Senior Associate Scientist, QC

职位描述

Senior Associate Scientist, QC PDM - Biologics Analytical Operations

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.

Role and Responsibilities:

The successful candidate will possess a detailed understanding of Quality Control in support of large molecule manufacturing. The candidate must be highly motivated to contribute to the development of biologics targeting unmet medical need through the establishment and leadership of a high performing team supporting clinical and commercial programs.  This role will have responsibility for oversite of external analytical testing, internal and external method performance monitoring, product performance monitoring, existing methods and specifications, QC impacting change controls, and investigation oversight.

Essential Duties and Job Functions:

• Manages the Quality Control product quality function for defined molecules, ensuring processes provide high quality analytical support for internal and external production, product monitoring and trending, and collaboration with process and analytical development while ensuring compliance of protocols, GMP’s, and safety regulations.
• Provides oversite of the Quality Control testing execution at multiple contract sites, ensuring laboratory processes provide high quality analytical support for lot disposition and/or stability.
• Own and direct efforts in support of Quality Systems records, deviations, CAPAs, and change controls.
• Leads and represents QC requirements on multiple projects.
• Works with Regulatory & Quality Assurance to ensure that all procedures and applicable regulatory requirements are followed and properly documented.
• 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.
• Must be able to analyze process, lead improvement activities, and endeavor to participate with and create a lean culture in the laboratory.
• Will work on more complex problems where analysis of situations or data requires in-depth evaluation of various factors, strong judgment is required in resolving problems and making recommendations – typically high impact issues that have implications across functions.
• Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function.
• Demonstrated ability in integrating varied concepts and data to develop relevant solutions
• Demonstrated ability to participate within an energizing team environment
• Demonstrated ability to successfully interact with other functions on projects that involve negotiation and collaboration with cross-functional peers and more senior management levels.
• Supports and/or coordinates internal and external regulatory audits as required.

Knowledge, Experience and Skills:

• Well qualified candidates with differing levels of experience are also encouraged to apply and may be considered for other positions.
• Excellent communication skills (both verbal and technical) and interpersonal skills are required.
• Demonstrated people management skills required
• In-depth knowledge of Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
• In-depth knowledge of QC principles, concepts, industry practices, and standards
• Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
• Knowledge and experience in commercial Quality Control in a highly regulated manufacturing environments is preferred

Basic Qualifications:

• Bachelor’s or Master’s degree in the analytical chemistry, biochemistry, microbiology, pharmacology or a related discipline from an accredited university.
• Bachelor’s degree will possess 11+ years of relevant biotech/pharmaceutical professional experience.
• Master’s degree will possess 9+ relevant biotech/pharmaceutical professional experience.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes 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.