Research Associate - Bioanalytical Sciences Operations

Software Guidance & Assistance, Inc., (SGA), is searching for a Research Associate - BioAnalytical Sciences Operationsfor a CONTRACT assignment with one of our premier Pharmaceutical Services clients in South San Francisco, CA .
Responsibilities :

• BioAnalytical Sciences Operations translates and applies strategy and innovation for bioanalysis and immunogenicity into clinical and non-clinical studies through global collaboration and robust CRO portfolio management.
• Our team brings technical and operational expertise along with passion and drive to make a difference for patients.
• Support the development portfolio by providing technical oversight of clinical and non-clinical bioanalytical methods including validation and lifecycle management of Ligand Binding Assays supporting pharmacokinetic, toxicokinetic, pharmacodynamic, and biomarker analyses outsourced to Contract Research Organizations (CRO).
• Review bioanalytical clinical and non-clinical method performance data generated at the CROs.
• Serve as the front-line technical contact with CROs for routine outsourcing activities in support of method qualifications and validations (Ligand Binding Assays and new technologies) and any technical questions that arise around assay performance or lifecycle management during the course of clinical, non-clinical study assay performance.
• Provide technical oversight of outsourced methods (Ligand Binding and new technologies), ensuring qualified/validated state for optimal assay quality:
• Technical review of assay data from development, feasibility, qualification/validation, assay performance from clinical/non-clinical sample analysis.
• Technical review plans (qualification/validation/sample analysis), reports (qualification/validation/sample analysis)
• Technical support during assay troubleshooting and lifecycle management
• Proprietary Critical Reagents (Reference standards, MAbs, ligands): forecasting, requesting new material, shipping, re-test date extension.
• Supplemental validations to support additional matrices, disease states, co-medications, critical reagent incorporation, Coordinate assay transfers to multiple CROs and subsequent Technical support of cross validation experiments between CROs.
• Generate internal technical reports: validation history, cross validation, or memorandum
• Share with internal key stakeholders assay data (transfer, feasibility, qualification, validation, troubleshooting, assay performance) and documents (methods, plans, reports, memorandum).
• May Lead technical teleconferences with CROs and attend internal bioanalytical working group meetings.
• This individual will work in a fast-paced and highly collaborative team based environment.
• S/he will be asked to present at bioanalytical working groups or all staff meetings and to prepare poster presentations.
• S/he may train others on group responsibilities and systems.
• S/he may also be responsible for implementation or maintenance of support systems and may lead department teams charged with improving business processes.

Required Skills:

• Bachelor's or Master's degree in Bioanalytical Sciences, Analytical Chemistry, Biochemistry or equivalent experience
• 3-8 years in industry and/or testing laboratory (Clinical, non-clinical, or CRO).
• Familiarity with bioanalytical method GxP compliance is required.
• Technical background in developing, validating, implementing, maintaining, and troubleshooting quantitative assays as well as have demonstrated problem solving abilities of bioanalytical methods in: LC-MS

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 https://sgainc.com/ .
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 EEO page to request an accommodation or assistance regarding our policy.