The Manufacturing Associate II will support manufacturing production and research and development efforts. This includes activities such as producing cells and intermediate products related to fibroblasts, induced pluripotent stem cells (iPSC), and derived dopaminergic progenitor cells. This role is responsible for ensuring the approved procedures and protocols are followed per standard operating procedures (SOP). Reviewing and retaining accurate daily logs and records as well as instructing subordinates with training needs. Responsible for performing routine equipment maintenance and raw materials receiving and testing. This position is fully onsite and the shift for this role is Sunday-Thursday.
DUTIES AND RESPONSIBILITIES:
- Manufacture clinical cell therapy products under Good Manufacturing Practices (GMP) in a controlled cleanroom environment, including cell expansion, cell feeding, passaging, harvesting, counting, freezing, product seeding, and labeling, intermediate formulations, and operation of lab equipment.
- Participate in annual/ bi-annual qualifications including training protocols, gowning, operator aseptic qualifications, equipment and facility qualifications and aseptic process simulations.
- Begin the process of training employees in lower-level job procedures for tissue culture, media preparation, equipment operation, safety, scheduling, and other phases of their job, as necessary.
- Work with trainers from various departments such as Quality Control, Quality Assurance, Material Management, and Facilities for coordination of production, equipment, and material activities.
- Assist with ERP (enterprise resource planning) functions, including inventory and equipment maintenance (Kan-Ban), supply and move orders, performing regular cycle counts. • Assist with wiping and staging material into training, controlled, and cleanroom areas.
- Perform review of documents, trending, and data management.
- Attend cross functional meetings as a subject matter expert (SME).
- Support a Process Engineer in manufacturing cell lots for process and assay development.
- Collaborate within a cross-functional team of scientists, engineers, bioinformatic specialists and research associates.
- Report conflicts and/or process issues to Lead/ Supervisor/ Manager.
- Write, review, and revise standard operating procedures, batch records, and quality documents.
- Write and perform investigations for deviation, CAPAs (corrective and preventative actions), NCMR (Non-conforming material report) and OOS (Out of Specification).
- Other duties and responsibilities as assigned.
EDUCATION AND EXPERIENCE:
- Associate degree or higher and/or a Biotech Program certificate from an accredited college, or equivalent industry experience in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, biotechnology, molecular biology, chemical or bioengineering.
- Minimum 2 years of experience working in pharmaceutical/biotechnology industry.
- First-hand understanding/ experience with cell culture (preferably adherent mammalian culture) and composing/ supplementing media required. • Working experience in cleanroom (ISO 7 and 5), fibroblast, primary tissue culture, and iPSC cells preferred.
- Some trainer experience preferred.
- Good understanding of CMC development and manufacturing is desired.
- Excellent oral and written communication, interpersonal, analytical and computer skills.
- Solid knowledge of Microsoft Office programs and other project management tools
- Familiar with documenting each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
- Knowledge of ISO, Quality Systems, and FDA regulations.
- Ability to work a flexible schedule. Overtime, holiday, and weekend work may be needed to meet the needs of the current manufacturing project.
- Ability to write reports, business correspondence, Standard Operating Procedures (SOPs), BRs, and Quality/Compliance related documents.