Manufacturing Supervisor I - Shift B

Responsibilities

• Supervise day-to-day upstream and downstream GMP manufacturing operations.
• Lead production activities including media and buffer preparation, cell culture expansion, bioreactor operations, harvest, chromatography, ultrafiltration/diafiltration (UF/DF), and bulk filling activities.
• Ensure manufacturing campaigns are executed according to approved batch records, SOPs, and manufacturing schedules.
• Career Development: Supervise, coach, mentor, and develop Manufacturing Associates and Senior Manufacturing Associates. Conduct performance evaluations and establish development plans for team members. Facilitate onboarding and qualification of new employees. Promote a culture of safety, teamwork, accountability, and continuous improvement.
• Operational Excellence: Lead daily shift meetings, production reviews, and operational communications.

GMP Compliance & Quality

• 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.

Process Execution & Technical Support

• Provide technical oversight for upstream and downstream operations.
• Support process transfers from development to GMP manufacturing.
• Aid in process validation, engineering runs, and GMP campaign readiness activities.
• Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency.
• Troubleshoot manufacturing and equipment-related issues.

Safety & Operational Excellence

• 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.

Cross-Functional Collaboration

• Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams.
• Support customer visits and client-facing manufacturing discussions as required.
• Ensure manufacturing readiness through effective planning and material coordination.

Qualifications

• Bachelor's degree in Biotechnology, Biochemistry, Biology, Chemical Engineering, Bioprocess Engineering, or related scientific discipline. (Master's degree preferred)
• 5–8 years of experience in biopharmaceutical manufacturing within a GMP-regulated environment.
• Minimum 2 years of leadership or supervisory experience.
• Hands-on experience with both upstream and downstream biologics manufacturing operations.
• Experience supporting commercial, late-stage clinical, or process validation manufacturing campaigns.
• Mammalian cell culture and/or microbial fermentation operations.
• Single-use bioreactor systems.
• Chromatography systems (ÄKTA or equivalent).
• Tangential Flow Filtration (TFF), UF/DF operations.
• Media and buffer preparation.
• GMP documentation practices.
• Electronic systems such as MES, Veeva, TrackWise, DeltaV, SAP, or equivalent platforms.
• Familiarity with FDA, EMA, MHRA, and ICH GMP requirements.

Preferred Qualifications

• Experience in CDMO manufacturing environments.
• Prior involvement with technology transfer and scale-up activities.
• Leverage of Lean Six Sigma certification or continuous improvement experience.
• Experience managing multiple manufacturing campaigns simultaneously.
• Knowledge of monoclonal antibody and recombinant protein manufacturing processes.

Physical Requirements

• Ability to sit or stand for extended periods of time.
• Frequently lift and or move objects at least 50 pounds in weight.
• Stand/walk during the entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities include near and far sight, color, peripheral vision, depth and ability to focus.

Benefits

$100,000 - $120,000 a year

Schedule

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