BioProcess Associate
About The Position
The Bioprocess Associate supports GMP manufacturing processes that may include Central Services, Upstream, Downstream, or Final Formulation. The role requires experience in GMP manufacturing, including operating GMP process equipment and maintaining GMP-compliant documentation. It reports to the Supervisor/Manager Manufacturing. The associate operates pharmaceutical manufacturing equipment, works aseptically within a BioSafety Cabinet, follows company policies and GMP and safety procedures, and carries out production documentation. The role also includes cleaning and organizing manufacturing cleanrooms, keeping areas audit-ready, supporting audits and regulatory inspections, and helping other manufacturing teams and cross-functional partners meet team goals. Duties may be reassigned by management. The company states that employees in this role must meet applicable health and safety requirements, including vaccination policies where job-related and lawful. Reasonable accommodation requests will be evaluated in accordance with applicable laws.
Requirements
- Bachelor’s degree in a scientific, engineering, or biotechnology field, typically with at least 2 years of experience with biologic production processes under GMP compliance, or equivalent commensurate experience.
- Knowledge of scientific principles and ability to apply them to operational and routine production tasks.
- Excellent documentation skills, including comprehension and execution of batch production records, SOPs, and forms.
- Ability to meet applicable health and safety requirements, including vaccination policies where job-related and consistent with applicable law.
Responsibilities
- Operate pharmaceutical manufacturing equipment, including autoclaves, parts washers, filter integrity testers, incubators, stainless steel bioreactors, centrifuges, TFF skids, and in-process testing equipment.
- Work aseptically within a BioSafety Cabinet.
- Follow Emergent policies, GMP standards, and safety procedures.
- Communicate the status of daily production tasks to team members and supervisors.
- Complete logbooks, forms, solution-preparation records, and batch records according to GMP and site quality standards.
- Assist with revisions to GMP documentation when needed.
- Clean and organize manufacturing cleanrooms and keep areas audit-ready.
- Support Emergent QA during audits and regulatory inspections.
- Support other manufacturing process teams and cross-functional partners as needed to achieve manufacturing team goals.
Benefits
- Comprehensive benefits package; details are available on the company careers website and eligibility is governed by applicable plan documents and policies.
- Certain roles are eligible for additional incentive compensation, including merit increases, annual bonuses, and/or long-term incentives in the form of stock options.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
