Gilead Sciences, Inc.
Research Scientist - Pre-Pivotal Biologics Analytical Operations
Gilead Sciences, Inc., San Mateo, California, United States, 94409
Research Scientist - Pre-Pivotal Biologics Analytical OperationsUnited 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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Job Description
Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Research Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our collaborative and interdisciplinary development team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to serve as the analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.
Responsibilities:
Design, develop and execute bioassay (potency) methods to mimic the mechanism of action for biologic therapies.Troubleshoot method related issues (ELISA, qPCR, etc), improve and optimize as needed.Organize, prepare, and maintain critical reagents with appropriate system suitability criteria.Author associated method development reports, test procedures, and relevant method transfer documents.Support analytical characterization activities for pre-pivotal (Phase I/II) biologic molecules including comparability studies. Hands-on experience with immunoassays, cell-based assays, and Biacore is strongly preferred.Present findings to cross-functional internal/external teams.Oversee and advise data generation/data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.Provide technical support to internal and external cGMP manufacturing operations.Present research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and author/contribute to the preparation of INDs and patent filings.
Qualifications:
Ph.D. in a relevant scientific discipline OR M.S. with 6+ years OR B.S. and 8+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.Strong experience with analytical method development, validation, and control strategies of biologic products (e.g. potency by ELISA, bioassay, process-related impurities including host cell protein, host cell DNA, and affinity resin materials).Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.Ability to build strong collaborations with other CMC functions.Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection.Create Inclusion - knowing the business value of diverse teams, modeling inclusion and embedding the value of diversity in the way they manage their teams.
Gilead Core Values:
Integrity (Doing What's Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)
The salary range for this position is: $154,020.00 - $199,320.00. 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.
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.#J-18808-Ljbffr
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. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Job Description
Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Research Scientist to join our Pre-Pivotal Biologics Analytical Operations group. Our collaborative and interdisciplinary development team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic. The successful candidate is expected to serve as the analytical lead on PDM (Pharmaceutical Development & Manufacturing) project teams. S/he will have opportunities for career growth through acquisition of new skills, experiences, and professional relationships in a fast-paced and resource-rich environment.
Responsibilities:
Design, develop and execute bioassay (potency) methods to mimic the mechanism of action for biologic therapies.Troubleshoot method related issues (ELISA, qPCR, etc), improve and optimize as needed.Organize, prepare, and maintain critical reagents with appropriate system suitability criteria.Author associated method development reports, test procedures, and relevant method transfer documents.Support analytical characterization activities for pre-pivotal (Phase I/II) biologic molecules including comparability studies. Hands-on experience with immunoassays, cell-based assays, and Biacore is strongly preferred.Present findings to cross-functional internal/external teams.Oversee and advise data generation/data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations.Maintain strong relationships with key stakeholder functions and work cross-functionally with colleagues in Research, Clinical Development, and Clinical Supply Management and Program Strategy Teams by providing technical and strategic input.Provide technical support to internal and external cGMP manufacturing operations.Present research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and author/contribute to the preparation of INDs and patent filings.
Qualifications:
Ph.D. in a relevant scientific discipline OR M.S. with 6+ years OR B.S. and 8+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.Strong experience with analytical method development, validation, and control strategies of biologic products (e.g. potency by ELISA, bioassay, process-related impurities including host cell protein, host cell DNA, and affinity resin materials).Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.Ability to build strong collaborations with other CMC functions.Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection.Create Inclusion - knowing the business value of diverse teams, modeling inclusion and embedding the value of diversity in the way they manage their teams.
Gilead Core Values:
Integrity (Doing What's Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)
The salary range for this position is: $154,020.00 - $199,320.00. 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.
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.#J-18808-Ljbffr