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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 improving health outcomes globally. For over three decades, we have addressed critical 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 to all. Our mission is driven by collaboration, determination, and a steadfast commitment to making a meaningful impact in the lives of patients.

Every individual at Gilead plays a vital role in the advancement of groundbreaking scientific innovations. Our workforce is our most valuable asset, and we seek passionate and driven individuals ready to contribute to our ambitious goals.

We believe that effective leadership is essential for employee success. As a leader, you will be instrumental in fostering a culture of inclusion, development, and empowerment, enabling every team member to achieve their potential. Together, we can create possibilities.

Position Summary: Senior Research Scientist I, Bioanalytical Chemistry

POSITION SUMMARY:

In this role, you will independently develop and implement bioanalytical strategies for method development, validation, and analysis of clinical study samples. These studies will encompass a range of phases from initial human trials to post-marketing activities, primarily conducted through contract research organizations (CROs). You will ensure compliance with GLP/GCP regulations to support Gilead's clinical initiatives. Collaborating with various stakeholders, you will oversee multiple facets of bioanalytical program activities, including:

  • Collaborating on functional area activities during program execution.
  • Contributing to bioanalytical design and clinical study protocols.
  • Leading bioanalytical method development and validation efforts.
  • Coordinating with internal teams and CROs for sample analysis.
  • Providing bioanalytical insights for clinical study reporting and regulatory submissions.

You will take on a leadership role, guiding both internal and external partners in bioanalytical design and execution, while also delivering innovative scientific ideas that propel our progress.

KEY RESPONSIBILITIES:

  • Contribute to product development strategies and clinical development plans for assigned projects.
  • Lead and manage bioanalytical activities of moderate complexity, serving as a key member of the cross-functional study team.
  • Provide bioanalytical input into clinical study protocols.
  • Collaborate with cross-functional partners and CROs to implement and oversee bioanalytical activities.
  • Ensure scientific oversight of bioanalytical method development, validation, and reporting at CROs.
  • Contribute to study documentation, data management plans, and scientific presentations.
  • Manage timelines and resources for timely execution of bioanalytical activities.
  • Present project updates and key milestones to stakeholders.
  • Anticipate and resolve potential issues in clinical studies through collaboration and innovative thinking.
  • Develop bioanalytical inputs for regulatory documentation for submissions.
  • Participate in the development and implementation of bioanalytical SOPs.
  • Provide leadership and matrix management for supported projects.
  • Adhere to regulatory standards, scientific principles, and company SOPs throughout study conduct.

QUALIFICATIONS:

We value diverse backgrounds and experiences. The following qualifications are essential for this role:

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

ADDITIONAL SKILLS:

  • Quick learner with adaptability to fast-paced environments.
  • Strong analytical skills demonstrated through past experiences.
  • Knowledge of FDA and EMA regulations, ICH guidelines, and clinical procedures.
  • Understanding of drug discovery and development processes.
  • Technical proficiency in bioanalytical workflows and laboratory operations.
  • In-depth knowledge of analytical instrument platforms, particularly LC-MS/MS.
  • Excellent communication and organizational skills.
  • Willingness to travel for site visits and audits as necessary.

The compensation for this position is competitive and reflects the experience and qualifications of the candidate. Additional benefits include medical, dental, vision, and life insurance plans.