Sr. BMA Downstream
Position Summary
The Sr. Biomanufacturing Associate plays a key role within the gene therapy manufacturing function by applying biological, bioprocess, manufacturing, mechanical, application, system, and technology principles, processes, procedures, inputs, and outputs for designated production processes and handovers within a regulated environment to ensure the timely production and release of quality products, based on client specifications.
Key Responsibilities And Duties
Apply and adhere to SOPs, cGMP, GLP, Quality, and Safety requirements.
Independently execute floor-level tasks, in line with SOPs in one or more areas: Downstream Activities, Fill-Finish Activities, Assist in coordinating and executing floor activities, in alignment with the batch record.
Apply advanced GDP when preparing, editing, reviewing, and implementing Quality documents.
Perform daily BPR reviews to ensure completion.
Participate in/co-lead GMP audits and investigations.
Ensure high data integrity when accurately documenting, analyzing, and reviewing work.
Prepare, clean, maintain, inspect, and operate equipment; assist with calibrations.
Troubleshoot routine to moderately complex issues, using root cause analysis.
Co-lead health and safety prevention initiatives to reduce risk.
Comply with safety regulations and site-based guidelines by applying: Cleanroom and aseptic behaviors and procedures, PPE and gowning requirements, proper preparation, disinfection, sterilization, and sanitation methods/processes for equipment, etc.
Understand biosafety levels and apply specific controls, Universal precautions/OSHA guidelines.
Absorb, train, assist, and mentor others to avoid accidents or other unsafe situations.
Provide recommendations and implement Continuous Improvement/LEAN solutions to create efficiencies.
Ensure 100% on time completion of own/others training plans; ensure they are maintained and up to date.
Be punctual and flexible with work schedule, tasks, etc. to support business demands.
Perform other responsibilities as required.
Qualifications
HS Diploma/equivalent and 6 years of related experience, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience.
Prior cell/gene therapy experience in a highly technical role, covering a wide range of tasks, within a cGMP/biotech manufacturing environment or related industry/role.
Informal coaching or project management experience is desirable.
Additional Requisition Requirements
HS Diploma/equivalent and 6 years of related experience in Downstream cGMP operations, A.S. with 5 years, or a B.S. in biology/life sciences, bioengineering, or related discipline with 3 years of related experience.
Prior cell/gene therapy experience in a highly technical role, covering a wide range of tasks, within a cGMP/biotech manufacturing environment or related industry/role.
Informal coaching or project management experience is desirable.
Pay
Pay ranges between $22-31.50/hr based on experience.