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

Cambrex•High Point, NC

8d•Onsite

About The Position

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.

Requirements

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.
Active work involving exertion of up to 40 pounds of force occasionally and routine lifting, carrying, pushing, or pulling.
Work is primarily performed in a production setting requiring regular standing, walking, and manual operations.
Use of ladders and roof access may be required.
Requires visual acuity, talking, hearing, and use of hands/fingers.
Work occurs in a chemical manufacturing environment.
Regular use of basic PPE including supplied‑air respirators, negative‑pressure respirators, gloves, safety glasses, and protective clothing.
Basic hazards associated with a chemical plant environment such as flammables and/or toxic materials, heavy item movement, large machinery operation.
Exposure to chemical vapors, solvents, elevated temperatures, and typical chemical processing conditions.

Responsibilities

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.