Contract position: A Biopharmaceutical Manufacturing Associate is needed for a leading pharmaceutical manufacturer in the Rockville, MD area. This role performs production operations including fermentation or cell culture operations, preparation of media and buffer solutions, chromatographic separation, filtration and concentration operation, etc as well as being involved in both start-up and product changeover activities. No per diem. Ability to a 12 hour work shift that covers a 24/7 operation required. Must be willing to work any shift, holidays, and weekends.Responsibilities for the Specialist
Requirements for the Specialist
- Completing daily manufacturing tasks per standard operating procedures and batch document instructions. Monitors critical process parameters Documenting all manufacturing activities clearly and accurately.
- Ensures all processing equipment and materials necessary are adequate and available to set the team up for success. Ensures all production activities are completed in a safe and compliant manor.
- Maintain and prepare high quality documentation. Dispense large and small amounts of raw materials Perform CIP and SIP of product tanks Work with hazardous materials under the appropriate safety procedures
- BS/BA or Associates Degree or sufficient manufacturing experience in the pharmaceutical or biotechnology industry preferred.
- Understanding of the basic FDA cGMP regulations. Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.