Sr. Research Associate II, Analytical Operations - Method Validation Group

Location
Foster City
Salary
See job description.
Posted
August 31 2021
Ref
R0020391
Position Type
Full Time
Organization Type
Pharma


Sr. Research Associate II, Analytical Operations - Method Validation Group
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

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Job Duties & Functions:
  • Write and execute study plans and validation protocols.
  • Independently plans and executes that support research, development and GMP method validation activities.
  • Execute laboratory techniques such as water content, dissolution, disintegration, LC, GC, DSC, particle size, XRPD, infrared and UV-Vis spectroscopy
  • Review data to ensure compliance according to test methods, specifications, and protocols.
  • Participate in user requirements, assessment and validation of 21 CFR Part 11 software and/or customized software plus authoring SOPs, User Manuals and Training Documentation.
  • Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts.
  • Author and revise test methods, technical reports, SOPs and relevant documents.
  • Participate in meetings, present and interpret data.
  • Conduct test analysis of drug substance and drug product samples based on written procedures.
  • Work with Regulatory Affairs & Quality Assurance to ensure that all applicable FDA regulations are followed.


Essential Education, Experience & Skills:
  • BS or BA degree in Chemistry, Biology or relevant science majors with 4+ years or M.S. degree with 2+ years of relevant experience in biotech/pharmaceutical experience
  • Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.
  • Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments.
  • Strong working knowledge of cGMP and quality control (QC).
  • Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
  • Knowledge in Compliance System (e.g. Trackwise and GVault)
  • Demonstrates the ability to clearly and concisely present analysis results to different stakeholders.
  • 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.


Preferred Experience:
  • Biologics experience is a plus

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 careers@gilead.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.
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To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/Sr-Research-Associate-II--Analytical-Operations---Method-Validation-Group_R0020391-1





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