Executive Director – Head of Process Chemistry, Alberta Site

Gilead Sciences

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For Present Gilead Staff and Contractors:

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At Gilead we imagine each worker deserves a terrific chief. As a individuals chief now or sooner or later, we count on that you’ll mannequin and create an surroundings of inclusion, be deliberately targeted on the hiring, growth, development and retention of expertise, and empower groups to align and obtain objectives.

Job Description

Gilead Sciences, Inc. is a biopharmaceutical firm that has pursued and achieved breakthroughs in medication for greater than three many years, with the objective of making a more healthy world for all individuals. The corporate is dedicated to advancing modern medicines to forestall and deal with life-threatening ailments, together with HIV, viral hepatitis, and most cancers. Gilead operates in additional than 35 international locations worldwide, with headquarters in Foster Metropolis, California.

Government Director – Head of Course of Chemistry, Alberta Web site

KEY RESPONSIBILITIES

The Government Director – Head of Course of Chemistry, Alberta Web site reviews to Gilead’s World Head of Technical Growth and is chargeable for main a staff of 75 scientists to develop secure, sturdy, and cost-effective processes for the manufacture of medical and business artificial molecule Drug Substances. As well as, the Government Director will likely be a key member of the Alberta Web site Management staff, supporting operations, high quality and manufacturing course of plans that make sure the dependable manufacturing and supply of high-quality drug substance merchandise. They can even lead, mannequin, and create an surroundings of inclusion, develop expertise, and empower groups to attain their objectives.

The profitable candidate will contribute their technical experience and practical information with trade know-how throughout a number of websites and a number of groups, directs execution of scientific analysis and growth methods and plans that assist and align with organizational and therapeutic space strategic route and roadmap to allow company goals and ambitions. 

JOB DESCRIPTION

  • Lead and drive line operate to collaborate throughout a number of websites and CMC features to assist and progress the small molecule portfolio development. Guarantee collaboration throughout related Technical Growth and Pharmaceutical Growth and Manufacturing (PDM) features (i.e., Course of Chemistry in Foster Metropolis, Analytical Growth, Formulation Growth).
  • Lead groups with accountability to research all kinds of engineering and scientific rules and ideas to potential innovations, drug growth via to commercialization, and management to conceive and develop important, long-range options.
  • Handle their workers with accountability for efficiency and outcomes together with: the event and characterization of chemical processes with a give attention to robustness, sustainability and COGS, technical switch to manufacturing websites, oversight of cGMP manufacture, and illustration on CMC groups.
  • Develop their workers to deepen their experience in disruptive route scouting using modern artificial approaches, subsequent course of growth and course of characterization and PPQ assist.
  • Present day-to-day management for the method growth of artificial molecule drug substance and route/assist for the assorted teams inside the division and guarantee collaboration throughout websites and features. 
  • Coordinate and supply management in undertaking prioritization/planning with/to the technical operations, provide chain and manufacturing areas to make sure deliveries of drug substances in accordance with the company timelines.
  • Function a senior member of the Technical Growth Management Workforce chargeable for growing and establishing small molecule methods.
  • Consider and implement new applied sciences to drive innovation in Course of Growth for small molecules drug substance manufacturing.
  • Develop scientific and operational methods of the method growth, technical operations and manufacturing features.
  • Display an intensive understanding of the cGMP surroundings (inside and exterior cGMP manufacturing operations) and compliance necessities.
  • Recruit, choose, mentor, and coach direct reviews.
  • Handle spending and sources in keeping with accredited departmental budgets and company directives.
  • Help the achievement of all website objectives, and Gilead’s Objectives and Goals, as relevant.
  • Set up practical space goals and insurance policies.
  • Talk organizational goals to individuals managers and interpret firm insurance policies.
  • Coordinate course of growth, technical operations and manufacturing sources and schedules primarily based on business and/or medical necessities.
  • Direct members of cross-functional groups within the initiation and execution of course of growth and manufacturing actions, contemplating financial, regulatory and security elements.
  • Help and actively take part in (or lead) CMC and PDM Sub-teams for business merchandise and growth initiatives as required.
  • Help in resolving operational, logistical, and prioritization points related to course of growth and manufacturing.
  • Evaluation Growth reviews, Validation Plans and Protocols, and Validation Reviews, and direct validation actions for the initiatives on website. Evaluation and approve regulatory submissions, as required.
  • Suggest value discount alternatives associated to course of designs, supplies, labor or overhead.
  • Interface with different practical teams to make sure that initiatives are progressed as planed and that website goals are achieved.

QUALIFICATIONS

  • A PhD in chemistry (or associated science or engineering) with a minimal of 14 years of straight related skilled expertise – ideally, in an R&D surroundings and/or pharmaceutical intermediates and actives manufacturing website.
  • 10+ years’ expertise managing a producing surroundings; particular understanding of API manufacturing most well-liked.
  • Robust information and demonstrated implementation of Compliance Administration – cGMP, technical operations, and high quality methods.
  • Software of sound and correct judgment to make well timed selections.
  • Demonstrated success in main advanced teams to assist operational objectives and contribute to the event of world regulatory initiatives.
  • Demonstrated organizational management expertise at each practical and enterprise ranges.
  • Wonderful strategic acumen, collaboration, and communication expertise are required.

Gilead Core Values

  • Integrity (Doing What’s Proper)
  • Inclusion (Encouraging Variety)
  • Teamwork (Working Collectively)
  • Excellence (Being Your Greatest)
  • Accountability (Taking Private Duty)

As an equal alternative employer, Gilead Sciences Inc. is dedicated to a various workforce. As a way to guarantee affordable lodging for people protected by Part 503 of the Rehabilitation Act of 1973, the Vietnam Period Veterans’ Readjustment Act of 1974, and Title I of the Individuals with Disabilities Act of 1990, candidates who require lodging within the job utility course of might contact [email protected] for help.

For Present Gilead Staff and Contractors:

Please log onto your Inner Profession Web site to use for this job.

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