The Principal Scientist role in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible for developing phase-appropriate methods to support clinical progression of small molecule drug candidates, supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in analytical method development and characterizati... more details
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Job Description
Principal Scientist I, Small Molecule Analytical Development, Analytical Development and Operations
The Principal Scientist role in the Analytical Development and Operations (ADO) organization reports to the Senior Director of Analytical Development (AD). AD is primarily responsible for developing phase-appropriate methods to support clinical progression of small molecule drug candidates, supporting process chemistry and formulation development, and generating data for regulatory submissions. The Principal Scientist will be a technical leader in analytical method development and characterization and a manager of multiple technical groups within AD.
Job Responsibilities:
Leads and develops analytical technical strategies, methods, and technologies to ensure the successful progression of small molecule assets from nomination through marketing application and commercial launch.
Directly manages multiple technical development teams and resources. Responsible for talent strategy, including leadership and development for scientific staff, to develop future senior talent and leaders.
Provides technical scientific expertise to CMC analytical project strategy groups and decision-making processes. Makes difficult scientific decisions to meet changing business needs. Fosters collaborations within AD group and with other functions within and outside the PDM organization.
Champions scientific innovation and technology to enable analytical method development while seeking opportunities to expand and develop capabilities to support project and departmental goals.
Contributes to developing scientific and technical strategies for the department. Advocates for new tools and technologies to advance process development and build departmental capabilities in support of project and departmental goals. Helps to develop policies and procedures related to departmental operations.
Applies global scientific guidelines to develop strategy to ensure continued clinical and marketing application approval successes.
Develops and drives phase-appropriate analytical development and validation strategies.
Collaborates closely with Analytical Project Strategy team. Forms 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. Drives rigor and consistency in analytical method development and control strategy identification.
Responsible for compliance with applicable corporate policies and procedures.
Knowledge and Skills:
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 through hands-on experience in design, execution and data analysis of laboratory techniques, including modern chromatography operating systems and through leading analytical development projects
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 are an asset
The salary range for this position is: $221,170.00 - $286,220.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
