With the commitment and drive you bring to the Pharmaceutical Development & Manufacturing (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.
Positioned within the Analytical Operations (AO) department of Gilead Pharmaceutical Development & Manufacturing (PDM), accountable for the leadership activities and for directing all facets of Stability, including but not limited to: procedures, stability study design and execution, analytical results interpretation, shelf-life, regulatory filings (Stability section), and interaction with regulatory bodies.
Specific Responsibilities & Skills for the Position:
• Establish stability standards, business processes, and tools for management of Gilead stability programs and drive continuous improvement.
• Oversee day-to-day operation of Stability (Stability protocol design and execution, stability chamber maintenance, interactions with partners and other collaborators).
• Provide both technical and operational chemistry expertise (Pharmaceutical Chemistry/Stability) for training, product investigations, deviations, CAPA, quality and operational improvements, etc., to ensure continued compliance with regulations.
• Provide key leadership, direction, and technical expertise to the Stability group and support teams to ensure product quality guidelines are consistently met.
• Coordinate timely and right the first time delivery of stability results required by CMC Regulatory groups, and for support of Manufacturing and laboratory investigations.
• Perform critical and scientifically sound data analysis and interpretation, including statistical analysis for comparability studies, shelf-life, degradation rates, trending, specification setting, and impact.
• Champion specification setting initiatives in support of product development, manufacturing and regulatory filings.
• Advise Manufacturing, QA, RA, Facilities and Material Management on stability strategy, regulatory requirements, and stability issues associated with products.
• Lead the stability topics in inspections conducted by external regulators and business partners to defend product shelf life.
• Serve as a role model for behavior that is consistent with the mission, vision and values of the PDM/AO organization with respect to quality, safety, performance, compliance and collaboration.
• 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.
• PhD with Post Doc in Chemistry with industry experience.
• BS or MS degree with extensive industry experience.
• Strongly prefer minimum MA/MS in Analytical Chemistry, Pharmaceutical Chemistry, or related field with 10+ years of supervisory experience in an Analytical Testing Laboratory or QC Stability (Ph.D. preferred).
• Must have expert knowledge in statistical analysis and trending of stability data, and be well-versed in current stability strategies and requirements within the pharmaceutical industry.
• Excellent communications skills are required to ensure effective cross-functional interactions and timely issue escalation to senior management.
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.