Sr. Research Associate I - Method Validation

Sr. Research Associate I - Method Validation

Foster City, CA

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.

Essential Duties and Job 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.
  

Knowledge and Skills:

• 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.
  
• Biologics experience is a plus
  
• 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.
  

Minimum Qualifications:

• BS or BA degree in Chemistry, Biology or relevant science majors with 2+ years; or M.S. degree with 0+ years of relevant experience in biotech/pharmaceutical experience/
  

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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.

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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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