Manufacturing Associate II

SUMMARY:

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.
  

JOB SPECIFICATIONS:

• 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.

EEO and Employment Eligibility:

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $23.-$36 hourly. The final compensation offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.  Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.