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Manufacturing Associate II

Employer
Aspen Neuroscience
Location
San Diego, California
Start date
Sep 13, 2022

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Job Details

Our rapidly growing team is seeking a Manufacturing Associate II  to support both quality control and research and development efforts. Grow your career in cell therapy by working on a highly collaborative team committed to excellence. This role involves activities associated with cell-related functions including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells.  We are looking for a detail-oriented person who can ensure the approved procedures and protocols are being followed, review and retaining accurate daily logs and records. If you are looking for a mission focused role, this is it. Join us as we work toward 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, onsite gym, and other wellness perks.

Company

Headquartered in San Diego, Aspen Neuroscience, Inc. is a development stage, private biotechnology company focused on personalized cell therapies. We are developing autologous (the patient’s own) induced-pluripotent stem cells (iPSCs) to address diseases with high unmet medical need, beginning with autologous neuron replacement for both sporadic and genetic forms of Parkinson’s disease (PD).

As a leading iPSC platform company, we combine stem cell biology with the latest artificial intelligence and genomic approaches to investigate patient-specific, restorative treatments. We have developed a best-in-class platform to create and characterize pluripotent-derived cell medicines, including in-house bioinformatics, manufacturing and QC.

Located in scenic Torrey Pines, Aspen features a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and collaboration. The leadership team is committed to attracting and retaining the highest caliber talent to develop meaningful therapies for patients in need.

aspen

 

Company info
Website
Phone
(858) 263-1222
Location
10835 Road to the Cure, Ste. 100
San Diego
California
92121
United States

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