Senior Associate Scientist, Tech Services
Senior Associate Scientist, Tech Services
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. Gileads 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
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Sr. Associate Scientist, Technical Services
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 Biologics Technical and Manufacturing Operations at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with expertise in cell culture operations and technical transfer of recombinant proteins. Reporting to the Director of Technical Operations, you will have the opportunity to participate in technology transfer of monoclonal antibody cell culture processes to internal and external manufacturing sites.
Specific Job Responsibilities
- Lead internal Upstream New Product Introductions including; Facility Fit evaluation and Site-Specific Process Description authoring, Master Batch Record review/approval, Change Management ownership, review/approval of Automation updates, deviation resolution as well as providing continuous technical support on the production floor during manufacturing campaigns.
- Provide technical expertise in Upstream technical transfers through an in-depth understanding of scale-up, engineering principles, and associated equipment including; growth rates, specific consumption/production rates, bioreactor design and geometry, power calculations, gas flow/velocities and shear stress
- Support and lead Gilead biologics Upstream technical operations by enabling timely and successful technology transfer of upstream manufacturing processes to external Contract Manufacturing Organizations (CMOs)
- Ensure that appropriate process data are recorded and analyzed to monitor run-to-run consistency for Upstream operations across internal and CMO production campaigns
- Work closely with and lead cross-functional teams including Gilead's Biologics Manufacturing, Process Development, Engineering, Supply Chain and Quality to provide routine Technology Transfer progress updates for internal and external technical teams.
- Collaborate with Gilead's Biologics Outsourcing group to ensure timelines, deliverables, and business operations are aligned and met in accordance with the Technology Transfer of molecules to CMOs.
- Serve as a subject matter expert during cell culture operations; provide technical troubleshooting and investigative support during internal and external manufacturing runs.
- Contribute to and/or lead technical investigations of process deviations and assessment of impact on product quality
- Identify areas for improvement or optimization, lead implementation of best practices, and present data to applicable departments on the outcome of investigations or optimization initiatives
- Coordinate or support implementation of new equipment or technologies internally and at CMOs.
- Support and drive yield improvements and process efficiencies
- Contribute and/or lead cross-functional projects with limited direction
Essential Duties and Job Functions:
- Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs).
- Demonstrates excellent verbal, written and interpersonal communication.
- Works on non-routine to complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before acting.
Knowledge & Skills
- Prior experience in an Upstream Technical Operations/MSAT role including technology transfer of biologics to contract manufacturing sites.
- In-depth understanding of cGMP requirements for commercial manufacturing, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections.
- Knowledge of cGMPs and validation requirements in all clinical phases.
- Experience with monoclonal antibody cell culture production including equipment and operations from thaw through harvest.
- Biologics experience with alternative modalities, expression systems, antibody design variants, and/or viral vaccines is a plus.
- Leverage technical expertise to lead investigations/author reports to support close-out of deviations and troubleshoot process excursions/issues for cell culture operations.
- Must be able to work effectively in cross-functional teams.
- Must demonstrate excellent technical writing skills.
Education & Experience
- A Bachelor's Degree in a relevant scientific discipline and a minimum of six (6) years of experience OR a Master's Degree in a relevant scientific discipline with a minimum of five (5) years of experience.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.yello.co/external/form/24a8oU4jF5UL3CKq7lO_Cg
Gilead Sciences, Inc. is a research-based biopharmaceutical 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.
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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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
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