Biopharm Manufacturing Assoc - Rockville Level 2 US Job Responsibilities
Education & Qualifications
- 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
- 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 - Bio-pharmaceutical 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
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.