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Associate Scientist - Method Validation Group

Employer
Gilead Sciences
Location
Belmont, CA
Closing date
May 28, 2022

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Sector
Science
Organization Type
Corporate
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Essential Duties and Job Functions:
  • Write and execute study plans and validation protocols.
  • Independently plans and executes that support research, development and GMP method validation activities.
  • Execute laboratory techniques such as water content, dissolution, disintegration, LC, GC, DSC, particle size, XRPD, and UV-Vis spectroscopy
  • Conduct test analysis of drug substance and drug product samples based on written procedures.
  • Review data to ensure compliance according to test methods, specifications, and protocols.
  • Participate in user requirements, assessment and validation of 21 CFR Part 11 software and/or customized software plus authoring SOPs, User Manuals and Training Documentation.
  • Apply knowledge of current Good Manufacturing Practices (cGMPs) concepts.
  • Author and revise test methods, technical reports, SOPs and relevant documents.
  • Participate in meetings, present and interpret data.
  • Work with Analytical Core Team and GMP Testing Group to lead all method feasibility, validation and release testing activities
  • Work with Regulatory Affairs & Quality Assurance to ensure that all applicable FDA regulations are followed.

Knowledge and Skills:
  • Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, GC, Dissolution, KF titration, Particle Size Distribution, etc.
  • Excellent technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical environments.
  • Strong working knowledge of cGMP and quality control (QC).
  • Knowledge in Lab information System and Part 11 software (e.g. Empower, Electronic Lab Notebook, SDMS and LIMS) to ensure data integrity rules are followed and documentation are in compliance.
  • Knowledge in Compliance System (e.g. Trackwise and GVault)
  • Demonstrates the ability to clearly and concisely present analysis results to different stakeholders.
  • Biologics experience is a plus
  • Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience.
  • Excellent verbal and written communication skills.

Education and Experience:
  • BS or BA degree in Chemistry, Biology or relevant science majors with 6+ years or M.S. degree with 4+ years of relevant experience in biotech/pharmaceutical experience
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