University of Alberta and the Royal Alberta Museum has flagged the PhD in Conservation Biology: Ecology of Wood Bison in Northeast Alberta: University of Alberta and The Royal Alberta Museum job as unavailable. Let’s keep looking.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Executive Director – Head of Process Chemistry, Alberta Site

KEY RESPONSIBILITIES

The Executive Director – Head of Process Chemistry, Alberta Site reports to Gilead’s Global Head of Technical Development and is responsible for leading a team of 75 scientists to develop safe, robust, and cost-effective processes for the manufacture of clinical and commercial synthetic molecule Drug Substances. In addition, the Executive Director will be a key member of the Alberta Site Leadership team, supporting operations, quality and manufacturing process plans that ensure the reliable production and delivery of high-quality drug substance products. They will also lead, model, and create an environment of inclusion, develop talent, and empower teams to achieve their goals.

The successful candidate will contribute their technical expertise and functional knowledge with industry know-how across multiple sites and multiple teams, directs execution of scientific research and development strategies and plans that support and align with organizational and therapeutic area strategic direction and roadmap to enable corporate objectives and ambitions. 

JOB DESCRIPTION

  • Lead and drive line function to collaborate across multiple sites and CMC functions to support and progress the small molecule portfolio advancement. Ensure collaboration across relevant Technical Development and Pharmaceutical Development and Manufacturing (PDM) functions (i.e., Process Chemistry in Foster City, Analytical Development, Formulation Development).
  • Lead teams with accountability to investigate a wide variety of engineering and scientific principles and concepts to potential inventions, drug development through to commercialization, and leadership to conceive and develop critical, long-range solutions.
  • Manage their staff with accountability for performance and results including: the development and characterization of chemical processes with a focus on robustness, sustainability and COGS, technical transfer to manufacturing sites, oversight of cGMP manufacture, and representation on CMC teams.
  • Develop their staff to deepen their expertise in disruptive route scouting utilizing innovative synthetic approaches, subsequent process development and process characterization and PPQ support.
  • Provide day-to-day leadership for the process development of synthetic molecule drug substance and direction/support for the various groups within the department and ensure collaboration across sites and functions. 
  • Coordinate and provide leadership in project prioritization/planning with/to the technical operations, supply chain and manufacturing areas to ensure deliveries of drug substances in accordance with the corporate timelines.
  • Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing small molecule strategies.
  • Evaluate and implement new technologies to drive innovation in Process Development for small molecules drug substance manufacturing.
  • Develop scientific and operational strategies of the process development, technical operations and manufacturing functions.
  • Demonstrate a thorough understanding of the cGMP environment (internal and external cGMP manufacturing operations) and compliance requirements.
  • Recruit, select, mentor, and coach direct reports.
  • Manage spending and resources in line with approved departmental budgets and corporate directives.
  • Support the achievement of all site goals, and Gilead’s Goals and Objectives, as applicable.
  • Establish functional area objectives and policies.
  • Communicate organizational objectives to people managers and interpret company policies.
  • Coordinate process development, technical operations and manufacturing resources and schedules based on commercial and/or clinical requirements.
  • Direct members of cross-functional teams in the initiation and execution of process development and manufacturing activities, considering economic, regulatory and safety factors.
  • Support and actively participate in (or lead) CMC and PDM Sub-teams for commercial products and development projects as required.
  • Assist in resolving operational, logistical, and prioritization issues associated with process development and manufacturing.
  • Review Development reports, Validation Plans and Protocols, and Validation Reports, and direct validation activities for the projects on site. Review and approve regulatory submissions, as required.
  • Recommend cost reduction opportunities related to process designs, materials, labor or overhead.
  • Interface with other functional groups to ensure that projects are progressed as planed and that site objectives are achieved.

QUALIFICATIONS

  • A PhD in chemistry (or related science or engineering) with a minimum of 14 years of directly relevant professional experience – ideally, in an R&D environment and/or pharmaceutical intermediates and actives manufacturing site.
  • 10+ years’ experience managing a manufacturing environment; specific understanding of API manufacturing preferred.
  • Strong knowledge and demonstrated implementation of Compliance Management – cGMP, technical operations, and quality systems.
  • Application of sound and accurate judgment to make timely decisions.
  • Demonstrated success in leading complex groups to support operational goals and contribute to the development of global regulatory initiatives.
  • Demonstrated organizational leadership skills at both functional and enterprise levels.
  • Excellent strategic acumen, collaboration, and communication skills are required.

Gilead Core Values

  • Integrity (Doing What’s Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Read Full Description
Confirmed 11 hours ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles