Associate Scientist II - Biologics Analytical Development
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POST DATE 9/9/2016
END DATE 10/10/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
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 need and improve lives by advancing the care of patients with life-threatening diseases.
Gilead is investing in biopharmaceuticals via in-house research, clinical trials, and acquisitions of research, process development and clinical manufacturing assets. Gilead has an opportunity for an experienced candidate in our Biologics Development operations at our Oceanside facility in Southern California. We are seeking motivated, team-oriented individuals with scientific expertise in analytical development as well as pre-clinical and clinical operations related to analysis of recombinant proteins. Reporting a Research Scientist II in Analytical Development, you will have the opportunity to work in teams for early and late stage clinical development of our protein therapeutics.
Contributes to analytical method development and qualification to support protein characterization activities.
Familiarity with several of the following is highly desired: Peptide mapping by LC-MS/MS, intact mass analysis, MS/MS for protein and carbohydrate structural elucidation/quantification, bioinformatics, kinetic analyses, ultra-performance chromatography, proteolytic/chemical processing, and data analysis algorithms.
Works as part of a team member to characterize molecules, degradation pathways and define critical quality attributes in a phase-appropriate context.
Participates in process comparability studies and coordinates analysis of in- process and product related impurities as needed.
Works closely on problems of moderate complexity.
Maintains familiarity with scientific literature and applies appropriately to projects.
Attention to detail and excellence in scientific report preparation and is expected.
Works in a cross-functional environment and provides analytical support for molecule selection and bioprocess development.
Represents the company at national/international conferences as needed.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Independently plans and executes experiments that support development activities and project goals.
Applies advanced level of understanding of project goals and methods.
Selects appropriate, efficient methods and techniques in performing analysis and development.
May design new experiments to support development of drug substances and drug products or techniques to test such substances.
Recommends alternatives, researches new methods and techniques and may proactively seek out senior personnel to discuss potential solutions to problems.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Works independently and determines methods and techniques on new or difficult assignments.
Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.
Acts as a resource for other employees within the department.
Maintains high level of expertise through familiarity with scientific literature and applies appropriately to development projects.
Uses strong communication skills (both verbal and technical) and interpersonal skills to communicate objectives and results.
Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
KNOWLEDGE, EXPERIENCE AND SKILLS
9+ years of experience with BS degree in a relevant scientific discipline.
7+ years of experience with MS degree in a relevant scientific discipline.
Method development/characterization experience for protein and or carbohydrates using mass spectrometry.
Demonstrates ability to work under limited direction. Independently determines and develops approach to solution. Collaborates with supervisory personnel as needed.
Communicates scientific results efficiently.
Knowledge of ICH guidelines and CMC is a plus.
Preference for someone with great organizational, time management, and interpersonal skills.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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