Lead BioProcess Associate
About The Position
Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives. The Lead Bioprocess Associate position reports to Supervisor/Manager Manufacturing. The Lead Bioprocess Associate is primarily a leadership role in the context of the production of bulk vaccines to meet the production schedule and goals of the site. This role is responsible for supporting the overall GMP manufacturing process that may include Central Services, Upstream, Downstream, or Final Formulation. Responsible leading the team to ensure operations are performed in a safe and compliant manner while ensuring production goals are met.
Requirements
- Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company’s vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
- Bachelor’s degree in a Scientific, Engineering or Biotech field typically with 6+ years’ experience with biologic production processes under GMP compliance or equivalent commensurate experience.
- Outstanding knowledge, and ability to apply scientific principles utilized to solve operational, as well as routine production tasks
- Excellent documentation skills including comprehension, review & execution of Batch Production Records, SOP’s and forms.
Responsibilities
- Operates pharmaceutical manufacturing equipment such as autoclaves, parts washers, filter integrity testers, incubators, stainless-steel bioreactors, TFF skids, and in process testing equipment. Ability to operate in an aseptic manner within a BioSafety Cabinet.
- Act as the manufacturing SME and qualified trainer for equipment and processes.
- Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures.
- Ensure the team in work area is properly gowned, SOPs/BPRs are out and being followed, PPE is being used as required.
- Perform and monitor critical processes, execute routine validation protocols. In real time identify process anomalies or unexpected results and report to management.
- Identify and troubleshoot complex events on equipment and systems used in Manufacturing.
- Own document revisions and assist in the execution and implementation of change controls.
- Executes logbooks, forms, solution prep and batch records according to GMP and site quality standards. Coach and mentor more junior staff to ensure compliant execution of quality documentation.
- Perform real time review of BPRs, forms and logbooks.
- Review logbooks, forms, solution and batch records according to GMP and site quality standards.
- Leads the team to ensure propre cleaning and organization of the manufacturing cleanroom. Ensures the area is audit ready at all times.
- Supports MSat, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment.
- Supports Emergent QA during audits and regulatory inspections.
Benefits
- Eligibility for benefits is governed by the applicable plan documents and policies.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
