Alphanumeric is hiring a BIOPHARM MANUFACTURING ASSOCIATE to work in Rockville, MD with one of the largest pharmaceutical companies in the world.
Under the direction of senior personnel, 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.
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 Performs other functions as necessary or as assigned.
Maintain at least an 95% cGMP training proficiency to ensure compliance
Minimum Level of Education - BS/BA or Associates Degree with 2-4 or more years of directly related experience.
Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience - Biopharmaceutical processes are acknowledged to be more complex than chemical or pharmaceutical processes.
Besides normal processing, multiple validation studies, scale up activities, and other trouble shooting activities may also be occurring 2-4 years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance Understanding of the basic FDA cGMP regulations - Biopharmaceutical processes are acknowledged to be more complex than chemical or pharmaceutical processes
Biopharmaceutical processes are held to tight, critical specifications in which one minor change can affect the overall yield and/or quality of the product
Strong verbal and written skills.
Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
Ability to work a shift that covers a 24/7 operation
Ability to lift and carry materials weighing as much as 50lbs.