Sr Associate Scientist
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Sr. Associate Scientist
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.
Specific Job Responsibilities:
The incumbent is responsible for analytical support of Gilead commercial products. Accountabilities cover small molecule and biologics drug substance and drug product including release, stability, investigations, change control and analytical method life cycle management as detailed below:
- Represent Analytical Operations in the CMC project team for assigned commercial products as an analytical operations lead (AOL), provide analytical related support for drug substance and drug product, release and stability, retest period and shelf-life management.
- Accountable to oversee a variety of studies, trend stability data, prepare, review and approve necessary reports. Provide scientifically sound and data-based support of product investigations, impact assessments, and other change controls.
- Work with internal and contract organizations to conduct laboratory investigations as needed to ensure investigations are closed in a timely and compliant manner.
- Provide support to fulfill regulatory commitments and to address regulatory related inquiries for commercial products, including updated stability summary reports for annual report and other required documentation.
- Support routine commercial manufacturing related activities including review and approve release data, participate in audits as needed, and provide support for inspection needs at Gilead and contract sites as required.
Essential Duties and Job Functions:
- Effective communication with both external contract partner and internal cross-functional teams to meet Gilead business objectives.
- Ability to clearly define objectives and bring issues to timely resolution.
- Work with Regulatory & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented.
- Responsible for managing assigned products; well experienced with Empower, LIMS Labware, and Trackwise
- Manage and evaluate laboratory deviation and investigation incidences and determine need for escalation
- Prioritize projects and determine resource constraints as needed.
- Perform investigations as required to support commercial products.
- Serve as the technical and operational resource for the stability related activities.
- Interface with other PDM departments on project issues
- Apply current Good Manufacturing Processes (cGMPs) and Good Laboratory Practices (GLPs) concepts daily
- Review test data and results to ensure compliance with appropriate specifications and protocols
- Lead or participate in group meetings, present data, and prepare information for others to present
- Ability to use statistically based software to perform data trend analysis and assist in investigations.
- Use Microsoft Office software applications to write, revise, and execute protocols, methods, specifications, Standard Operating Procedures (SOPs), and reports.
- 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 & Skills:
- Past experience in analytical drug substance and drug product development (small molecule and biologics), working with various CMOs and testing labs, method development/validation, QC/stability support, conducting investigation, trouble shooting, and regulatory CMC support is preferred
- Experience in biologics drug development and commercial product support in analytical/QC aspects and familiarity with bioassays (including ELISA) is strongly preferred.
- PhD with no post-doctoral assignment
- 11 + years of experience with BA or BS degree in chemistry or Biology
- 9 + years of experience with MS degree in chemistry or Biology
For jobs in the United States:
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 firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
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