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Role Summary
Production Supervisor. This role leads and supports manufacturing operations in a fast-paced, collaborative environment. You will oversee daily production activities, ensure compliance with quality and safety standards, and drive continuous improvement initiatives. You will supervise Manufacturing Associates, participate in technology transfer readiness activities, and manage training and development of staff. This is a nightshift supporting role with off-shift hours including nights and a 10% shift differential.
Responsibilities
- Perform production activities alongside Manufacturing Associates and manage absences and timesheets as needed.
- Ensure compliance with Data Integrity principles, site SOPs, EHS standards, and relevant legal requirements.
- Oversee and review documentation to ensure bulk biopharmaceutical intermediates meet regulatory standards.
- Attend daily meetings or delegate to adjust the production schedule as necessary.
- Support the implementation of new products and processes, including equipment and area changeovers.
- Maintain competency with digital platforms (SAP, EBR, DeltaV, RTMS, etc.).
- Develop area expertise, participate in inspections, address technical issues, and manage team deliverables.
- Assign work to Manufacturing Associates to meet production schedules and optimize resources.
- Document development and performance management activities to support growth and engagement objectives.
- Collaborate with cross-functional teams to ensure safe and high-quality results.
- Adhere to Leader Standard Work to maintain visibility and support in the manufacturing area.
Qualifications
- Required: Associate’s degree in engineering, biology, or chemistry-related discipline.
- Required: 2+ years of experience in a production environment (e.g., cell culture, microbial fermentation, buffer preparation, purification).
- Required: Understanding of GMP and regulatory requirements.
- Required: Ability to work a 5pm–5am shift, including every other weekend.
- Preferred: Bachelor’s degree in engineering, biology, chemistry, or related technical discipline.
- Preferred: 1+ year of supervisory/leadership experience.
- Preferred: Strong teamwork, communication, and organizational skills; experience with SAP, MES, or similar systems; familiarity with control systems in biopharma manufacturing.
Skills
- Leadership and people management
- Continuous improvement and problem-solving
- Project and production scheduling
- Technical troubleshooting and cross-functional collaboration
- Effective communication and documentation
Education
- Associate’s degree required; Bachelor’s degree preferred.
Additional Requirements
- On-site role requiring hands-on involvement in production areas.
- Night shift with 10% differential.