Cell Therapy Specialist I-IV
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:
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
Preferred
Qualifications:
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
Location:
West Hills, California
Travel Requirements:
Up to 15% travel
Willingness to travel domestically and internationally for business meetings and scientific conferences
At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy. 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.Estimated Salary: $20 to $28 per hour based on qualifications.
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:
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
Preferred
Qualifications:
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
Location:
West Hills, California
Travel Requirements:
Up to 15% travel
Willingness to travel domestically and internationally for business meetings and scientific conferences
At ImmPACT Bio we embrace transparency in our total rewards pay and benefits program and philosophy. 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.Estimated Salary: $20 to $28 per hour based on qualifications.
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