BS/BA or Associates Degree with 3-6 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
3-6 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
• Strong verbal and written skills. Must be able to follow detailed processing instructions as well as accurately documenting all necessary documentation.
• Demonstrated ability to work effectively in a team
• Ability to work a shift that covers a 24/7 operation and work different/ rotating shifts.
• Strong documentation practices
Why GSK? Because GSK's Biopharm business vision is to leverage its experience and technical capabilities to launch, supply, and manage Biopharmaceutical products around the world. It will fulfill GSK's Mission to Do More, Feel Better, and Live Longer by living its values: Integrity: Always doing the right thing; Commitment to the Patient: Making the Patient the #1 Priority; Customer Service: Commit to delivering on promises to internal & external customers; Compliance - Being accountable for quality and safety.
GSK Biopharm in Rockville MD has an opening for a Sr Biopharm Manufacturing Associate. In this role, you will perform 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. You will be responsible for completing daily manufacturing tasks as well as supporting more in-depth, long term projects.
• Completing daily manufacturing tasks per standard operating procedures and batch document instructions.
• Monitors critical process parameters
• Documenting all manufacturing activities clearly and accurately.
• Monitor and audit work processes to ensure compliance and completion of goals.
• Trains new and less experienced team members.
• Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
• Assist with closure of process deviations, investigations and corrective actions
• Maintains a high level of mechanical and technical aptitude and training.
• Assist resolution of technical and process problems; Identify, develop and implement process improvements
• Works on problems of advanced scope where analysis of situation or data requires a review of identifiable factors, including process history.
• Identify process issues; collaborate with team and external departments to address best practices.
• During technical transfer and the start up activities, provide input on design and operation of equipment.
• Ensures all production activities are completed in a safe and compliant manor.
• Leads the production team as required in the absence of senior staff.
• Maintain at least 85% cGMP training to ensure compliance
• Perform CIP , FIT and SIP of product tanks
• Dispense large and small amounts of raw materials
• Will work with some hazardous materials under the appropriate safety procedures
• Receive, stage and track materials
• Maintain at least an 95% cGMP training proficiency to ensure compliance
• Able to work around heights, carry load up to 50lbs
• Able to support 24/7 operations that includes weekends and holidays
You may apply for this position online by selecting the Apply now button.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
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