Senior Associate II, Tech Services - Downstream

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: November 19, 2022

Job Description:

Senior Associate II/Technical Services PurificationGilead has an opportunity for an experienced candidate in Biologics Drug Substance Development at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with expertise in purification/downstream operations and technical transfer of recombinant proteins. Reporting to a Sr Associate Scientist in Biologics 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 Responsibilities

• Support internal Downstream New Product Introductions including; Facility Fit evaluation, 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
• Support Gilead biologics purification 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 Downstream operations across internal and CMO production campaigns
• Work closely with Gilead's Biologics Quality and Operations teams and provide routine Technology Transfer progress updates to 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.
• 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 Knowledge & Skills
  • Demonstrates a commitment to compliance and a thorough knowledge of current Good Manufacturing Practices (cGMPs).
  • Demonstrates excellent verbal, written and interpersonal communication.
  • Able to work effectively in cross-functional teams.
  • Demonstrates excellent technical writing skills.
  • Works on non-routine to somewhat complex problems, projects, and assignments where analysis of data, procedures or operations requires evaluation of multiple factors before acting.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.
    • Understanding of cGMP requirements for clinical and commercial manufacturing, data capture/management and process monitoring/trending.
    • Experience with monoclonal antibody purification production including equipment and operations, including chromatography, virus retentive filtration, and tangential flow filtration.Preferred Experience
      • Biologics experience with alternative modalities, expression systems, antibody design variants, and/or viral vaccines.
      • Process validation and Process Performance Qualification (PPQ)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: About GileadGilead 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.For jobs in the United States: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.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. For more information about equal employment opportunity protections, please view the EEO is the Law' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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.For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.
        
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Keywords: Gilead Sciences, Inc., Oceanside , Senior Associate II, Tech Services - Downstream, Other , Oceanside, California