Manufacturing/Cell Processing Associate
Location
Pasadena, CA | United States
Job description
Responsibilities:
- You will report in to the Manager, Cell Manufacturing Process Development and work as part of a team to build Process Development Activities
- Adhere to laboratory quality systems, batch records, SOPs and cGMP regulations. Complete documentation associated with development activities and sample analysis and recording in Electronic lab note book.
- Contribute to generation of GMP documentation including batch records, SOP's, technical reports, and other documents.
- Draft, revising, and editing Standard Operating Procedures (SOPs) and Batch Records for the manufacturing process, facility and test assays.
- You will assist with Equipment evaluation and commissioning.
- Assist with routine maintenance of scientific instrumentation, and equipment.
- Maintain current training status for all applicable activities.
- Provide feedback to Lead Scientist and Manager
- Present experimental data at departmental or project meetings
- Assist with Technical Transfer of methods to the Cell Manufacturing department
- Perform analytical assays (ddPCR, CFU assay, Flow cytometry) to assist with Process development
- You will ensure high safety standards are adhered to as governed by local, state and federal regulations, laws and policies and CSL policies and directives
- Develop training material, update curricula and support ongoing training of manufacturing staff.
- Perform other duties as assigned
Qualifications:
- BS/MA in life sciences (Cellular Biology, Immunology, or Biomedical)
- Familiarity with GMP Manufacturing processes and working within a controlled environment
- 2+ years experience in cell /gene therapy processing
- Experience with analytical methods to characterize in process and final cell product samples (gene marking, CFU assay, flow cytometry)
- At least three years laboratory experience in biomedical research or a clinical laboratory with an emphasis on GMP practices, validation and execution of Laboratory SOPs and QC/QA practices. Experience in cellular biology, Immunology, Hematology and/or Hematopoietic Stem and Progenitor Cell Biology (HSPC).
- Experience in cell enrichment, culture and cryopreservation of human HSPCs.
The expected base salary range for this position at hiring is $70,000 - $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies, and other relevant factors.
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .
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