Director of Analytical Development

14 hours ago

Foster City, California, United States BioSpace, Inc. Full time
Job Description

The Director, Small Molecule Analytical Development, Analytical Development and Operations (ADO) role is a critical leadership position within our organization. As a seasoned expert in small molecule analytical development, you will be responsible for shaping the development strategy for analytical methods, implementing methodologies according to the analytical control strategy, and data collection for regulatory submissions to support small molecule candidate progression from discovery to marketing application approval.

Key Responsibilities:
  • Lead and develop analytical technical strategies, methods, and technologies to ensure the successful progression of small molecule assets from nomination through marketing application and commercial launch.
  • Directly manage multiple technical development teams and resources, responsible for talent strategy, including leadership and development for scientific staff, to develop future senior talent and leaders.
  • Provide technical scientific expertise to CMC analytical project strategy groups and decision-making processes, making difficult scientific decisions to meet changing business needs.
  • Champion scientific innovation and technology to enable analytical method development, seeking opportunities to expand and develop capabilities to support project and departmental goals.
  • Contribute to developing scientific and technical strategies for the department, advocating for new tools and technologies to advance process development and build departmental capabilities in support of project and departmental goals.
  • Apply global scientific guidelines to develop strategy to ensure continued clinical and marketing application approval successes.
  • Develop and drive phase-appropriate analytical development and validation strategies.
  • Collaborate closely with Analytical Project Strategy team, forming cross-functional alliances with Small Molecule Drug Substance Development, Small Molecule Drug Product Development, CMC Regulatory Affairs, Quality Control, and Manufacturing Operations by providing SMEs to these functions and project teams.
  • Responsible for compliance with applicable corporate policies and procedures.
Requirements:
  • PhD in Chemistry, Analytical Chemistry, Chemical Engineering, or closely related discipline with 8+ years of experience in the pharmaceutical and/or biotechnology industry; or MA/MS with 10+ years of experience; or BA/BS with 12+ years of similar training and experience.
  • Leadership experience leading large and highly technical organizations.
  • Expertise in small molecule analytical development and CMC development is a must. Broad understanding of both scientific and regulatory requirements in the areas of responsibility and overall pharmaceutical R&D, as well as manufacturing and quality.
  • Demonstrated ability in identifying and crafting technical and innovations strategies. Stays ahead of shifting trends in the industry.
  • Demonstrated ability to attract and develop strong talent, grow the capabilities of an organization, and develop people into future leaders.
  • Proven capability to solve critical quality, regulatory, and scientific problems.
  • Strong understanding of cGMP and global regulatory requirements.
What We Offer:

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We offer a competitive salary range of $221,170.00 - $286,220.00, discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package, including company-sponsored medical, dental, vision, and life insurance plans.

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.

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