Drug Product Manufacturing Associate

Proclinical is partnering with a Drug Product Manufacturing Associate for a global pharmaceutical company located in Boulder, CO.

Job Responsibility:

• Support all aspects of drug product manufacturing operations at CMO's to manufacture clinical parenteral medicines according to approved protocols, regulations, and schedules.
• Partner with CMOs to accurately review and approve master batch records and executed batch records
• Support device development and implementation by supporting device engineers and regulatory experts
• Assist in managing change controls, quality events, investigations as needed.

Skills and Requirements:

• MS/PhD in Biochemistry/Microbiology/Chemistry/Engineering or related discipline and 5+ years in a cGMP setting preferred (or BS degree in similar field with 7+ years)
• In-depth experience in pharmaceutical operations associated with aseptic processing
• Understanding of engineering and process knowledge associated with various sterilization technologies, GMP utilities and associated pharmaceutical processes
• Understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems

If you are having difficulty in applying or if you have any questions, please contact Kelly Guerriero at (+1) 267-281-1277 or k.guerriero@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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