, such as ASQ Certified Pharmaceutical GMP Professional (CPGP), is a bonus.
AmplifyBio is committed to fostering an inclusive community within our organization, hiring and nurturing diverse teams from varied backgrounds and perspectives.AmplifyBio is an equal opportunity employer, valuing diversity in our workforce without discrimination based on various factors protected by law.
Why You'll Enjoy Working Here:

We prioritize the health and well-being of our employees and continually enhance our benefits to create a fantastic work environment.

From wellness programs to financial and legal assistance, we ensure our team is well taken care of.
Health, Dental, and Vision insurance starting on day one at Amplify Bio
Competitive Compensation Package
Unlimited PTO policy to support work-life balance
Generous paid parental leave
Wellness and Self-Care Programs
401(k) match
Tuition Reimbursement
EAP/work-life support system
A positive work environment where everyone's voice is valued.
We're only at the beginning with more benefits up ahead
An opportunity to make a difference in the world

Join us to be a part of pioneering work and collaborate with clients, research experts, study directors, lab technicians, and specialists across various fields.

At AmplifyBio, the future is shaped by our imagination and actions, and we hold ourselves to high standards in our decisions and outcomes.

We prioritize action, excellence, and, above all, the health and safety of our team members.

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