Sr Research Scientist I - Biologics Drug Product Development
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matter, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Gilead has an opportunity for an experienced candidate in our Biologics Drug Product Development group at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with scientific expertise in protein formulation and drug product process development, oversight of GMP drug product manufacturing, and experience with author/review of CMC sections of regulatory filings (IND/IMPD).Essential Duties and Job Functions:
Knowledge, Experience and Skills:
- Conduct phase appropriate formulation and drug product process development for monoclonal antibody and other recombinant protein modalities (eg, bispecific, fusion, etc.)
- Develop, characterize, and troubleshoot drug product manufacturing unit operations, such as bulk storage freezing / thawing, compounding / mixing, sterile filtration, vial and syringe filling, lyophilization, as well as manual and automated visual inspection
- Conduct technology transfer of protein drug product manufacturing processes to clinical and commercial manufacturing sites, provide person-in-plant support for on-site process development studies and during GMP manufacturing, as well as assist in quality investigations as necessary.
- Represent Biologics Drug Product Development on cross-functional CMC teams
- Demonstrate hands-on technical leadership in the laboratory, oversee experimental/project responsibilities as needed, author and review development summary reports, and contribute to sections of regulatory submissions.
- Be an effective communicator of ideas, project goals and results to team members across functional roles/departments. Proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking. Makes contributions to scientific literature and conferences through publication and presentation of research results.
- Responsible for conducting scientific research for the development of drug candidates or the research support of marketed drugs.
- Degree in Pharmaceutical Sciences, Biology, Biochemistry, Biochemical Engineering or a related scientific discipline and relevant industry experience that demonstrates expertise in drug product development as well as sustained excellence in performance and accomplishments that align to company goals.
- Excellent communication (both verbal and technical) and interpersonal skills are required.
- Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy.
- A minimum of 2 years with Ph.D., or more than 10 years of industry experience with M.S., in protein formulation and drug product process development
- Experience in early stage and/or late stage development of biologics drug products
- Experience authoring regulatory submissions (IND, IMPD)
- Experience working with CMC teams
- Must be able to travel up to 10%
To apply, please submit resume through our website at
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