Manufacturing Associate II-III (Support Services)
AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, on time. For more information, visit www.agcbio.com.
SUMMARY:
The Manufacturing Associate II-III (Support Services) is responsible for overseeing the cleaning and gowning contractors in a large scale GMP manufacturing facility.
PRINCIPAL RESPONSIBILITIES:
- Daily organization of cleaning service provider staff, including but not limited to scheduling, training, auditing, and GMP documentation review.
- Oversee cleaning contractors during night shift.
- Recognize and escalate to AGC manufacturing management potential or ongoing personnel issues.
- Ensure cleaning supplies are maintained and available at all times.
- Coordinate emergency or remediation cleanings as necessary.
- Ensure gowning materials and supplies are available and stocked in each production area at all times.
- Establish, maintain, and continuously improve GMP procedures for cleaning program and gowning program.
- Collaborate cross-functionally with QA and Micro to support Environmental Monitoring and respond appropriately to environmental trends and excursions.
- Promote a safe work environment.
- Provide status updates to Leadership team.
- Participate in cross-functional meetings, customer meetings, audits etc.
- Coordinate and work with teams to ensure all responsibilities are assigned and executed as required.
- Act as backup AGC contact with cleaning service and gowning service providers.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Must be able to communicate clearly in English, both verbally and written. Fluency in Spanish is preferred.
- Thorough knowledge of GMP regulations as it applies to job function.
- Technical writing skills preferred.
- Strong organization skills with the ability to prioritize tasks for service contractors.
- Ability to interact constructively with peers, support groups, and service contractors.
- Ability to off shift hours to support production and / or maintenance activities.
- Ability to lift up to 40 lbs. with assistance.
- Ability to work in confined spaces and near operating equipment.
- Ability to work in loud noise environments.
EDUCATION/EXPERIENCE:
- BS in Chemistry, Biology or other relevant discipline.
- Depending on level, 2-5+ years' GMP operations experience, including leading a team/group. Compensation is commensurate with experience.
- Equivalent education and experience may substitute for stated requirements.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.