Gilead Sciences, Inc

Job Description The Senior Research Scientist II, Analytical Development Pre-Pivotal Biologics will be responsible for development of analytical methods and strategies for monitoring and control of potency and process related impurities including method development, qualification, and transfer for Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II).. Responsibilities: Establish and maintain a state of the art analytical development laboratory that will allow for rapid process development support and development of control system and characterization methods to determine potency by ELISA, as well as process related impurities including host cell protein, host cell DNA, affinity resin materials, etc.. Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections.. Qualifications: Ph. D. with 5+ years experience OR M.S. with 9+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.. Extensive experience with development and validation of ELISA based methods and well versed in separation (HPLC, CE, iCIEF) and/or mass spectrometric technologies/data interpretation.

senior research scientist ii

For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams. Every member of Gilead’s 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 we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together. Job Description The Senior Research Scientist II, Analytical Development Pre-Pivotal Biologics will be responsible for development of analytical methods and strategies for monitoring and control of potency and process related impurities including method development, qualification, and transfer for Gilead’s biologics entities during pre-pivotal phases of development (pre-clinical, phase I/II). He/She will also be responsible for developing control strategies for biologic drug substance and drug product as well as analytical regulatory strategies to enable successful regulatory filings. Responsibilities: Establish and maintain a state of the art analytical development laboratory that will allow for rapid process development support and development of control system and characterization methods to determine potency by ELISA, as well as process related impurities including host cell protein, host cell DNA, affinity resin materials, etc. Make decisions between establishing in-house technologies or testing via contract organizations. Oversee data generation / data integrity and ensure compliance and analytical excellence from internal and outsourced testing at contract organizations. Lead characterization, analytical control, and regulatory strategies for biologic drug substance and drug product. Author associated test procedures, protocols, reports, and regulatory filings. Lead analytical method development, validation, and transfer activities in support of PDM (Pharmaceutical Development & Manufacturing) project team needs. Lead a team of analysts with a focus on analytical excellence as well as teamwork and collaboration across all PDM organizations. Provide leadership and direction to members of his/her team within the Pre-Pivotal Analytical Development and QC Operations organization. Support regulatory filings by authoring/reviewing CMC regulatory sections of IND/INDa; support associated agency interactions and product-related inspections. Evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing. Serve as, and/or coach employees as, analytical lead for PDM pre-pivotal biologics programs to ensure successful IND/INDa applications. Ensure strong relationships with key stakeholder functions including 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. Qualifications: Ph.D. with 5+ years experience OR M.S. with 9+ years experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities. Extensive experience with analytical method development, validation, and control strategies of biologic products. Extensive experience with development and validation of ELISA based methods and well versed in separation (HPLC, CE, iCIEF) and/or mass spectrometric technologies/data interpretation. The salary range for this position is: $191,335.00 - $247,610.00. 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*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. 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 ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' 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.

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