Research Associate, Process Development
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
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to apply for this job.Job DescriptionResearch Associate - Protein Purification Process 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 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 Substance Process Development group at our Oceanside facility in Southern California. We are seeking motivated, team oriented individuals with scientific expertise in process development as well as pre-clinical and clinical operations related to recombinant proteins. Reporting to a Research Scientist in Purification Process Development, you will have the opportunity to work and direct teams for the early and late stage clinical development of our protein molecules.Specific Responsibilities and Job Functions:
- Plan and execute experiments supporting development, characterization and troubleshooting of drug substance manufacturing unit operations such as centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal with limited supervision.
- Support Research material generation requests during molecular assessment with high throughput purification
Knowledge, Experience and Skills:
- Collaborate with Development Biologics Technical Operations in technology transfer from process development to clinical and commercial GMP manufacturing, including definition of bill of materials, batch record drafting/review, and discrepancy resolution. Serves as process development representative during purification operations, provides technical troubleshooting and identifies opportunities for future process and equipment improvements.
- Author and review GMP and non-GMP technical documentation (batch records, SOPs, validation protocols & reports; process characterization protocols and reports)
- Participates in internal and cross-functional meetings and presents results of work, interprets data, and draws conclusions regarding presented material and nature of work
- Demonstrates good verbal communication and interpersonal skills to provide insight into the processes used to achieve results of assigned tasks
- Demonstrates ability to recognize anomalous and inconsistent results and interpret experimental outcomes and proactively seek out senior personnel to discuss potential solutions to problems
- Comply with safety and environmental rules and regulations applicable to the operations.
- Have working understanding of downstream process development and scale up including centrifugation, normal flow filtration, chromatography operations, tangential flow filtration, and virus inactivation/removal. The ability to demonstrate a significant level of hands on experience in several of these areas is a plus.
- A broad understanding of purification process development for monoclonal antibodies, recombinant protein proteins and/or other biologics modalities is a plus
- Prior experience in analytical SEC/HPLC and HCP ELISA is beneficial, but not required.
- Familiarity with Pilot Plant and GMP manufacturing operation concepts including sale-up, technology transfer, documentation review and technical troubleshooting is preferred.
- Effective verbal/written communication skills and interpersonal skills.
- Demonstrated ability to work in a collaborative environment with a problem-solving spirit.
- Ability to proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
- Be self-motivated and organized, familiar with relevant literature, and enjoy scientific investigation.
- 0+ years of experience with BS degree in a relevant scientific discipline.
To apply, please submit resume through our website at www.gilead.com
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