Scientist, Biologics CMC Analytical Development
Job Location:
Foster, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
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
Scientist Biologics CMC Analytical Development
Gilead Sciences (Foster City CA) isseekinga talented and highly motivatedScientist to join ourPDMPre-Pivotal Biologics AnalyticalDevelopmentgroup. Our collaborative and interdisciplinarydevelopmentteamutilizesstate-of-the-arttechnologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected toserve as the analyticalleadonPDM (Pharmaceutical Development & Manufacturing) project teams. You will have opportunities for career growth through acquisition of new skills experiences and professional relationships in a fast-paced and resource-rich environment.
Responsibilities:
LeadCMCAnalyticalTeamforPrePivotalBiologics
Serve as theCMCanalyticalsub-teamlead to define potential critical quality attributes (pCQAs)establishphase-appropriatecontrol strategies and enable characterization of biologics supportingToxicology and early clinical development (Phase I/II).
Drive Analytical Method Development & Implementation
Design develop and deploy robust analytical methods for product characterization and release/stability testing using advancedtechnologies (e.g.HPLC-UV/FLR/CAD/ELSD CE/iCIEFNative LC-MS CE-MS MD-LC-MS affinity LC-MS). Author method development reports test procedures and associated technical documentation.
Advance Innovation in Analytical Development
Evaluate and implementstateofthearttechnologies and emerging approaches to enhance analytical capabilities improve efficiency and enable deeper molecular understanding.
Ensure Data Integrity and Operational Excellence
Provide technical oversight of internal and external analytical activities ensuring high-quality data generation compliance with regulatory expectations and strong data governance across CRO/CDMOpartnerships.
CollaborateCrossFunctionallyto Drive Program Success
Partner closely with Research Process Development Clinical DevelopmentSafety and Program Strategy teams to provide strategic and technical input across the product lifecycle.
Contribute to Regulatory and Scientific Deliverables
Present findings to senior leadership author technicalreportsand manuscripts and support regulatory submissions (e.g.IND/IMPD/CTA) and intellectual property filings.
Qualifications:
Ph.D. with3 years
or
M.S. with6 years in Analytical Chemistry or related fieldswith a focus on biologics(therapeutic proteins)CMCanalytical development.
Provenexperienceleadingearly-stage CMC analytical programs supporting pre-pivotal development (Toxicology Phase I/II) and regulatory submissions (IND/IMPD).
Strong experience in analytical method developmentqualification/validation and control strategy for biologics (e.g. HPLCiCIEFCELCMS based biologics characterization and data analysis).
Working knowledge of FDA/ICH regulatory expectations for drug substance and drug product quality and compliance.
Demonstrated ability to collaborate effectively across CMC and crossfunctional teams.
Familiarity with digital and data capabilities including lab automation data governance computer system validation and knowledge management.
Commitment to fostering inclusive highperforming teams recognizing the value of diverseperspectives.
Gilead Core Values
Integrity (Doing Whats Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking PersonalResponsibility)
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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 theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
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:
IC
About Company
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensu ... View more
