Biomanufacturing Associate II, Cell Production

United Therapeutics Corporation

2d

About The Position

As part of a start-up, new GMP manufacturing facility focused on tissue engineering and biomanufacturing, as the Biomanufacturing Associate II, Cell Production you will support activities related to the generation and maintenance of all master and working cell banks to meet departmental and company objectives. This role provides valuable hands-on experience in establishing a new GMP manufacturing operation, including the technical transfer of processes from R&D to production readiness. Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA, and United Therapeutics (Unither) policies and regulations Work as an integral member of the team to support department objectives Serve as SME for routine daily operations, working independently with limited supervision Routinely perform primary lung cell culture in both 2D and 3D formats to support the generation and maintenance of all master and working cell banks in accordance with established SOPs Routinely perform media formulation in accordance with established SOPs Monitor bioreactor systems parameters (e.g., pressure, flow, timing) and biological indicators (e.g., metabolism, nutrient consumption) Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP) Perform in-process and end-of-process sampling and testing Conduct routine analyses of in-process measurements and cell culture data Draft process deviation reports as required Perform troubleshooting of equipment issues and process deviations of moderate scope, applying discretion within established operational boundaries and procedures as required Present data and process updates in internal team meetings as needed Draft or update area SOPs and MBRs as assigned Identify, develop and implement process improvements

Requirements

• Bachelor’s Degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
• 2+ years of cGMP biomanufacturing, cell culture or tissue engineering experience
• Direct experience with primary cell culture and expansion
• Proven, hands-on experience with bioreactor systems used in tissue engineering
• Demonstrated expertise in aseptic technique
• Ability to troubleshoot issues of moderate scope
• Demonstrated ability to work effectively both independently and as part of a team in a collaborative environment
• Proficiency with Microsoft Office applications (or equivalent software) and strong general computer skills
• Strong attention to detail and adherence to Good Documentation Practices (GDP)
• Excellent verbal and written communication skills
• Ability to work flexible schedules, including shifts, to support 24/7 operations as needed
• Proven proficiency in cell culture, and aseptic technique

Responsibilities

• Operate bioprocess equipment and perform production processes in strict compliance with cGMP, OSHA, and United Therapeutics (Unither) policies and regulations
• Work as an integral member of the team to support department objectives
• Serve as SME for routine daily operations, working independently with limited supervision
• Routinely perform primary lung cell culture in both 2D and 3D formats to support the generation and maintenance of all master and working cell banks in accordance with established SOPs
• Routinely perform media formulation in accordance with established SOPs
• Monitor bioreactor systems parameters (e.g., pressure, flow, timing) and biological indicators (e.g., metabolism, nutrient consumption)
• Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
• Perform in-process and end-of-process sampling and testing
• Conduct routine analyses of in-process measurements and cell culture data
• Draft process deviation reports as required
• Perform troubleshooting of equipment issues and process deviations of moderate scope, applying discretion within established operational boundaries and procedures as required
• Present data and process updates in internal team meetings as needed
• Draft or update area SOPs and MBRs as assigned
• Identify, develop and implement process improvements

Benefits

• Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level