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Production Technician in Biopharmaceuticals

2 months ago

New Albany, Ohio, United States Amplifybio, LLC Full time
Join Our Team at AmplifyBio

Are you driven by the desire to enhance the future of healthcare? Do you recognize that the workforce is the cornerstone of any successful organization? If this resonates with you, consider a position with AmplifyBio.

AmplifyBio stands at the forefront of contract research organizations, offering a wide array of services that encompass everything from being a partner in discovery stage research and development to conducting preclinical studies focused on safety, efficacy, and toxicology for both small molecules and advanced therapies. Recently, we have expanded our capabilities to include manufacturing services for cell, gene, and mRNA-based therapeutics.

The AmplifyBio ecosystem is structured into three specialized 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 newly established AMEC (New Albany, OH) – Amplify's Manufacturing Enablement Center.

About AMEC New Albany, OH: The Manufacturing Enablement Center at AmplifyBio offers customizable cGMP suites designed to facilitate advanced therapy manufacturing through various models, including traditional contract development and manufacturing (CDMO) or a hybrid approach.

Partnering with AmplifyBio for the manufacturing of cell therapies, gene therapies, mRNA, plasmids, or other modalities provides a unique experience compared to conventional CDMO services. Our aim is to deliver tailored solutions that meet client needs while fostering a comprehensive expert partnership.

At AmplifyBio, drug developers will discover an innovation-driven ecosystem that supports a diverse range of pharmaceutical products throughout various development stages.

Position Overview: AmplifyBio is looking for a Manufacturing Technician (GMP) to become a vital part of our expanding team.

The Manufacturing Technician will be responsible for the execution of production processes within a GMP-compliant environment, specializing in the manufacturing of cell and gene therapies at AmplifyBio's Manufacturing Enablement Center (AMEC).

This role requires collaboration with senior manufacturing staff to ensure the effective production of therapeutic products while adhering to regulatory standards and quality requirements.

Key Responsibilities:

  • Manufacturing Execution: Carry out manufacturing processes following 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 operations.
  • Prepare and operate equipment such as bioreactors, centrifuges, chromatography systems, and filtration units, adhering to safety and operational protocols.

Documentation and Compliance:

  • Accurately complete manufacturing documentation in line with GMP regulations, including batch records, logbooks, and equipment usage logs.
  • Engage in the review and revision of manufacturing documents and procedures to ensure compliance with regulatory standards and continuous improvement.
  • Assist in investigating deviations, non-conformances, and CAPA activities, contributing to the resolution and prevention of quality incidents.

Quality Control and Assurance:

  • Conduct in-process testing and sampling to monitor critical quality attributes during manufacturing operations.
  • Support inventory management for raw materials, consumables, and reagents, ensuring availability for production activities.
  • Assist in equipment qualification, calibration, and maintenance to ensure reliability and compliance with regulatory standards.

Continuous Improvement:

  • Actively participate in initiatives aimed at enhancing manufacturing processes, efficiency, and product quality.
  • Provide feedback on process improvements and assist in implementing best practices to optimize operations.

Team Collaboration:

  • Work collaboratively with cross-functional teams, including manufacturing, quality assurance, quality control, and MSAT, to achieve production objectives.
  • Communicate effectively with supervisors and team members to ensure alignment on priorities and project timelines.

Qualifications:

  • Bachelor's or associate degree in biology, bioengineering, biotechnology, or a related field; or equivalent combination of education and experience.
  • Previous experience in a GMP manufacturing environment, particularly in cell and gene therapy or biopharmaceuticals, is preferred but not mandatory.
  • Demonstrated ability to perform operations in controlled aseptic environments.
  • Familiarity with GMP regulations and documentation practices is advantageous.
  • Strong attention to detail, organizational skills, and ability to adhere to standard operating procedures.
  • Excellent communication and interpersonal skills, with a collaborative approach to teamwork.
  • Flexibility to adapt to changing priorities and a willingness to work in a dynamic environment.
  • Ability to work independently with minimal supervision and show initiative in problem-solving.
  • Willingness to work flexible hours, including weekends and holidays, as needed to support manufacturing operations.

At AmplifyBio, we are dedicated to fostering an inclusive community within our organization and the industry at large. We value diversity and are committed to hiring and developing teams that reflect a wide range of backgrounds and experiences.

Why Join Us?

We prioritize the health and well-being of our employees and continuously seek new ways to enhance our benefits, creating an exceptional workplace.

  • Comprehensive health, dental, and vision insurance starting on your first day.
  • Competitive compensation package.
  • Commitment to work-life balance with an unlimited PTO policy.
  • Generous paid parental leave.
  • Wellness and self-care programs.
  • 401(k) matching.
  • Tuition reimbursement.
  • Employee assistance programs/work-life support.
  • A vibrant work environment where every voice is valued.

By joining our team, you will engage in groundbreaking work while collaborating with clients, research scientists, study directors, lab technicians, and specialists across various disciplines. The future of AmplifyBio is as promising as the synergy of our creativity and actions, and we hold ourselves accountable for our choices and outcomes.