Associate Scientist, Analytical Ops
Associate Scientist, Analytical Ops
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
- Lead cross-functional projects to ensure method validation activities are completed timely to support clinical use
- Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts
- Support internal and regulatory inspections
- Perform day-to-day operations to support product development; feasibility and validation of analytical methods for clinical projects and method transfer activities.
- Provide leadership, mentoring, and training for junior staff.
- Write and execute study plans, validation protocols and reports.
- Draft and review test methods, SOPs and compliance documents.
- Execute laboratory techniques such as water content, dissolution, UPLC, GC, particle size, and UV-Vis spectroscopy.
- Review data to ensure compliance according to test methods, specifications, and protocols.
- Lead investigations with team members and Analytical Lead.
- Data interpretation, design of experiments, and presentation of data to cross-functional colleagues
- Knowledge in Lab information System and Part 11 software (e.g. Empower, LES, ELN, SDMS, and LIMS) to ensure data integrity and documentation are in compliance.
- Knowledge in Compliance System (e.g. GTrack, GxP Learn, EDMS and RDMS)
- Work with Regulatory Affairs & Quality Assurance to ensure that all applicable FDA regulations are followed and properly documented.
- Work with facilities management to ensure compliance with all OSHA regulations, including management of hazardous material.
Required Experience and Education:
- MS degree with 6+ years' experience or BS degree with 8+ years' industry experience
- Experience validating test methods for biologic and biopharmaceutical products
- Strong knowledge and understanding of cGMP, quality control (QC), and regulatory requirements for GMP laboratories in pharmaceutical industry
- Hands-on experience with analytical techniques such as UPLC/HPLC, Dissolution, KF titrations, particle size, disintegration is a plus.
- Knowledge of software such as Empower, ELN, LIMS and Trackwise, etc.
- Critical thinking skills and ability to solve moderately complex problems and good judgement in making recommendations
- Strong working knowledge of industry standards and regulatory requirements pertaining to pharmaceutical experience in method development and validation
- Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
- Excellent verbal and written communication skills
- Ability to work independently and as part of a team with internal and external partners, self-motivation and adaptability
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 email@example.com 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:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Associate-Scientist--Analytical-Ops_R0016388-2
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