Sr. Manufacturing Associate

Manufacturing              ·           San Diego, CA           ·           Full time

•  San Diego, California
• Category: Manufacturing
• Type: Full-time
• Min. Experience: Senior Level
  
• Salary: $29.00 – $44.00 per hour

Summary

Aspen is seeking a Manufacturing Associate III (Sr.) to join our highly collaborative team. This role serves as SME associated with cell-related functions including producing cells and intermediate products related to induced pluripotent stem cells (iPSC) derived dopaminergic progenitor cells.  The ideal candidate is a detail-oriented, quick learner who can teach and train others to ensure the approved procedures and protocols are being followed. If you are looking for a mission focused role, this is it. Join us as we work toward developing a treatment for patients with Parkinson’s Disease. This position is fully onsite and the shift for this role is Sunday-Thursday. 

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.
• Assist management and lead associate with scheduling and distributing work to associate employees, to ensure the uninterrupted process of product in and out of the area.
• Assist with making decisions related to daily activities, break schedules, and prioritizing of work on the production floor when lead associate or management are unavailable.
• Instruct and train employees in job procedures, equipment operation, safety and other phases of their job, as necessary.
• Maintain equipment and inventory for manufacturing and process development operations.
• Begin 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.
• Review and retain accurate daily logs and records as well as assisting subordinates with training needs.
• Responsible for troubleshooting manufacturing product challenges to ensure optimal decisions are made while collaborating with external groups.
• 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.
• Anticipate and address production issues and collaborate with other departments on resolutions and improvements.
• Assist in writing standard operating procedures, batch records, and quality documents.
• May participate in the interviewing process of new manufacturing candidates when necessary.
• Assist in providing positive and constructive individual feedback and building teamwork – sets example for other employees.
• Other duties and responsibilities as assigned.

Education And Experience: 

• Bachelor’s, or equivalent industry experience in a relevant technical discipline such as biology, chemistry, pharmaceutical sciences, biochemistry, molecular biology, chemical engineering or equivalent
• Minimum 5 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). Equivalent combination of knowledge and experience will be considered.
• Trainer experience.
• Experience with cell culture operations and familiarity with execution and troubleshooting of moderate to complex scheduling activities is a must.

Job Specifications: 

• Ability to work within a cross-functional team of scientists, engineers, bioinformatic specialists and research associates to ensure success of Aspen Neuroscience’s clinical programs.
• Knowledge of ISO, Quality Systems, and FDA regulations.
• Must be able to follow established company rules, regulations, and safety precautions to maintain quality standards.
• 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 task documentation, cleaning procedures, aseptic processing techniques, and Good Manufacturing Practices (GMP) and clean room safety practices and procedures.
• Ability to work a flexible schedule. Overtime, holiday, and weekend work may be needed to meet the needs of the current manufacturing project.
• Strong 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 $29-$44 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.

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