This website uses cookies to ensure you get the best experience. Learn more
Gilead

Manager/ Sr. Associate Scientist, Analytical Outsourcing & Stability

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Responsibilities:

  • Manages and leads a group of 5-6 analytical staff in the AOS department to provide high quality support of GMP release and stability testing for clinical drug substances and drug products in various dosage forms
  • Oversees day-to-day GMP laboratory operations including organizing and prioritizing daily tasks, monitoring progress, providing guidance for troubleshooting, and writing performance reviews
  • Provide broad based GMP analytical expertise and counsel to and on behalf of the AOS organization
  • Provides leadership, management, and training for AOS staff
  • Review and approve quality records (laboratory investigations, deviations, CAPAs, and change managements) and procedures (SOPs, test methods, protocols, and reports)
  • Lead and coordinates AOS and cross-functional projects, lab investigations, and change managements
  • Works with external vendors/contractors to ensure testing or other related activities are completed in a timely fashion
  • Works with QA to ensure all applicable cGMP regulations are followed and documented
  • Work with analytical project leads and method validation group to ensure QC-friendly test methods are established to support release and stability testing
  • Work with Laboratory Operations group to ensure that laboratory instruments are properly calibrated and maintained with appropriate documentations
  • Work with Facilities to ensure compliance with all OSHA regulations, including management of hazardous materials

Education Requirement:

  • B.S or B.A degree in Chemistry or Biology with 9+ years of relevant experience in an analytical GMP regulated environment
  • M.S. degree in Chemistry or Biology with 7+ years of relevant experience in an analytical GMP regulated environment

Required Experience:

  • Prior experience managing people is required. (1+ years of experience in a direct line management role)
  • Must have prior working knowledge of cGMPs, quality control (QC), pharmacopeias, and regulatory requirements for GMP laboratories in pharmaceutical industry

  • Extensive hands-on experience with analytical techniques such as UPLC/HPLC, Dissolution, GC, Thermogravimetric DSC/TGA, KF titrations, particle size, and disintegration

Additional Experience:

  • Critical thinking skills and ability to solve complex issues where analysis required an in-depth assessment of various factors and good judgement in making routine recommendations
  • Demonstrated ability to assess risk in day-to-day operations and make appropriate decisions
  • Excellent leadership and interpersonal skills and ability to work effectively with direct reports, peers, and managers
  • Experience of supervising and interacting with people from a wide range of skill levels and experience
  • Excellent verbal and written communication skills


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.

Apply Now

Share this