Research Scientist, Analytical Operations
Job Responsibilities:
- Serve as SME, manage and provide technical and scientific leadership to a highly technical analytical method development team, including but not limit to:
- Physical and chemical characterization of drug substances, drug substance starting materials and intermediates, and drug products using techniques including HPLC, UPLC, GC, dissolution, particle characterization, X‐ray diffraction, thermal analysis, microscopy, and spectroscopy, to support process development, control strategy, or to achieve specific analytical goals
- Keeping abreast of new technologies and collaborating with internal and external organizations
- Providing technical and regulatory support to drug substance and drug product development, including impurity control strategies and process route development
- Employ data-driven approach to devise strategies
- Generating, reviewing, and approving necessary reports to provide scientifically sound and data-based support of product development, knowledge management, and data traceability. Serve on analytical teams supporting clinical development of drug candidates for solid dosage forms and/or parenteral products
- Partner with Process Chemistry, Formulations & Process Development, Quality Assurance, Regulatory, and other groups within Analytical Operations to support drug development, method, protocol or report preparation, and regulatory filings.
- Participate in departmental activities and improvements. Leadership in this area is also encouraged
- Lead and provide guidance in method validation and transfer to other Gilead sites and CTLs/CMOs
- Provide the highest quality analytical support, meet ambitious timelines and comply to SOPs, protocols, cGMPs and safety regulations
- Think independently while working in a team environment
Essential Education, Experience & Skills:
- Ph.D. in Chemistry (or another related science) or MS with 6+ years of pharmaceutical industry experience
- Excellent written and verbal communication skills required
- Strong desire to work in a collaborative and multi-disciplinary environment, learning new skills, and proactively solving problems
- Familiar with relevant regulatory guidance (e.g., USP, ICH, CFR) and apply in daily work and strategy
- Must be a critical and creative thinker in order to identify risks and gaps, and propose solutions or risk mitigation plans
- Be detail-oriented while understanding the CMC overall business needs
- Structural characterization expertise: LC-MS, GC-MS, NMR, some organic chemistry background preferred