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R0023633 Sr. Associate Scientist, Biologics Analytical Operations, Cell-based Assays

Sr. Associate Scientist, Biologics Analytical Operations, Cell-based Assays – Oceanside, CA
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.
Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
We are seeking a Sr. Associate Scientist, Biologics Analytical Operations to join our rapidly growing Oceanside team.
Specific Responsibilities and skills for position
  • A good understanding of Bioassay method development (ELISA, Receptor Binding, Flow Cytometry, and Cell-based) for early and late stage biotherapeutics is required. The successful candidate will be expected to demonstrate hands-on experimental responsibilities in the laboratory, independently champion technology development projects, be involved in new assay evaluation and optimization, and define GMP potency platforms.
  • The candidate will contribute to developing and validating potency assays, confirming the potency of final drug substance and drug product, and supporting lot release and stability QC testing. The candidate will also participate in structure activity relationship work as part of a team to characterize the molecule, degradation pathways and define critical quality attributes in a phase appropriate context. The candidate will also participate in process development and compatibility studies.
  • Works with Gilead internal researchers in the identification and selection of robust potency assays and optimization efforts for GMP applications. Identifies and deploys orthogonal characterization methods to aid in identifying critical quality attributes. Responsible for production and maintenance of all critical custom reagents and cell lines used in development and QC potency assays.
  • The applicant should be an effective communicator of ideas, project goals and results to team members across cross-functional roles/departments. Ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment. This is a highly collaborative environment where willingness and ability to communicate and work effectively with individuals across various project teams is essential.
  • Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment. The applicant is also expected to exercise considerable latitude in determining objectives and approaches to assignments, and should be an effective communicator of ideas, project goals, and results to team members across cross-functional roles/departments. 
Essential Duties and Job Functions
  • Under general supervision, develop and validate potency assays to support biological drug development.
  • Demonstrate hands-on experimental responsibilities in the laboratory including aseptic technique, routine cell culturing and performance of plate-based assays.
  • Operates scientific equipment, selects appropriate methods and techniques to perform experiments, and prepare related reports. Plans and organizes details of experiments with guidance.
  • Demonstrate good verbal communication skills and interpersonal skills. Be able to work in a fast-paced and highly collaborative working environment.
  • Knowledge of GMP, GLP or GxP is highly preferred.
Job Requirements:
  • 11+ years of experience with BA or BS degree in Chemistry or Biology.
  • 9+ years of experience with MS degree in Chemistry or Biology.
  • PhD with no post-doctoral assignment.
Preferred Experience:
  • Good communication skills (both verbal and technical) and interpersonal skills are required. Must be able to work in highly flexible and effective teams.
  • Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Demonstrates high attention to detail, ability to recognize anomalous and inconsistent results and interpret experimental outcomes. Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy. Experience with GMP validation and testing is preferred.