Scientist, Analytical Ops job opportunity at Gilead Sciences.

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DatePosted 30+ Days Ago bot
Gilead Sciences Scientist, Analytical Ops
Experience: Highly Experienced
Pattern: full-time
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Analytical Ops

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degreeAssociate
loacation United States - California - Foster City, United States Of America
loacation United States ..........United States Of America

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.   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.   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   Job Description Gilead Sciences (Foster City, CA) is seeking a talented and highly motivated Scientist to join our Pre-Pivotal Biologics Analytical Development 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/representative 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:  Lead and support analytical characterization activities for pre-pivotal (Toxicology, Phase I/II) biologic molecules.  Identify molecule critical quality attributes, propose and justify analytical control strategies, author relevant regulatory filings for biologic drug substance and drug product. Lead the development of advanced extended characterization methods utilizing state-of-the-art mass spectrometry technologies including (but not limited to) Native LC-MS, CE-MS, MD-LC-MS, affinity LC-MS, and automated high-throughput LC-MS/MS, for pre-pivotal (Phase I/II) biologics. Develop analytical methods to be used for molecule characterization and/or release testing (using HPLC-UV, CE, HPLC-FLR, iCIEF, HPLC-CAD, etc .).  Author associated method development reports, test procedures, validation protocols and reports. Proactively evaluate and implement state of the art technologies to drive innovation in Analytical Development and testing. 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. Presents research findings and recommendations to senior staff, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation of INDs, and patent filings Qualifications:  Ph.D. with 3+ years or M.S. with 6+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development. Advanced expertise and hands-on experience with LC-MS based biologics characterization and data analysis to support CMC process development Experience with analytical method development, validation, and control strategies of biologic products (e.g. HPLC, CE-SDS. iCIEF, LC-MS/MS, intact/reduced/sub-units mass, gel electrophoresis, etc ). Familiar with FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.  Ability of building 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, modelling 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: $146,540.00 - $189,640.00. 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: 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 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 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.

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