Manufacturing Supervisor - 2nd Shift (3:00p-11:30p)

The Manufacturing Supervisor 2nd Shift is responsible for supporting and overseeing GMP manufacturing activities for development‑stage and commercial‑scale production of Active Pharmaceutical Ingredients (APIs). The role applies a broad knowledge of chemical processing, GMP principles, and operational leadership to ensure successful execution of Phase I–III and commercial manufacturing campaigns, technology transfers, and continuous operational readiness.

• Supervisory responsibilities for Process Technicians including performance management, coaching, and day‑to‑day oversight.
• Responsible for training new employees and developing existing team members to meet both development and commercial manufacturing expectations.
• Upholds a culture of safety, compliance, and operational discipline throughout manufacturing operations.
• Oversees execution of Batch Production Records (BPRs) under cGMP, ensuring all operational steps, quality checks, and in‑process controls are properly documented.
• Performs and/or reviews BPRs, SOPs, deviations, and batch summary reports for development and commercial campaigns.
• Ensures manufacturing readiness for commercial production, including equipment fit checks, raw material availability, and process control verification.
• Provides on‑floor oversight and decision‑making during critical operations such as charging, distillations, crystallization, filtration, drying, and packaging.
• Generates operational protocols and internal/external documentation including SOPs, BPRs, deviations, and summary reports for both clinical and commercial manufacturing.
• Partners with CRD Scientists, Engineering, and Manufacturing Chemists to transfer new and commercialized processes into GMP production.
• Supports implementation and maintenance of process control strategies to ensure robust and reproducible commercial‑scale operation.
• Troubleshoots process and equipment issues; works with Facilities and Engineering to maintain production equipment and recommend improvements or replacements.
• Supports proposals, feasibility assessments, and operational input related to commercial campaign planning.
• Interacts with clients during initial and subsequent manufacturing campaigns; may oversee and escort the Person‑in‑Plant (PIP) during GMP and commercial production.
• Works closely with the Director, Manufacturing to execute development and commercial manufacturing projects, ensuring timelines, quality standards, and contract objectives are met.
• Participates in internal and external audits, including client audits and regulatory inspections; prepares documentation and provides subject matter expertise as needed.
• Ensures operations align with GMP, ICH guidelines, and regulatory expectations for commercial operations (FDA, EMA, etc.).
• Supports initiation, investigation, and closure of deviations; may lead departmental investigations and manage related CAPAs.
• Supports scale‑up activities, including risk assessments (FMEA), process hazard analyses, and engineering studies.

• Commercial manufacturing experience, including late‑phase scale‑up, process validation, or PPQ execution.
• Ability to integrate information from diverse technical areas and independently develop creative operational solutions.
• Excellent verbal and written communication skills; strong interpersonal, problem‑solving, and organizational skills.
• Demonstrated ability to function effectively in a diverse team environment.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Exposure to broad analytical techniques and in‑process control strategies.
• Demonstrated leadership competencies: Leads with Integrity and Respect; Delivers Results; Demonstrates Business Acumen; Fosters Collaboration and Teamwork; Champions Change; Engages and Inspires; Coaches and Develops.

• HS Diploma or GED required, with 7–10 years’ experience in GMP production operations, including exposure to commercial or late‑phase manufacturing, OR
• Associates or Bachelors degree in a Scientific, Engineering or Biotech field with 4–7 years’ GMP manufacturing experience, OR
• Minimum 5 years’ leadership experience including performance management responsibilities.
• Strong documentation skills including drafting, reviewing, and executing Batch Production Records, SOPs, deviations, and summary reports.