Sr. Research Scientist I, Biologics Formulation Process Development, Oceanside CA

Foster City, CA
Aug 28, 2020
Required Education
Position Type
Full time

Sr. Research Scientist I, Biologics Formulation Process Development, Oceanside CA


Sr. Research Scientist I, Biologics Formulation Process Development, Oceanside CA


Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.


Job Description


Sr. Research Scientist I, Biologics Formulation Process Development, Oceanside CA


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 matters, 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 motivated, team-oriented individuals with scientific expertise in formulation and drug product process development as well as clinical and commercial drug product operations related to recombinant proteins.


Reporting to a Senior Director, Biologics Drug Product Development, you will have the opportunity to work in teams for the early and late stage development of our protein molecules.


Specific Responsibilities:


• Lead phase appropriate formulation and drug product process development for monoclonal antibody, recombinant protein, and novel platform programs


• Lead drug product process characterization and PPQ activities for late-stage monoclonal antibody program


• Lead the design and execution of development studies that employ a variety of analytical techniques, including HPLC, capillary electrophoresis, spectroscopy, and visible/subvisible particulates to evaluate formulations and primary drug container closure systems, as well as in-use subcutaneous and intravenous (IV) delivery systems and conditions.


• Lead fill/finish process development and technology transfer of parenteral drug product to clinical and commercial CMO manufacturing sites, provide person-in-plant support, as well as assist in quality investigations as necessary.


• Review GMP batch records and validation reports


• Participate on cross-functional CMC teams


• Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author 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.


• Routinely make decisions affecting direction of project to ensure project timelines are met.


Knowledge, Experience and Skills:


• PhD in scientific or engineering discipline with 3 years of relevant industry experience. BS or MS degree with extensive industry experience.


• Experience with GMP production and batch record review


• Experience with technology transfer


• Experience with late stage product development and BLA filing


• Demonstrated ability to work in a cross-functional environment


• Excellent team work and collaboration skills


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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. 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 for assistance.


For more information about equal employment opportunity protections, please view the ‘EEO is the Law' poster.








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.


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