Manufacturing Supervisor - 2nd Shift

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

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…