Biomanufacturing Associate I - Production Support

United Therapeutics•Rtp, NC

3d•Onsite

About The Position

As part of a start-up, new GMP manufacturing facility focused on tissue engineering and biomanufacturing, the Biomanufacturing Associate I, Production Support, will support activities related to manufacturing operations and material handling to support multiple manufacturing teams to meet departmental and company objectives. This role provides valuable hands-on experience in GMP manufacturing operations.

Requirements

Bachelor’s degree in biology, biotechnology, biomedical engineering, or a related scientific discipline
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 and on call as needed
Proven proficiency in aseptic technique

Nice To Haves

1+ years of cGMP biomanufacturing, R&D, or laboratory operations experience

Responsibilities

Operate bioprocess equipment and perform production support 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
Responsible for daily monitoring and restocking of supplies and materials; ensure proper inventory rotation (first in first out) and monitor supply expiration dates
Monitor JIT warehouse inventory, submit materials requests to transfer materials from main warehouse to JIT warehouse
Routinely prepare team supplies (e.g. single use assemblies, media, buffer) in accordance with established SOPs
Perform autoclave and parts wash runs.
Prepare surgical pans, instruments and other supplies for sterilization
Assist scaffold production with dissection process.
Assist recellularization, cell production with other routine tasks as needed
Schedule preventative maintenance and calibration (escort vendors in and out) according to Blue Mountain Ram system, to ensure all standalone equipment is maintained according to the schedule
Accurately and promptly record data in batch records, logbooks, and system documentation in accordance with Good Documentation Practices (GDP)
Perform basic troubleshooting of equipment issues or process deviations
Draft process deviation reports as required
Perform other duties as assigned