Director, Small Molecule Analytical Development, Analytical Development and Operations

3 weeks ago

Foster City, United States Gilead Sciences, Inc. Full time
Director, Small Molecule Analytical Development, Analytical Development and Operations (ADO)

United States - California - Foster City Process/Product Development & Operations Regular

Job Description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.


Job Description

The Director role in the Analytical Development organization reports to the Senior Director of Analytical Development and is a leader in analytical method development. The role is satisfied by an experienced leader and scientist 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. The incumbent is a recognized industry leader who drives excellence in technical sciences, with a recognized reputation as an innovative chemist who focuses on staying ahead of technical changes and expectations in small molecule CMC development. This candidate is adept at identifying strategies and tactics for method and knowledge development to support product and dossier approval.

The successful candidate will be a proven people leader with a demonstrated leadership track record. Likewise, the candidate will be an expert at cross-functional collaboration, having shown experience in leading cross-functional teams, influencing peers and senior management and leading both with and without authority. This candidate fosters an innovative environment while focusing on achieving technical, regulatory and enterprise goals. This candidate creates an environment to attract, develop, retain, and promote excellent diverse scientific talent, communicates clearly and concisely to build effective relationships with peers and partners.

The candidate influences and provides input on the innovation and technical strategy of the Analytical Development and Operations function and represents and advocates for the team within the ADO ELT. The candidate is expected to provide and adhere to project plans, timelines and budgets. Management and maintenance of head count assignments by project, capacity and escalation of project risk is a mandatory characteristic of the successful candidate.

Focus Areas:

  1. 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.
  2. 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.
  3. 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.
  4. Champions scientific innovation and technology to enable analytical method development while seeking opportunities to expand and develop capabilities to support project and departmental goals.
  5. 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.
  6. Applies global scientific guidelines to develop strategy to ensure continued clinical and marketing application approval successes.
  7. Develops and drives phase-appropriate analytical development and validation strategies.
  8. 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.
  9. Responsible for compliance with applicable corporate policies and procedures.

Qualifications:

  1. 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.
  2. Leadership experience leading large and highly technical organizations.
  3. 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.
  4. Demonstrated ability in identifying and crafting technical and innovations strategies. Stays ahead of shifting trends in the industry.
  5. Demonstrated ability to attract and develop strong talent, grow the capabilities of an organization and develop people into future leaders.
  6. Proven capability to solve critical quality, regulatory and scientific problems.
  7. Strong understanding of cGMP and global regulatory requirements.
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