Research Scientist/Senior Manager, Analytical Outsourcing (ONSITE OR REMOTE)

Location
Foster City
Salary
See job description.
Posted
September 24 2021
Ref
R0022423
Position Type
Full Time
Organization Type
Pharma
Job Type
Manager


Research Scientist/Senior Manager, Analytical Outsourcing (ONSITE OR REMOTE)
United States RemoteUnited 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


Research Scientist/Senior Manager, Analytical Outsourcing (Onsite in Foster City, CA or REMOTE)

The Research Scientist/Senior Manager level position in Gilead's Analytical Outsourcing organization will be responsible for managing analytical activities outsourced to third party contract laboratories (CTLs) and contract manufacturing organizations (CMOs). We are seeking candidates with working experience collaborating with outsourced testing laboratories with prior experience in biologics in a pharmaceutical development or quality control setting. This individual will be a key point of contact between Gilead and one or more external partners, responsible for the supplier relationship and performance management.

Specific Responsibilities
  • Manages outsourced analytical and quality control testing activities for biologics bulk drug substance, drug products, and parenterals.
  • Serves as the primary day to day contact to support the relationship between Gilead and assigned contract organizations.
  • Develops strategy for management of outsourced testing needs, considering timelines, risk mitigation and business priorities.
  • Develops, executes and ensures compliance to procedures for outsourced testing oversight.
  • Develops effective strategies for the evaluation and selection of contract organizations.
  • Coordinates with legal and quality assurance groups to establish confidentiality/nondisclosure agreements, service terms and conditions, and quality agreements.
  • Reviews and facilitates approval of proposals, work orders, and changes of scope.
  • Assists in transfer of new projects to various contract organizations.
  • Coordinates testing schedules based on program requirements by interfacing with colleagues in Biologics, Analytical Operations and counterparts in Chemical Development and Formulation/Process Development.
  • Monitors and troubleshoots key outsourced testing activities via email, teleconferences and site visits.
  • Executes strategies that drive effective operational performance and service levels at contract organizations.
  • Communicates risks and delays to management and technical leads on a timely basis
  • Develops metric parameters to evaluate and monitor the performance of contract service providers.
  • Participates in Quality audits as required.
  • Supports strategic business and quality compliance processes and changes by participating in working groups and acting as business process owner for system changes as needed.
  • Provides input for budgeting based on outsourced analytical needs.
  • Negotiate and manage key CTL agreements (MSAs, SOWs, Supply Agreements, Pricing, etc.).
  • Effectively communicate project, performance, and resource issues to management and project teams.


Knowledge & Skills:
  • Able to influence and work well with others in a proactive and constructive manner.
  • Strong communication skills, both verbal and written, with all levels of an organization
  • An independent self-starter with the ability to resolve supplier performance challenges and implement process and/or system improvements.
  • Proven ability to problem solve, build strong relationships, and to organize effectively.
  • Business acumen with an ability to anticipate operational issues and proactively recommend mitigations/solutions.
  • Demonstrated ability to multi-task and to work across multiple multi-national sites and diverse cultures.


Education & Experience

  • A Bachelor's Degree and a minimum of eight (8) years of relevant industry experience, OR a Master's Degree with a minimum of six (6) years of relevant industry experience, OR a PhD.
  • Experience with analytical/QC testing for large molecules/biologics.


Preferred/Desired Experience
  • Direct experience managing supplier relationships and outsourced analytical/QC.
  • Experience with parenteral and/or solid oral dosage forms.


If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg

About Gilead

Gilead Sciences, Inc. is a research-based biopharmaceutical 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

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.

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--Remote/Research-Scientist-Senior-Manager--Analytical-Outsourcing_R0022423





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