Sr Manufacturing Associate - Shift B
AbzenaAbout the role
The Senior Manufacturing Operator is responsible for executing complex GMP manufacturing operations supporting biologics production in a single-use manufacturing facility. This role performs advanced upstream and downstream processing activities, serves as a technical resource, supports training activities, assists with troubleshooting, and contributes to continuous improvement while maintaining compliance with cGMP requirements.
The Senior Manufacturing Operator will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.
Example Plan Shifts/Training Schedule:
- First 2 weeks: 8 hour shifts, M-F
- Next 1-2 months: 10 hour shifts, Mon-Thurs
- After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays
Schedule is subject to change based on needs.
Responsibilities
- Execute upstream and downstream GMP manufacturing activities according to approved batch records and SOPs.
- Perform cell thaw, inoculum expansion, bioreactor, harvest, purification, filtration, and bulk drug substance operations.
- Set up, operate, monitor, and maintain manufacturing equipment and single-use processing systems.
- Perform aseptic operations in cleanroom environments.
- Support validation, engineering, and GMP manufacturing campaigns.
- Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling.
- Ensure activities are performed according to approved batch records, SOPs, and production schedules.
- Provide hands-on training and qualification support for manufacturing personnel.
- Review GMP documentation for completeness, accuracy, and compliance.
- Support deviations, CAPAs, change controls, and quality events.
- Troubleshoot process, equipment, and operational issues.
- Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management.
- Train Manufacturing Associates.
- Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements.
- Review and verify batch documentation for accuracy and completeness.
- Support investigations, deviations, CAPAs, change controls, and quality events.
- Participate in internal audits, client audits, and regulatory inspections.
- Ensure proper documentation practices and data integrity standards are maintained.
- Serve as a technical resource for manufacturing equipment and processes.
- Assist with training and qualification of Manufacturing Operators.
- Provide guidance on GMP documentation and aseptic technique.
- Support onboarding and development activities.
- Champion Environmental Health and Safety (EHS) compliance.
- Ensure safe handling of biological materials, chemicals, and manufacturing equipment.
- Lead risk assessments and support implementation of corrective actions.
- Drive Lean Manufacturing and continuous improvement initiatives.
- Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.
Manufacturing Operations Individual Skills
GMP Compliance & Quality
Process Execution & Technical Support
Safety & Operational Excellence
Qualifications
- BA/BS degree that included laboratory work in a chemistry, biology, or related field.
- At least 2 – years of purification experience in a GMP pharmaceutical/biotech environment role.
- Demonstrate knowledge and understanding
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