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Cambrex

Global CDMO for drug substances

Manufacturing Technician - Drug Substance Manufacturing

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeLongmont, CO, USAIn-person

About the Job

Requirements

  • Have a basic understanding of current Good Manufacturing Practice and Good Documentation Practice requirements for drug substance manufacturing operations.
  • Be able to apply learned knowledge of equipment and facility maintenance for GMP and non-GMP production areas; good mechanical aptitude is preferred.
  • Have basic to intermediate knowledge of manufacturing equipment operations, including batch reactors, filters, dryers, and pumps, as well as handling glass laboratory equipment.
  • Have basic chemical processing skills, including weighing, calculations, GMP documentation, vacuum, pressure, and filtration techniques.
  • Be able to wear respirators and various types of personal protective equipment while promoting a safe work environment.
  • Be able to read and comprehend detailed written instructions and provide feedback to ensure they are accurate and can be performed as written.
  • Adhere to the attendance policy; be punctual, reliable, and willing to work outside normal working hours as requested.
  • Be able to perform basic to intermediate mathematical calculations, including inventory reconciliation.
  • Be able to work independently or within a team environment with minimal supervision.
  • Show initiative and attention to detail, and perform tasks with minimal supervision.
  • Be able to troubleshoot and communicate potential roadblocks to management.
  • Have flexibility and time-management skills to perform other duties as assigned without hindering obligations.
  • Have a high school diploma or equivalent with 6 months of experience in a regulated environment, or a BS in a technical field with relevant experience.
  • Successfully complete a comprehensive pre-employment screen, which may include a drug test, criminal-record check, identity verification, reference checks, and education and employment verification.
  • Be able to meet the role's physical demands, including regularly handling objects, standing, and lifting or moving items up to 50 pounds regularly, 60 pounds frequently, and 75 pounds occasionally; reasonable accommodations may be made.
  • Be able to work in an environment with moderate to noisy sound, occasional airborne particles, fumes, chemicals, moving mechanical parts, and vibration, and wear required personal protective equipment.

Responsibilities

  • Set up, operate, break down, and clean production equipment according to written procedures.
  • Maintain current Good Manufacturing Practice suites so they are tour- and audit-ready and prepared for manufacturing activities.
  • Independently perform basic to intermediate scale-up operations for drug substance in the assigned manufacturing area.
  • Understand and follow written procedures.
  • Document activities clearly and accurately in production records and manufacturing equipment records in accordance with ALCOA, GMP, and Good Documentation Practices.
  • Perform routine equipment maintenance and preventative maintenance; repair production equipment with guidance as needed.
  • Clean production suites, hoods, and equipment according to standard operating procedures using good chemical hygiene practices.
  • Work with or around hazardous waste and receive and maintain annual Resource Conservation and Recovery Act training.
  • Identify and stock equipment and parts as needed for manufacturing processes.
  • Troubleshoot issues and communicate potential roadblocks to management.

Desired Qualifications

  • Good mechanical aptitude.
  • Six months of experience in a regulated environment.

About the Company

Cambrex

Global CDMO for drug substances

Cambrex is a global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, plus analytical and IND enabling services. It uses a range of specialized technologies—such as continuous flow chemistry, handling of controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and production of highly potent APIs—to develop and manufacture drug substances for clients. The company differentiates itself with over 40 years of experience, a staff of about 2,000 experts, and a global footprint in North America and Europe, offering end-to-end capabilities from early development through commercial-scale manufacturing. Its goal is to help clients bring new medicines to market by delivering integrated, reliable drug substance development and manufacturing and related analytical support.

Company size
1,001-5,000
Company stage
IPO
Headquarters
East Rutherford, NJ
Founded
1981

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