The Manufacturing Supervisor is responsible for leading GMP manufacturing operations supporting biologics production, including cell culture, fermentation, harvest, purification, and bulk drug substance manufacturing activities. This role provides direct supervision of manufacturing personnel, ensures compliance with current Good Manufacturing Practices (cGMP), and drives safe, efficient, and high-quality execution of manufacturing campaigns.

The supervisor serves as a key operational leader, coordinating production activities, managing shift resources, supporting technology transfer and process validation activities, and partnering with Quality, Process Sciences, Supply Chain, Facilities, and MSAT teams to achieve production objectives. This role will be dedicated to the 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

Manufacturing Operations Leadership

1. Supervise day-to-day upstream and downstream GMP manufacturing operations.
2. Lead production activities including media and buffer preparation, cell culture expansion, bioreactor operations, harvest, chromatography, ultrafiltration/diafiltration (UF/DF), and bulk filling activities.
3. Ensure manufacturing campaigns are executed according to approved batch records, SOPs, and manufacturing schedules.
4. Coordinate shift activities and allocate resources to meet production requirements.
5. Monitor manufacturing performance and address operational challenges in real time.
6. Drive adherence to production schedules while maintaining quality and compliance standards.

Team Leadership & Development

1. Supervise, coach, mentor, and develop Manufacturing Associates and Senior Manufacturing Associates.
2. Conduct performance evaluations and establish development plans for team members.
3. Facilitate onboarding and qualification of new employees.
4. Promote a culture of safety, teamwork, accountability, and continuous improvement.
5. Lead daily shift meetings, production reviews, and operational communications.

GMP Compliance & Quality

1. Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements.
2. Review and verify batch documentation for accuracy and completeness.
3. Support investigations, deviations, CAPAs, change controls, and quality events.
4. Participate in internal audits, client audits, and regulatory inspections.
5. Ensure proper documentation practices and data integrity standards are maintained.

Process Execution & Technical Support

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

Safety & Operational Excellence

1. Champion Environmental Health and Safety (EHS) compliance.
2. Ensure safe handling of biological materials, chemicals, and manufacturing equipment.
3. Lead risk assessments and support implementation of corrective actions.
4. Drive Lean Manufacturing and continuous improvement initiatives.
5. Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.

Cross-Functional Collaboration

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

Qualifications

Education
1. Bachelor's degree in Biotechnology, Biochemistry, Biology, Chemical Engineering, Bioprocess Engineering, or related scientific discipline. (Master's degree preferred)

Experience
1. 5-8 years of experience in biopharmaceutical manufacturing within a GMP-regulated environment.
2. Minimum 2 years of leadership or supervisory experience.
3. Hands-on experience with both upstream and downstream biologics manufacturing operations.
4. Experience supporting commercial, late-stage clinical, or process validation manufacturing campaigns.

Technical Knowledge (Preferred)
1. Mammalian cell culture and/or microbial fermentation operations.
2. Single-use bioreactor systems.
3. Chromatography systems (ÄKTA or equivalent).
4. Tangential Flow Filtration (TFF), UF/DF operations.
5. Media and buffer preparation.
6. GMP documentation practices.
7. Electronic systems such as MES, Veeva, TrackWise, DeltaV, SAP, or equivalent platforms.
8. Familiarity with FDA, EMA, MHRA, and ICH GMP requirements.

Qualifications (Preferred)
1. Experience in CDMO manufacturing environments.
2. Prior involvement with technology transfer and scale-up activities.
3. Lean Six Sigma certification or continuous improvement experience.
4. Experience managing multiple manufacturing campaigns simultaneously.
5. Knowledge of monoclonal antibody and recombinant protein manufacturing processes.

Core Competencies
1. Leadership and people development
2. GMP compliance and inspection readiness
3. Technical problem-solving
4. Decision-making and accountability
5. Operational planning and execution
6. Communication and collaboration
7. Continuous improvement mindset
8. Customer focus
9. Safety leadership

$100,000 - $120,000 a year

FLSA: Exempt