Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development

Job Opportunity at Gilead Sciences: Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development

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About Gilead Sciences

At Gilead, we are dedicated to creating a healthier world for everyone. Over the past 35+ years, we have relentlessly tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer. We focus on developing innovative therapies that save lives and ensuring global access to these treatments. Our ongoing mission addresses some of the world’s most challenging health issues, demanding collaboration, determination, and the drive to make a meaningful difference.

Join Our Team

Every Gilead team member is vital in advancing life-changing scientific innovations. Our employees are our greatest asset, and we seek passionate and ambitious individuals ready to make a direct impact. As part of Gilead, you will play a key role in evolving our culture and creating an inclusive, empowering environment where employees can achieve their aspirations.

Job Description

The Senior Research Scientist I, Biologics Pre-Pivotal Formulation and Process Development, will join our collaborative and interdisciplinary CMC development team. Utilizing state-of-the-art technologies and innovative methodologies, you will help advance medicines into clinical trials. The successful candidate will bring relevant technical expertise, contribute to key functional strategies, and lead drug product projects within PDM (Pharmaceutical Development & Manufacturing) teams. Opportunities for career growth are abundant through the acquisition of new skills, experiences, and professional relationships in our dynamic and resource-rich environment.

Responsibilities

• Design and execute formulation and drug product process development packages, including molecular assessments, First-in-Human formulations, manufacturing process development, and clinical evaluations.
• Drive innovation and continuously enhance technical expertise; influence internal and external stakeholders through publications, presentations, and industrial collaborations.
• Apply a deep understanding of analytical, biophysical characterization, or process development techniques; introduce new capabilities and lead by example in lab executions.
• Ensure data integrity and good documentation practices for generating and reviewing reports.
• Collaborate on cross-functional teams to support project strategies and regulatory filings.
• Lead initiative teams striving for business process excellence and scientific innovation.
• Mentor and coach direct reports, if applicable.

Qualifications

• Ph.D. in Pharmaceutical Science, Chemistry, Biochemistry, Chemical Engineering, or a related field with 2+ years, M.S. with 8+ years, or B.S. with 10+ years of industrial experience in biologics CMC development.
• Extensive experience with formulation development, drug product process development, and clinical in-use evaluation for biologics, including monoclonal antibodies, bispecifics, antibody-drug conjugates, fusion proteins, and other formats; experience with IND filings.
• Hands-on lab execution experience and training of junior members.
• Proven track record in technical innovation through publications and presentations.
• Experience in lyophilization cycle development, GMP drug product fill and finish, lab automation, and data science is highly desired.
• Preferable: Experience in a leadership role and working with contracted organizations.

Gilead Core Values

• Integrity: Doing What's Right
• Inclusion: Encouraging Diversity
• Teamwork: Working Together
• Excellence: Being Your Best
• Accountability: Taking Personal Responsibility

Compensation and Benefits

The salary range for this position is $177,905.00 to $230,230.00. Gilead considers various factors when determining base compensation, including experience, qualifications, and geographic location, resulting in variable actual compensation. This role may also be eligible for an annual discretionary bonus, stock-based incentives, paid time off, and a benefits package. Our benefits include company-sponsored medical, dental, vision, and life insurance plans*.

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