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Associate Director / Sr Research Scientist II - DP Process Development

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

Job Description:

Associate Director / Sr Research Scientist II - DP 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
Inclusion 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 Description

Associate Director / Sr Research Scientist II - Drug Product 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 Product Development group at our Oceanside facility in Southern California. We are seeking a motivated, team-oriented individual with scientific expertise in protein formulation and drug product process development, oversight of GMP drug product manufacturing, and experience with author/review of CMC sections of regulatory filings (IND/IMPD/BLA).

Essential Duties and Job Functions:

  • Lead early and late-stage biologics drug product formulation and fill/finish process development / characterization, of different modality products (mAbs, bispecifics, ADC, and hybrid molecules) in vials, pre-filled syringes and cartridges
  • Develop and characterize drug product manufacturing unit operations, such as bulk storage freezing / thawing, compounding / mixing, sterile filtration, vial and syringe filling, lyophilization and manual / automated visual inspection.
  • Lead the design and execution of development studies to evaluate formulations and primary container closure systems, as well as in-use subcutaneous and intravenous (IV) delivery systems and conditions.
  • Represent Biologics Drug Product Development in cross functional CMC teams responsible for all aspects of drug product from preclinical through commercialization
  • Collaborate with clinical and commercial technical operation teams to successfully conduct drug product manufacturing site selections, technology transfer and manufacturing of early and late-stage products.
  • Manage a team of scientists and engineers to advance programs at different stages and technology development activities.
  • Participate and lead cross-functional teams working effectively in a highly matrixed team environment to drive continuous improvement in process to reduce COGM and to improve overall process efficiency
  • Author and review documents, technical protocols, reports, and regulatory sections in support of INDA and marketing application submissions.
  • Serve as subject matter expert in biologics drug product development and help drive best practices and technology advancements. Drive continuous improvement through technology innovation.
  • Be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking.
  • Lead, motivate, and develop the people in their group.
    Knowledge, Experience and Skills:
    • 7+ years of experience with Ph.D. in a related scientific discipline or BS/MS with extensive industry experience in protein formulation and drug product process development
    • Outstanding knowledge and hands-on experience in early and late-stage development of biologics drug products which includes formulation and fill/finish process development, process characterization, technical transfers to manufacturing sites, process performance qualification (PPQ) and regulatory authoring (INDA, BLA/MAA)
    • Experience with multiple modalities mAbs, bispecifics, ADCs, and hybrid molecules
    • Experience working with cross-functional CMC teams
    • Strong communication skills and ability to influence cross-functional teams
    • Managerial experience in support of drug product development and commercialization activities
      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 '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 , Associate Director / Sr Research Scientist II - DP Process Development, Executive , Oceanside, California

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