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Manufacturing Operations Technician

2 months ago

New Albany, Ohio, United States AmplifyBio Full time
About the Role

We are seeking a highly motivated and detail-oriented Manufacturing Support Technician to join our team at AmplifyBio. As a key member of our manufacturing operations team, you will play a critical role in ensuring the successful production of therapeutic products while maintaining compliance with regulatory standards and quality requirements.

Key Responsibilities
  • Cleaning and Sanitation: Perform routine and deep cleaning of manufacturing areas, including floors, walls, equipment, and other surfaces, ensuring all cleaning activities meet GMP standards.
  • 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.
  • Team Collaboration: Work collaboratively with manufacturing, quality assurance, quality control, and other departments to ensure a coordinated approach to cleaning and sanitation.
  • Inventory Management: Monitor and maintain inventory levels of cleaning supplies, PPE, and other materials required for cleaning tasks.
  • Safety and 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.
Requirements
  • High school 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 cleanroom 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.
About 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.

Our 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.

We are 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.