Sr. Research Scientist II

Company: Gilead Sciences, Inc.
Location: Oceanside
Posted on: May 21, 2023

Job Description:

Sr. Research Scientist II page is loaded Sr. Research Scientist II Bewerben locations United States - California - Oceanside time type Full time posted on Vor 2 Tagen ausgeschrieben job requisition id R0036186 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job DescriptionGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, CaliforniaRole Summary: The successful candidate will be responsible for managing a team responsible for method validation and transfer of potency methods for late-stage biologics programs. In this capacity, the candidate will work closely with potency assay development, quality control, quality assurance, external clinical testing laboratories, and regulatory. Role and Responsibilities:

• Lead potency technology transfer team and responsible for potency and residual method validation and transfer for late-stage biologics programs. Manage execution in contract testing laboratories.
• Serve as a potency subject matter expert in the commercial Biologics team, working closely with external analytical outsourcing team and quality team to manage the project timeline and troubleshoot potency and residual methods. Demonstrates ability to recognize anomalous and inconsistent results and perform quality event investigation.
• Drive improvement process for the bioassay team and enhance working relationships with internal and external partners.Essential Duties and Job Functions:
  • Hands-on technical experience in developing, validating, and transferring potency and residual methods. -
  • Manage execution of method validation and transfer in contract testing laboratories.
  • Review and approve technical reports and lead presentations in internal and external technical review meetings.
  • Author and review regulatory submissions and provide strategic guidance to CMC teams on bioassay-related topics.
  • Provide technical troubleshoot to potency and residual methods during routine release and stability testing and investigate quality events in a team as a subject matter expert.
  • Manage project timelines, perform risk assessment, and present project updates to senior leaders.Knowledge, Experience and Skills:
    • Strong knowledge of GMPs and regulatory submissions experience required.
    • Experience working under GMP conditions for pivotal/commercial potency assay validation and transfer preferred.
    • A thorough understanding of commercial biologics quality control testing for lot release stabilty, and regulatory submission support required.
    • Strong communication and interpersonal skills required.
    • Have a strong organizational and planning skills and ability to work on multiple projects and manage tight project timelines as needed.
    • Ability to work in a complex, dynamic, global environment, thinking strategically and balancing both long and short-term priorities
    • Ability to successfully influence across levels and across functions.Basic Qualifications:
      • PhD with 5+ years of experience developing, validating, and transferring potency and residual methods in the biopharmaceutical industry.
      • Candidates should be self-motivated and organized, familiar with the relevant literature, and enjoy scientific investigation and thinking, proactively identify issues and develop solutions in a collaborative multidisciplinary environment.
      • Must have a thorough understanding on biologics production in a GMP environment, GMP compliance, novel route generation and implementation.
      • Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills.
      • Demonstrates collaborative communication and problem-solving spirit. The salary range for this position is: $168,980.00 - $218,680.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
        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 - careers@gilead.com - for assistance.
        - 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. About Us Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all Canada, Australia, Singapore, and Hong Kong employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. The health of our employees, contractors, their loved ones, our partners and the communities and people we serve is a top priority. Vaccination is the most effective way currently available to deliver on that priority.The purpose of the vaccination requirement is to minimize the spread of COVID-19 in the workplace and support the health and safety of our communities. A person is considered fully vaccinated two weeks after the second dose of a two-dose vaccine or two weeks after 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 an accommodation.

Keywords: Gilead Sciences, Inc., Oceanside , Sr. Research Scientist II, Other , Oceanside, California