Company Information
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.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
engage in work that matters to our customers and the patients they serve
learn new skills and enjoy new experiences in an engaging and safe environment
strengthen connections with coworkers and the community
We're committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!
Your Future Matters.
Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!
Job Overview
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.
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 replace ments.
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.
Qualifications/Skills
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.
Education, Experience & Licensing Requirements
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.
Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.
