Sr or Associate Principal Scientist Flow_PCR_Elispot Platforms

Benefits

• 401(k)
• 401(k) matching
• Bonus based on performance
• Dental insurance
• Health insurance
• Paid time off
• Parental leave
• Vision insurance
• Wellness resources

Crystal Bio Solutions is a CRO providing global-standard services in GLP/GCLP bioanalysis and biomarker. Our clients include multinational pharmaceutical companies and biotech companies. The Bioanalysis & Biomarkers Department specializes in Method Development, Method Validation, GLP/GCLP Bioanalysis for PK, immunogenicity and biomarkers. The team has successfully supported non-GLP, GLP (non-clinical) and GCLP (clinical) projects. The role is responsible for providing bioanalytical support for both pre-clinical and clinical projects and partnering with our clients for project success.

• Independently propose assay design and/or strategy, develop, validate, conduct, and troubleshoot bioanalytical methods, including PK, and Biomarker, for GLP/GCLP sample testing and data reporting. Present and interpret data internally and/or externally as needed.
• Serve as the Principal Investigator responsible for interaction with the client from the study design to scheduling, conducting, reporting, and transferring data. Ensure responsiveness to the client, timely delivery, and overall customer satisfaction.
• Serve as Subject Matter Expert (SME) for FLOW Cytometry
• Author and/or review key regulatory documents, validation plans and reports, laboratory data, and technical reports.
• Provide oversight of the laboratory, mentor junior staff, and collaborate to keep improving operational excellence.
• Assist in establishing and improving policies, procedures, work instructions and SOPs.
• Understand and adhere to corporate standards regarding code of conduct, Environment Health & Safety (EHS), and GLP/GCP/GDP compliance.
• Perform other related duties as assigned.

• Ph.D., M.Sc., M.A., B.A., in Biology, Immunology, Chemistry, Pharmacology, or other related scientific fields required, including a minimum of 4+ years (Ph.D.), 9+ years (Master’s) or 12+ years (Bachelor’s) of Pharma/Biotech/CRO experience.
• Hands-on experience and strong knowledge of GLP/GCLP bioanalysis.
• Experience in Flow Method Development, Validation for PK, and PD Biomarker assays.
• Knowledge and hands on experience in one or more of the following assay platforms, Cell-Based Assays, qPCR, dPCR, ELISpot, are highly desirable
• Supervisory experience in both project and talent (people) management is preferred.
• Ability to work independently and pay good attention to details.
• Ability to achieve objectives/timelines through collaborative efforts with co-workers, managers, and clients.
• Must be goal-oriented, compliance-ensured, quality-conscientious, and client-focused.
• Effective writing and communication skills.