The Biomanufacturing Associate I or II (Operator) is a position responsible for execution and facilitation of cell production in a Clean Environment Area (Cleanroom). Operator will be responsible for routine tasks that are to be completed in a manner that satisfies clinical product quality standards and internal Standard Operating Procedures (SOPs) and policies.
Key responsibilities are as follows:
- Perform or verify aseptic cell biomanufacturing processes following defined batch production records in a cleanroom environment.
- Document operations on batch production records and related documentation using Good Documentation Practices (GDP).
- Enter, organize and review key process data for department tracking and trending of process performance.
- Assist in writing Standard Operating Procedures, Batch Production Records, forms, reports, deviations, root cause analysis, and corrective actions preventative actions (CAPAs).
- Order, receive and inventory process materials. Stock, clean, and stage materials in the cleanroom suites.
- Perform or coordinate maintenance of cell culture equipment per defined equipment SOPs and maintenance schedules.
- Perform routine and viable dynamic environmental monitoring (EM) in the cleanroom, ship plates, and prepare routine EM tracking and trending reports as needed.
- Perform routine analysis of cellular material and drug product including culture confluency, cell counting, and visual inspection
- Perform routine cleaning of processing equipment, cleanroom suites and support spaces.
- Assist in process optimization projects assigned by department management.
Job Requirements and Qualifications
- Degree in Biochemistry, Bioengineering, Microbiology, Molecular Biology, or a related scientific field.
- >1 year of experience in a GMP-regulated manufacturing environment.
- Understanding of GMP principles, documentation practices, and regulatory compliance.
- >1 year of experience culturing induced pluripotent stem cells (iPSCs preferred).
- Ability to perform aseptic cell culture responsibilities in a biosafety cabinet (BSC) wearing Level III gowning for extended periods of time.
- Ability to work cooperatively with all manufacturing operators as an operator/ verifier team.
- Ability to work scheduled shifts including weekends and holidays as required.
- Share responsibility to respond to off-shift alarms for equipment monitoring system.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as level of experience, education, skills, and other job-related factors.
BrainXell Therapeutics Global is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.
Pay: $60,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
