Sr Research Associate II Biologics Drug Product Development, Technical Operations

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: January 15, 2023

Job Description:

Sr Research Associate II Biologics Drug Product Development, Technical OperationsUnited States - California - OceansideGilead 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 scaleInclusion is one of the company's five core values. That's 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 For Current Gilead Employees and Contractors:Please log onto your Internal Career Site to apply for this job.Job DescriptionSr Research Associate II - Biologics Drug Product Development, Technical OperationsGilead 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 Sciences has an opportunity for an experienced candidate in our Biologics Drug Product Development Technical Operations group at our site in Oceanside, CA. We are seeking motivated, team-oriented individuals with scientific experience in process development and/or manufacturing related to biologics.Essential Duties and Job Functions:

• Understanding of drug product process development for early and late stage biologics.
  • Experience in supporting the tech transfer of parenteral, biologics drug product processes to early phase and late phase clinical manufacturing sites. Reviewing batch records and executing technical operations business and quality processes
  • May provide person-in-plant support during GMP manufacturing, support ongoing manufacturing operations and release, as well as assist in quality investigations as necessary.
  • Trend manufacturing data and evaluating discrepancies
    • May perform process development experiments, scale-down/-up experiments to define drug product process parameters, and to author protocols, summary reports, as well as sections of regulatory submissions.
    • Experience in lyophilized drug product process development, mixing, filtration, and filling process unit operations.
    • Has knowledge pertaining to global cGMP regulatory and guidance documents, such as those from the FDA, EMEA, ICH, US/EU Pharmacopeias, etc., related to drug product manufacturing.
    • Be an effective communicator of ideas, project goals and results in both written and presentation format. The candidate should have the ability to proactively identify issues, make key insights to data, and develop solutions in a collaborative multidisciplinary environment.
    • Candidates should be self-motivated, organized, thrive in team settings and enjoy scientific investigation and thinking, as well as be familiar with the relevant technical literature.Knowledge, Experience and Skills:
      • A minimum of 5+ years' industry experience with BS degree in related scientific discipline or 3+ years' industry experience with MS degree in related scientific discipline.
      • Degree in Pharmaceutical Sciences, Chemical/Biochemical Engineering, Biochemistry or a related scientific discipline and relevant industry experience that demonstrates expertise in process development or drug product technical operations as well as sustained excellence in performance and accomplishments that align to company goals.
      • Excellent communication skills (both verbal and technical) and interpersonal skills are required.
      • Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in providing manufacturing/process development approaches and troubleshooting.To apply, please submit resume through our website at Gilead is an equal opportunity employer.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., Canada, Australia, Singapore, and Hong Kong 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 'Know Your Rights' 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 , Sr Research Associate II Biologics Drug Product Development, Technical Operations, IT / Software / Systems , Oceanside, California