Lead BioProcess Associate
About The Position
The Lead BioProcess Associate is a primarily leadership role supporting GMP manufacturing of bulk vaccines to meet site production schedules and goals. The role may support Central Services, Upstream, Downstream, or Final Formulation, and leads a team to ensure manufacturing operations are conducted safely and compliantly while production goals are met. The position reports to a Supervisor or Manager of Manufacturing. The role operates pharmaceutical manufacturing equipment, supports aseptic work, serves as a manufacturing subject matter expert and qualified trainer, and helps ensure adherence to GMP, safety, and site policies. It includes monitoring and performing critical processes, troubleshooting equipment and process issues, maintaining and reviewing manufacturing documentation, mentoring staff, maintaining cleanroom readiness, supporting equipment start-up and operation, and assisting with audits and regulatory inspections.
Requirements
- Bachelor’s degree in a Scientific, Engineering, or Biotech field, typically with 6 or more years of experience with biologic production processes under GMP compliance, or equivalent commensurate experience.
- Outstanding knowledge of and ability to apply scientific principles to solve operational and routine production tasks.
- Excellent documentation skills, including comprehension, review, and execution of Batch Production Records, SOPs, and forms.
- Meet applicable health and safety requirements, including adherence to job-related vaccination policies where consistent with applicable law.
Responsibilities
- Operate pharmaceutical manufacturing equipment, including autoclaves, parts washers, filter integrity testers, incubators, stainless-steel bioreactors, TFF skids, and in-process testing equipment.
- Work aseptically within a BioSafety Cabinet.
- Act as the manufacturing subject matter expert and qualified trainer for equipment and processes.
- Adhere to Emergent policies, GMP standards, and safety procedures.
- Ensure team members are properly gowned, follow available SOPs and BPRs, and use required PPE.
- Perform and monitor critical processes and execute routine validation protocols.
- Identify process anomalies or unexpected results in real time and report them to management.
- Identify and troubleshoot complex events involving manufacturing equipment and systems.
- Own document revisions and assist with executing and implementing change controls.
- Execute logbooks, forms, solution preparation, and batch records according to GMP and site quality standards.
- Coach and mentor junior staff in compliant quality documentation practices.
- Perform real-time review of BPRs, forms, and logbooks, and review logbooks, forms, solution records, and batch records according to GMP and site quality standards.
- Lead the team in cleaning and organizing the manufacturing cleanroom and ensure the area remains audit-ready.
- Support MSat, Engineering, and Facilities personnel with start-up, testing, and operation of manufacturing process equipment.
- Support Emergent QA during audits and regulatory inspections.
Benefits
- Comprehensive benefits package; further details are available through the company’s careers benefits information.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
