Manufacturing Support Technician (GMP) at AmplifyBio

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 Support Technician (GMP) to join our growing team!!!

The Manufacturing Support Technician is responsible for assisting manufacturing 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 Support Technician for Cell and Gene Therapies 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:

Cleaning & Sanitation:

• Perform routine and deep cleaning of manufacturing areas, including floors, walls, equipment, and other surfaces, ensuring all cleaning activities meet GMP standards.
• Clean and sanitize production equipment and other tools according to SOPs and cleaning schedules.
• Ensure that all cleaning agents and sanitizers are used correctly, stored properly, and within expiration dates.
• Document all cleaning activities in logbooks and other required records, ensuring accuracy and compliance.

Documentation and Compliance:

• Complete manufacturing documentation accurately and in accordance with GMP regulations, including batch records, logbooks, and equipment usage logs. Adhere to all GMP guidelines and SOPs related to cleaning and sanitation.
• Participate in regular GMP trainings to stay up-to-date with industry standards and company policies.
• Report any deviations, non-conformances, or issues related to cleaning activities to the Management. Assist with internal audits and inspections related to cleanliness and GMP compliance.

Team Collaboration:

• Work collaboratively with manufacturing, quality assurance, quality control and other departments to ensure a coordinated approach to cleaning and sanitation.
• Support cross-functional teams with cleaning-related tasks during product changeovers, shutdowns, or other critical operations.
• Provide input on improvements to cleaning procedures and practices.

Inventory Management:

• Monitor and maintain inventory levels of cleaning supplies, PPE, and other materials required for cleaning tasks.

Safety & Hazard Management:

• Follow all safety protocols while performing cleaning tasks, including the use of personal protective equipment (PPE).
• Identify and report potential safety hazards within the cleaning areas.

We Would Love to Hear from You If:

• Highschool diploma required. Associate degree in biology, bioengineering, biotechnology, or related field preferred or equivalent combination of education and experience.
• Previous experience in a GMP regulated environment preferably in cell and gene therapy or biopharmaceuticals, is desirable but not required.
• Ability to work in a cleanroom environment with strict hygiene standards and ability to wear job specific clean room PPE for extended periods of time.
• 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 an FLEXIBLE 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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