Manufacturing Associate - 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 Manufacturing Associate (GMP) to join our growing team

The Manufacturing Associate is responsible for execution of manufacturing processes within a GMP-compliant facility specializing in cell and gene therapy production at AmplifyBio's Manufacturing Enablement Center (AMEC) Facility. This role involves working under the supervision of senior manufacturing personnel to ensure the successful production of therapeutic products while maintaining compliance with regulatory standards and quality requirements.

The Manufacturing Associate will play an essential role in supporting manufacturing operations, ensuring compliance with regulatory standards, and contributing to the advancement of cell and gene therapy products for patient treatment.

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. Documentation and Compliance:
   • Complete manufacturing documentation accurately and in accordance with GMP regulations, including batch records, logbooks, and equipment usage logs.
   • Participate in the review and revision of manufacturing documents and procedures to ensure compliance with regulatory requirements and continuous process improvement.
   • Assist in investigations of deviations, non-conformances, and CAPA activities, contributing to the resolution and prevention of quality incidents.
3. Quality Control and Assurance:
   • Perform in-process testing and sampling to monitor critical quality attributes and parameters during manufacturing operations.
   • Assist in maintaining inventory levels for raw materials, consumables, and reagents, ensuring availability for manufacturing activities while adhering to inventory management procedures.
   • Support equipment qualification, calibration, and maintenance activities to ensure equipment reliability and compliance with regulatory standards.
4. Continuous Improvement:
   • Actively participate in continuous improvement initiatives to enhance manufacturing processes, efficiency, and product quality.
   • Provide feedback on process improvements and assist in the implementation of best practices to optimize manufacturing operations.
5. Team Collaboration:
   • Collaborate effectively with cross-functional teams, including manufacturing, quality assurance, quality control, and MSAT, to achieve production goals and resolve operational challenges.
   • Communicate clearly and proactively with supervisors and team members to ensure alignment on priorities, tasks, and project timelines.

We Would Love to Hear from You If:

• Bachelor's or associate degree in biology, bioengineering, biotechnology, or related field; or equivalent combination of education and experience.
• Previous experience in a GMP manufacturing environment, preferably in cell and gene therapy or biopharmaceuticals, is desirable but not required.
• Demonstrated ability to execute operations in controlled aseptic environments.
• Knowledge of GMP regulations and documentation practices is advantageous.
• Strong attention to detail, organizational skills, and ability to follow standard operating procedures.
• Excellent communication and interpersonal skills, with the ability to work collaboratively in a team-oriented environment.
• Flexibility to adapt to changing priorities and willingness to work in a dynamic and fast-paced environment.
• Ability to work independently with minimal supervision and demonstrate initiative in problem-solving and decision-making.
• Willingness to work flexible hours, including weekends and holidays, as needed to support 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.

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