Biologics Analytical Research Specialist
2 weeks ago
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we are dedicated to fostering a healthier world for everyone.
For over 35 years, we have addressed critical health issues such as HIV, viral hepatitis, COVID-19, and cancer, tirelessly working to develop therapies that enhance lives and ensure global access to these treatments.
We remain committed to combating the most significant health challenges worldwide, and our mission relies on collaboration, determination, and an unwavering commitment to making a difference.
Every member of Gilead's team plays an essential role in the discovery and development of transformative scientific innovations.Our workforce is our most valuable asset as we strive to achieve our ambitious goals, and we are seeking the next generation of passionate and driven individuals ready to make a meaningful impact.
We believe that every employee deserves an exceptional leader. People Leaders are fundamental to the employee experience at Gilead and Kite.As a people leader now or in the future, you will be instrumental in evolving our culture and creating an environment where every employee feels included, developed, and empowered to reach their aspirations.
Join Gilead and help create possibilities, together.Position Overview:
Gilead Sciences is looking for a skilled and motivated Research Scientist to join our Pre-Pivotal Biologics Analytical Operations team.
They will have opportunities for professional growth through the acquisition of new skills, experiences, and professional relationships in a dynamic and resource-rich environment.
Key Responsibilities:
- Design, develop, and implement bioassay (potency) methods that replicate the mechanism of action for biologic therapies.
- Troubleshoot method-related challenges, enhancing and optimizing as necessary.
- Organize, prepare, and maintain critical reagents with suitable system suitability criteria.
- Author method development reports, test procedures, and relevant method transfer documents.
- Present findings to cross-functional internal and external teams.
- Oversee and advise on data generation/data integrity, ensuring compliance and analytical excellence from both internal and outsourced testing at contract organizations.
- Maintain strong relationships with key stakeholder functions and collaborate cross-functionally with colleagues in Research, Clinical Development, 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 contribute to the preparation of INDs and patents in a relevant scientific discipline.
Qualifications:
- Ph.D. in a relevant scientific discipline OR M.S. with 6+ years OR B.S. with 8+ years of experience in Analytical Chemistry or related fields of industrial experience in biologics analytical development.
- Familiarity with FDA and ICH guidelines related 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 - understanding the business value of diverse teams, modeling inclusion, and embedding the value of diversity in team management.
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:
$154,000 - $199,000. Gilead considers various 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:
- 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.
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 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 opinions.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job
Summary Location:
United States - California - Foster City Type: Full time
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