Associate Scientist-Cell Therapy

Software Guidance & Assistance, Inc., (SGA), is searching for an Associate Scientist- Cell Therapy for a contract assignment with one of our premier Pharmaceutical Services clients in San Diego, CA.

Responsibilities :
We are seeking an experienced and motivated Associate Scientist to join the Analytical Development team at the firm,. This position works with the PTCC team to develop and/or improve cell-based assays for cell product characterization and release. The Analytical Development Associate Scientist participates in laboratory activities to support process development, evaluate and develop new assay methods, and perform product characterization for CAR-T cell products. Also involved in assay optimization and standardization and assay transfer to internal or external QC labs. Under the reasonable supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.

• These may include but are not limited to:
  • Develops analytical test method procedures in accordance with relevant guidelines from ICH, USP, EP for cell therapy product GMP release testing and characterization.
  • Supports analytical routine testing, qualification, and validation.
  • Evaluates reagents and supplies to meet QC standards
  • Co-authors test methods (SOPs), technical reports, and analytical sampling plans
  • Documents laboratory procedures and experiments with great attention to detail in laboratory notebooks
  • Performs assays for process assessment and product characterization
  • Participates in assay transfers to QC and provides lifecycle support
  • Summarize and present scientific data to project teams.
  • Evaluates alternative technologies to create robust and reproducible analytical methods
  • Sets up, monitors, samples, and analyzes cell culture processes
  • Works with R&D teams to gain deeper understanding of the analytical methods for characterization of product critical quality attributes

Required Skills:

• BS or MS degree in a relevant scientific discipline with five plus years of relevant experience in a biotech environment (an equivalent combination of education and experience may be considered)
• Experience in human T cell biology with demonstrated proficiency in a broad range of cellular immunology techniques, including cell-based assays, immunoassays, and flow cytometry.
• Experiences with aseptic cell culture (human primary cells and cell lines) and bio-assay development and/or testing
• Ability to follow laboratory procedures with attention to detail, and successfully execute experiments at the bench
• Demonstrated ability to maintain detailed lab execution records and perform data analysis
• Excellent communication skills, data presentation and interpersonal skills
• Basic computer skills in Excel, PowerPoint, and word processing
• Attention to detail, initiative, and strong organizational skills
• Comfortable in a fast-paced small company environment with reasonable direction and able to adjust workload based upon changing priorities.

Preferred Skills:

• Two plus years of relevant cell therapy industry experience
• Foundation in experimental documentation, basic statistical analysis, and data presentation
• Exposure in vitro T cell functional assays (potency, cytotoxicity, ELISA, proliferation, Luminex)
• Basic skills in molecular techniques including qPCR or ddPCR and electrophoresis.
• Experience with drafting SOP and forms
• Develops assays for cell product release and characterization by designing and executing studies via design of experiment (DoE)

SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy.
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