The Manufacturing Associate I supports 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. Responsible for performing routine equipment maintenance and raw materials receiving and testing. This is a fully onsite position located in Torrey Pines.
DUTIES AND RESPONSIBILITIES:
- Manufacture clinical cell therapy products under Good Manufacturing Practices (GMP)in a controlled cleanroom environment, including but are not limited to 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.
- Assist manufacturing technician(s) with inventory and equipment management responsibilities including moving orders, wiping and staging material into cleanroom/ Kan Ban and training areas, inventory tracking, and cycle counts.
- Collaborate within a cross-functional team of scientists, engineers, bioinformatic specialists and research associates to ensure success of Aspen Neuroscience’s clinical programs.
- Report conflicts and/or process issues to Lead/ Supervisor/ Manager.
- Assist with writing or reviewing standard operating procedures, batch records, and quality documents.
- Assist with writing and performing investigations for deviation, CAPAs (corrective and preventative actions), NCMR (Non-conforming material report) and OOS (Out of Specification).
- Order documents and labels from the Quality department.
- 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 engineering
- Some experience working in pharmaceutical/biotechnology industry with understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and 5), (fibroblast, primary tissue culture, and iPSC cells a plus), is preferred.
- Good understanding of CMC development and manufacturing is preferred. • Ability to provide positive and constructive individual feedback and build teamwork.
- Excellent oral and written communication, interpersonal, analytical and computer skills.
- Solid knowledge of Microsoft Office programs and project management tools.
- Familiar with documenting each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
- Ability to work in a cleanroom environment while gowned for an extended period.
- Ability to work a flexible schedule required. 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), Batch Records, 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 $21/hr. to $32/hr. hourly. The final salary 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.