Location(s): United States; Massachusetts; Marlborough
About Us: GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry. GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: The Cleanroom Associate Group Leader is responsible for performing and leading Manufacturing operations according to standard operating procedures and batch instructions as well as provide daily leadership to the Operators on the night shift.
Essential Responsibilities: • Be the shift lead, providing instruction to the team. Leadership responsibilities include managing daily scheduled work in their assigned area, performance assessments and providing feedback. • Demonstrate effective written and verbal communication skills and provides instruction to others when required • Supports operation of cGMP Biomanufacturing equipment, including; o pH/conductivity meters, single use mixing tanks (XDM’s), tubing fusers/sealers, filter integrity testers, cell counters, metabolite analyzers, peristaltic pumps, balances and biosafety cabinets (BSC). • Training on cGMP manufacturing operations, which include but are not limited to the following; operation and monitoring of cell culture and/or purification equipment, media and solution preparation & writing, reviewing and revising of cGMP documentation. • Ensure process equipment is appropriately maintained for operation; Troubleshoot equipment issues, when necessary • Supports Cell Culture and/or Protein Purification operations in a cleanroom environment, including; o Incubators, Wave Reactors, Single Use Bioreactors (XDR) o Chromatography skids, Depth Filtration, Viral Filtration and Tangential Flow Filtration • Monitor the flow of daily production activities and adjust workload and resources in an appropriate, organized and efficient manner • Recognize and initiates process deviations, perform investigations and support closure of quality systems • Monitor and escalate discrepancies with QA and EHS procedures and policies as required • Perform Manufacturing review and approval of all documents • Responsible for all aspects of the manufacture of bio-therapeutic molecules at various scales • Assist with recruiting, interviewing and hiring of new personnel as needed • Responsible for the training of new and experienced technicians in all aspects of bridge manufacturing operations. • Assist in development and execution of equipment qualification and validation protocols • Routinely originate and revise standard operating procedures, master production records and buffer prep records • Demonstrate an ability to multi-task and manage multiple projects independently • Maintain a safe work environment for self and staff • Subject matter expert of operations within assigned area
Quality Specific Goals: • Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Aware of and comply with Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position • Training: Aware of and comply with GEHC training requirements
Qualifications/Requirements: • Ability to communicate expectations and hold team accountable to all production, safety and quality requirements • Minimum of 5 years’ experience in biomanufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements • Available to work the Night Shit; Monday – Friday, 8:00pm – 4:30am • Demonstrate ability to give direction to others • Ability to provide instructions regarding policies and procedures
Desired Characteristics: • Associates degree in a scientific discipline or equivalent experience • Cell Culture experience • Protein Purification experience • Prior management experience • Prior experience working in a cGMP biopharmaceutical manufacturing environment • Action oriented: Able to build and develop a cohesive team unit
Locations: United States; Massachusetts; Marlborough
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