Scientist, Analytical Operations
Gilead Sciences, Inc.
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**
We are seeking a talented and highly motivated **Research Scientist** to join our **Pivotal and Commercial Biologics Characterization** team within **Biologics Pivotal and Commercial Analytical Development** . This role requires broad experience in analytical development across all stages—from early development to commercial launch—as well as regulatory filing experience with the FDA and EMA. A deep understanding of technologies used in the characterization of biological products is essential.
The ideal candidate will be driven to contribute to the research and development of biologics addressing unmet medical needs. This includes biochemical characterization and the development of novel analytical methods to support both clinical and commercial programs.
**Key Responsibilities:**
+ Define excipient and process reagent testing and control strategies across the late-phase biologics portfolio, with a focus on product stability.
+ Drive continuous improvement of excipient strategies.
+ Support the design, justification, and execution of end-to-end control strategy development through proactive definition of product quality targets.
+ Deliver high-quality work packages to support Pivotal IND and marketing applications.
+ Present findings to internal and external cross-functional teams.
+ Author analytical test methods, study protocols, and technical reports.
+ Independently plan and execute experiments to support development and investigations.
+ Collaborate across Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development, and Technical Development to ensure timely delivery and successful commercialization of the late-stage biologics portfolio.
+ Drive adoption of novel and state-of-the-art characterization technologies and approaches.
**Basic Qualifications:**
+ BS degree in Biochemistry or a related discipline with at least six (6) years of experience OR
+ MS degree in Biochemistry or a related discipline with at least four (4) years of experience,
+ Strong knowledge of mass spectrometry, experimental design, and assay development.
+ Excellent communication skills (verbal, technical writing, and interpersonal).
+ Strong organizational and planning skills.
+ Ability to think critically and creatively, work independently, and resolve problems using appropriate resources.
**Preferred Qualifications:**
+ PhD in Biochemistry or a related discipline with 0+ years of experience
+ Subject matter expertise in establishing comprehensive control strategies for biologics products.
+ Familiarity with technologies such as:
+ Mass spectrometry
+ Analytical ultracentrifugation (AUC)
+ Size exclusion chromatography (SEC)
+ Reversed phase chromatography
+ Ion exchange chromatography (IEX)
+ Capillary gel electrophoresis (CGE)
+ Light scattering techniques (DLS, MALS)
+ Molecular analysis
+ Knowledge of FDA and ICH guidelines related to registration, quality, and compliance for drug substances and drug products.
+ Experience with mass spectrometry analysis software (Protein Metrics, Thermo BioPharma Finder, Skyline).
+ Proficiency in data analysis and visualization tools (Python, R, JMP, Spotfire).
The salary range for this position is: $133,195.00 - $172,370.00. 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' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
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.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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