Scientist II Bioanalytical Assay Manager

Software Guidance & Assistance, Inc., (SGA), is searching for a Scientist II Bioanalytical Assay Manager for a contract assignment with one of our premier Pharmaceutical services clients in South San Francisco, CA.

Responsibilities :
A Bioanalytical Assay Manager is a highly motivated and collaborative individual who participates in the evaluation of validation/qualification reports as well as oversight of assay transfer, feasibility, lifecycle management of immunoassays and mass spectrometry assays to measure biomarkers at Contract Research Organization (CRO) in support of pre-clinical and clinical studies. This individual will work across the organization to help harmonize CRO, platform and assay selection and use. This job does not involve hands-on work in the laboratory.

• Review of validation/qualification documents and bioanalytical reports.
• Assist with the transfer of reagents and method documentation, assay transfer and sample analysis plans, from feasibility to validation/qualification.
• Assist with the experimental design and protocol language, evaluate project team data to ensure integrity from a technical perspective and troubleshoot technical problems at the CROs, review CRO technical reports, and may present at BAS working groups.
• Support and provide oversight of assay life cycle management at CROs, which will require critical reagent forecasting, requesting of new reagent preparation [within and external to Bioanalytical Sciences Department (BAS)] and shipment to the CRO, review of reagent incorporation/troubleshooting, reagent re-test date extension.
• May be required to attend and participate in technical teleconference with CROs and internal BAS bioanalytical and safety biomarker working groups.
• Register and maintain assays in internal database systems and webpages.

Required Skills:

• B.S. in Biological Sciences or equivalent with a 3 to 5 years' hands-on laboratory experience in developing/qualifying quantitative ligand binding methods.
• Familiarity with biochemistry, cellular and molecular biology methods, new analytical technologies, Project management software would be an important advantage. Practical knowledge and understanding of computerized data handling are essential.
• Excellent communication (email, phone, teleconference), interpersonal, and organizational skills are essential.
• Must be a good team player able to work in a fast-paced and highly collaborative environment and be able to work independently as well as on a team.
• Should be able to multi-task and prioritize work well, and to consistently demonstrate initiative and creativity.

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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