Senior Associate Scientist, External Quality Analytical Oversight

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

AtGileadour pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to a Senior Associate Scientist you will contribute to QC procedures across Gileads commercial manufacturing network ensuring global cGMP Associate Scientist collaborates with cross-functional teams fosters a culture of continuous improvement and supports the QC team for timely project completion and regulatory compliance.

This is a site-based position (up to 5x a week) in Foster City CA.

Key Responsibilities

The Senior Associate Scientist in External Quality Analytical Oversight role supports external commercial QC through hands-on execution of activities and processes related to data review documentation method lifecycle support and continuous improvement. Working within established procedures and with guidance from senior colleagues the role helps ensure accurate timely and compliant QC deliverables.

Focus Areas

• Perform review of external QC laboratory data for commercial release and stability testing including contract testing laboratory (CTL) Certificates of Analysis (CoA) stability reports and supporting documentation in accordance with Gilead procedures for oversight of contract laboratory data.
• Perform data-based review of CTL raw data packages including verification of method conditions sample and standard preparation reference standard use system suitability representative chromatograms and calculation accuracy; support Level 3 on-site data reviews as assigned.
• Use lab information management system (LIMS) to verify accurate transcription of results against CTL documents and specifications complete test- and sample-level review and authorization review audit trails and generate provisional CoAs Stability Summary Reports and Analytical Reports.
• Use electronic documentation management system to retrieve review and accept CTL CoAs stability reports raw data packages specifications and test methods; maintain document metadata and workflows and document data review findings and discrepancies.
• Partner with QC Leads CTLs and QA to resolve data discrepancies request and track CTL corrections and ensure data review is completed within required turnaround times.
• Identify document and escalate data review findings including atypical results trends and data integrity or ALCOA concerns; support related laboratory investigations (OOS/OOT/OOE) deviations and CAPAs.
• Compile and report QC data-related metrics maintain review and batch release trackers and communicate status turnaround times and outstanding issues.
• Coordinate SAP specification authoring and updates with designated authors and QC stakeholders tracking completion and confirming alignment with approved specifications.
• Contribute to continuous improvement of data review processes and electronic system workflows including authoring or revising SOPs work instructions and job aids and supporting system changes and user testing.

Experience:

You have:

• Experience with Commercial Quality Control analytical development or a related laboratory environment.
• Working knowledge of GMP principles data integrity expectation of lab data and applicable procedures and standards in the US and internationally.
• Must be able to develop and improve complex concepts techniques and standards and new applications based on quality principles and theories.
• Demonstrated ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gileads GMP policies.
• Demonstrated the ability to influence process and outcomes across functions.

Requirements:

• BS degree in Chemistry Biochemistry or related field with 5 years of relevant experience OR
• MS degree in Chemistry Biochemistry or related field with 3 years of relevant experience
• Knowledge and experience in commercial quality control.
• Stays ahead of shifting trends in industry.
• Ability to think critically analyze information and work independently on defined assignments while seeking guidance when needed.
• Strong organizational planning and attention-to-detail skills.
• Effective verbal and written communication skills and a collaborative working style.

Leader Accountabilities:

• Create Inclusion -knowingthe business value of diverse teams modeling inclusion and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills experience aspirations and potential of their employees and coach them on current performance and future potential. They ensure employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $117895.00 - $152570.00. Gilead considers a variety of factors when determining base compensation including experience qualifications and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus discretionary stock-based long-term incentives (eligibility may vary based on role) paid time off and a benefits package. Benefits include company-sponsored medical dental vision and life insurance plans*.

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.

For more information about equal employment opportunity protections please view the Know Your Rights poster.

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

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 apply via the Internal Career Opportunities portal in Workday.

Required Experience:

Senior IC