Research Scientist I, Analytical Operations 8/9/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONAPPLY SPECIFIC RESPONSIBILITIES
With the commitment and drive you bring to the PDM workplace, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going 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 PDM at Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
* Manage External Event Tracking activities to ensure on-time closure.
* Support Analytical Operations Subject Matter Experts (SMEs) to ensure appropriate impact assessments and justification are completed.
* Support Clinical, Commercial, and Analytical QA by providing Analytical Data for External Event Tracking Records (EET).
* Work with AO SMEs to pull appropriate Analytical Data in support of investigations for EETs
* Work with CXOs and QA to ensure investigations are thorough and complete.
* Provide daily, weekly, monthly notification to AO and QA of EETs.
* Writing Production, Maintenance, Engineering, and Laboratory Investigations
* Write EET reports, deviation reports (DV), laboratory event (LE) summary reports, Corrective Action/Preventive Action (CAPA) summary reports, , effectiveness check (EC) records, and change management records (CM).
* Conduct investigations thoroughly to identify all impacts to patients, product quality, validated state, and regulatory compliance
* Conduct root cause analysis to identify all contributing and potentially contributing factors for which led to the deviation
* Perform risk analysis as needed to determine likelihood and severity of recurrence
* Address impact to systems, processes, product, and any regulatory requirements
* Identify and develop meaningful and effective CAPAs
* Monitor completion of EETs, DVs, LEs, CAPAs, ECs, and CMs
* Prioritize and organize EETs, DVs, LEs, CAPAs, ECs, and CMs to ensure timely completion
* Conduct interviews and properly document interviews as appropriate to laboratory investigations and deviations
* Perform all technical writing with grammatically correctness, conciseness, accuracy, and completeness with timely completion to meet appropriate deadlines
* Troubleshoot instrumentation/test methods
* Lead/coordinate cross functional projects with limited direction
* Perform metrics as appropriate for EETs, DVs, LEs, CAPAs, ECs, and CMs
* Perform monthly, quarterly and annual reports of quality records and assess trends
* Provide general training activities related to quality records management
ESSENTIAL DUTIES AND JOB FUNCTIONS
Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
Applies the principles and techniques of Analytical Chemistry to products and problems.
Works under supervision of more senior scientists or scientific directors to advance the development of state-of-the-art techniques to characterize substances, assays and tools.
Working under general supervision, plans designs, implements and analyzes laboratory experimentation to advance scientific knowledge of drug substances or techniques to identify such substances.
Advises Research Associates or members of project teams in the initiation and execution of laboratory experimentation, considering economic, regulatory and safety factors.
Presents results of work, interprets data, and draws conclusions regarding presented material and nature of work.
Maintains full working knowledge of principles and theories, applying such knowledge to the direction that supports Company interests.
Demonstrates emerging ability in developing methods, techniques and evaluation criteria for obtaining results and interpreting experimental outcomes.
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.
May make contributions to scientific literature and conferences or regulatory filings.
Excellent communication skills (both verbal and technical) and strong interpersonal skills are required.
KNOWLEDGE, EXPERIENCE AND SKILLS
PhD with Post Doc in Chemistry with limited industry experience.
BS or MS degree with extensive industry experience.
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 email@example.com for assistance.
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