- Perform all tasks associated with the manufacture of clinical product following batch records and SOPs
- Work as part of a small team to execute GMP runs in close collaboration with Process Development, Facilities and Quality departments
- Assist in the development of standard operating procedures (SOPs), master batch records (MBRs), deviations and change controls
- Ensure right-the-first time performance of all process steps specific to the phase or state of operation, as well as drive the safety-first culture at ImmPACT-Bio
- Assist with authoring new or revise existing SOPs, MBRs, and other process documents
- Successfully troubleshoot processing and equipment issues
- Daily, real-time review of in-process cGMP documentation for completeness and accuracy
- Assist with change control and investigations required to manage deviations
- Train personnel on applicable procedures and equipment
- Other duties as assigned
- B.S./M.S. plus a minimum of 0-4+ years of relevant experience in a clinical manufacturing operation, manufacturing sciences, technology, or manufacturing technical support role. Cell therapy-based therapeutics such as CAR-T, or other cell-based products is a plus
- Strict adherence to SOPs and cGMP regulations, the ability to accurately complete documentation associated with clinical manufacturing
- Excellent aseptic/sterile techniques and prior experience with cell culture, cell culture equipment including Sepax and CliniMAX
- Self-motivated, detail-oriented, good interpersonal and writing skills
- Experience with handling and propagation of human primary cells, including T cells
- Excellent skill in Microsoft Word, Excel and data analysis
- Able to work Tuesday - Saturday shift
- Ability to lift over 30 lbs
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell culture products
- Ability to think critically, and demonstrate troubleshooting and problem-solving skills
- Excellent interpersonal, verbal and written communication skills
- Ability to function efficiently and independently in a changing environment
- Self-motivated and willing to accept temporary responsibilities outside of initial job description
- West Hills, California
- Up to 15% travel
- Willingness to travel domestically and internationally for business meetings and scientific conferences
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Cell Therapy Specialist I-IV - West Hills, United States - ImmPACT Bio
Description
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases.
The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment.
The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.
D., both from UCLA.
ImmPACT Bio is looking for an exceptional individual to join our growing team as a Cell Therapy Specialist. This position will report directly to the Supervisor, Manufacturing and be responsible for the manufacturing of clinical product.
Primary Responsibilities:
Preferred Qualifications:
Location:
Travel Requirements:
We believe in offering and maintaining competitive compensation and benefits programs for our employees to attract and retain a talented, highly engaged workforce.
Our compensation programs are focused on fair and equitable pay practices including market based and data supported base pay, an annual performance-based bonus plan, and equity grants (ISO) for new employees.
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.Salary Range
$25-$44.50 USD
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs.
ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
All information will be kept confidential according to EEO guidelines.