General Electric BioManufacturing Supervisor: Sunday – Wednesday 7 AM to 5:30 PM in Marlborough, Massachusetts
Role Summary:As Biomanufacturing Supervisor, perform / direct MFG operations via standard operating procedures and batch instructions. Direct daily scheduled work in assigned areas. Train on cGMP manufacturing operations: Operation and monitoring of cell culture/purification equipment; Media/solution preparation; Write/review/revise cGMP documentation. Execute daily/weekly/monthly forecasted Solution Preparation production priorities to meet output quotas and group performance goals.
Essential Responsibilities:• Be the shift lead, providing instruction to the team, including performance assessments and disciplining.
• Demonstrate effective written and verbal communication skills and provides instruction to others when required.
• Ability to work within ISO 5/6/7/8 clean room environments.
• 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).
• 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
• Work with cross-functional teams on the implementation of process improvement initiatives to increase quality and productivity levels.
• 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:• B.S./B.A. in Biotechnology, or related field, with minimum of 2 years experience in biologics manufacturing under cGMP; OR Associates Degree/ Biotechnology Certificate/Diploma with a minimum of 4 years experience in biologics manufacturing under cGMP.
• Ability to communicate expectations and hold team accountable to all production, safety and quality requirements.
• Demonstrate ability to give direction to others.
• Ability to provide instructions regarding policies and procedures.
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Desired Characteristics:• 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.
• Experience with Trackwise, Electronic Document Management Systems or other electronic tracking software.
• Experience with single-use biomanufacturing systems.
• Action oriented: able to build and develop a cohesive team unit.
About Us:GE Healthcare Life Sciences www.corporate.gehealthcare.com There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than 11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future. We are accelerating biology to cell therapy in ways no other company can. Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.
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, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.
Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Connecticut, Massachusetts, New Hampshire, Rhode Island;Marlborough, Westborough, Boston, Hartford, Nashua, Providence;
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