• BS/BA or Associates Degree, Degree in other discipline (or lack of degree) may be considered if sufficient technical depth has been achieved from professional experience
• 5+years prior manufacturing experience in the biopharmaceutical industry
• Large Scale Purification experience preferred
• Experience working in a large scale cGMP Purification Manufacturing.
• Bachelor's Degree
• At least 3 years of experience leading the purification process
• 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.
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 Lead Manufacturing Associate. The Lead Manufacturing Associate 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. Will be responsible for completing daily manufacturing tasks as well as supporting more in-depth, long-term projects.
Key Responsibilities include the following:
• Operation of Bioprocess Equipment under strict adherence to and enforce cGMP, OSHA and polices and regulations, or others as required.
• Strong problem-solving and troubleshooting skills as demonstrated by a consistent track record of solutions to technical problems within large scale cGMP Purification Manufacturing.
• Ability to perform the following operations: CIP, SIP, SOP, cGMP, Tangential Flow Filtration, UF/DF, Chromatography columns, Column packing, A280 Spectrophotometry, ,Virus filtration, Depth Filtration, Bulk Filtration, Aseptic technique, and, Filter integrity testing.
• Monitors critical process parameters
• Draft and revise SOPs and Batch Records as necessary
• Documenting all manufacturing activities clearly and accurately.
• Trains new and less experienced team members.
• Conduct relevant process, cGMP and safety training
• Effectively troubleshoot equipment and processing problems
• Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
• Maintains a high level of mechanical and technical aptitude and training.
• 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.
• Lead resolution of technical and process problems, initiate change control for equipment/process modifications
• Lead closure of process deviations, investigations and corrective actions
• Lead new production projects, develop commissioning plans and author commissioning documents
• Member/Lead of project teams for technical transfer or new product scale-up
• Work on problems of advanced scope where analysis of situation or data requires a review of identifiable and unknown factors
• Identify, develop and implement process improvements, equipment improvements/upgrades
• Monitor and audit work processes to ensure compliance and completion of targets
• Will work with some hazardous materials under the appropriate safety procedures
• Receive, stage and track materials
• In conjunction with Supervisor, insure completion of daily operations
• Maintain at least a 95% cGMP training proficiency to ensure compliance
You may apply for this position online by selecting the Apply now button.
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