Manufacturing Associate

Location
San Diego, California
Posted
Apr 20, 2022
Ref
58540
Hotbed
Biotech Beach
Required Education
Associate Degree
Position Type
Full time

SUMMARY:  

Our rapidly growing team is seeking a Manufacturing Associate to support both quality control and research and development efforts. Grow your career in cell therapy by working on activities associated with cell-related functions; including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells. This person is responsible for ensuring the approved procedures and protocols are being followed per 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 for Aspen’s first-in-human clinical trial for the treatment of Parkinson’s Disease.


DUTIES AND RESPONSIBILITIES:

  • Manufacturing of clinical cell therapy product under GMP in a controlled cleanroom environment. Some of these duties may include cell expansion, cell feeding, harvesting, counting and freezing, product seeding, labeling, intermediate formulations, and operation of lab equipment.
  • Maintains equipment and inventory for manufacturing and process development operations. 
  • Begins process of training employees in easier job procedures for tissue culture and media preparation, equipment operation, safety, and other phases of their job, as necessary.
  • Testing and release of raw materials/new reagent lots and identify and comparatively test alternative tissue culture material/reagent sources, working with QC. 
  • Assist management with additional duties as necessary – Review documents, assist with ERP functions (inventory and equipment maintenance, supply orders), trending and data management, attend meetings as SME.
  • Supports a Process Engineer in manufacturing cell lots for process and assay development. 
  • Works within a cross-functional team of scientists, engineers, bioinformatic specialists and research associates to ensure success of Aspen Neuroscience’s clinical programs. 
  • Reporting of conflicts and/or process issues to supervisor.
  • Writing standard operating procedures, batch records, and quality documents.
  • Assist in providing positive and constructive individual feedback and building teamwork.
  • 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
  • 3-4 years of experience working in pharmaceutical/biotechnology industry with first-hand understanding of mammalian cell culture, composing and supplementing media, cleanroom (ISO 7 and 5), (fibroblast, primary tissue culture, and iPSC cells a plus).
  • Experience with cell culture and media operations.
  • 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, gym membership, and other wellness perks.