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Lead Bioanalytical Research Scientist

2 months ago

Foster City, California, United States Gilead Sciences Full time

Job Overview

At Gilead Sciences, we are dedicated to enhancing global health outcomes. For over three decades, we have addressed significant health challenges, including HIV, viral hepatitis, COVID-19, and cancer. Our commitment to developing innovative therapies is unwavering, and we strive to ensure that these advancements are accessible worldwide. Our mission demands collaboration, tenacity, and an unyielding passion to make a meaningful impact.

Each member of our team is vital to the advancement of groundbreaking scientific innovations. Our workforce is our most valuable asset as we pursue ambitious goals, and we seek individuals who are enthusiastic and driven to contribute positively.

We believe that effective leadership is essential for employee success. Leaders at Gilead are pivotal in shaping our culture and fostering an inclusive environment where every team member feels valued, nurtured, and empowered to achieve their goals. Join us in our mission to create impactful solutions together.

Position Summary: Senior Scientist, Bioanalytical Chemistry

ROLE DESCRIPTION:

In this role, you will take on increasing responsibilities in developing and executing bioanalytical strategies for method development, validation, and analysis of clinical study samples. These activities span from initial human trials to post-marketing assessments, often conducted through contract research organizations (CROs), while ensuring adherence to GLP/GCP regulations to support our clinical initiatives. You will collaborate with various stakeholders and manage multiple facets of bioanalytical program operations.

KEY RESPONSIBILITIES:

  • Contribute to product development strategies and clinical research plans for assigned projects.
  • Lead and oversee bioanalytical activities of moderate complexity, collaborating with cross-functional study teams.
  • Provide bioanalytical insights for clinical study protocols.
  • Collaborate with internal teams and CROs to implement and monitor bioanalytical activities, addressing any arising issues.
  • Ensure scientific oversight of bioanalytical method development, validation, and reporting at CROs, aligning with global regulatory standards.
  • Assist in the preparation of study documentation, data management plans, and scientific presentations.
  • Manage timelines and resources to ensure efficient execution of bioanalytical tasks.
  • Present project updates and significant milestones to stakeholders.
  • Anticipate and resolve potential challenges in clinical studies through innovative problem-solving.
  • Contribute to regulatory documentation for submissions.
  • Participate in the development and implementation of bioanalytical standard operating procedures (SOPs).
  • Provide leadership and guidance to project teams.
  • Comply with regulatory standards, scientific principles, and internal procedures throughout study conduct.

QUALIFICATIONS:

We recognize that diverse backgrounds contribute to our success. Below are the qualifications and skills we seek for this position:

  • PhD in chemistry, pharmaceutical sciences, or a related field with a minimum of 2 years of relevant experience in bioanalytical assay development.
  • MS in chemistry or related discipline with at least 8 years of relevant experience.
  • BA/BS in chemistry or related field with a minimum of 10 years of relevant experience.
  • Proficiency in techniques for collecting and analyzing biological samples.
  • Familiarity with global regulatory requirements for bioanalysis.
  • Extensive experience working in cross-functional teams in drug research or development.
  • Proven track record in bioanalytical method design, validation, and regulatory submissions.
  • Experience in scientific publication and presentation is advantageous.
  • Demonstrated success in scientific research within academic or industry settings.

ADDITIONAL SKILLS:

  • Ability to learn quickly and adapt to a dynamic environment.
  • Strong analytical skills demonstrated through prior experience.
  • Knowledge of FDA and EMA regulations, ICH guidelines, and clinical procedures.
  • Understanding of drug discovery and development processes.
  • Technical proficiency in bioanalytical workflows and instrumentation.
  • Strong communication and organizational skills.
  • Willingness to travel for site visits and audits as necessary.

The compensation for this role is competitive and commensurate with experience and qualifications. Additional benefits may include performance-based bonuses and comprehensive health insurance plans.