VP, Technical Operations

3 weeks ago

Edmonton, Canada BioTalent Canada Full time

Applied Pharmaceutical Innovation (API) brings life-saving research to the real world by helping life science innovators bridge the gap between academic research and commercial product development. We are driven, compassionate, and laser-focused on making a dramatic positive impact with everything we undertake.

When you join API, you are part of a rapidly growing team that is creating collaborative opportunities to commercialize Canadian life sciences discoveries, increasing the amount of commercial research and development in the country, and supporting Alberta as a key pillar in Canada’s life sciences sector.

Reporting to the CEO, the VP, of Technical Operations will serve as an integral member of API leadership by advancing its drug development pipeline for multiple indications and providing strategic guidance and leadership across the development spectrum. The core duties of the VP, Technical Operations are delineated below.

We are seeking an experienced VP, Technical Operations to manage and direct personnel and Good Manufacturing Practices (GMP) activities of Production, Quality, and Engineering in both active pharmaceutical ingredients as well as sterile manufacture with an emphasis on sterile injectable products.

This encompasses compliance in facilities, equipment, personnel, production and lab operations having an impact on the identity, strength, quality and purity of product supplied by the company.

Key Responsibilities, include but are not limited to:

Directing Production Operations

  • This will include managing the day-to-day operations over a number of facilities in the Edmonton Research Park (ERP):
    • Biotechnology Business Development Centre (BBDC) facility In the Research Park in Edmonton, is a multi-tenanted facility which includes a number of API units, some of which are in the process of being implemented.
    • API units at the BBDC include:
      • Drug Establishment License (DEL)
      • An active pharmaceutical ingredient GMP manufacturing unit
      • GMP Laboratories
      • Additional new projects under evaluation
  • Critical Medicines Production Centre (CMPC), a new 57,100 sq. ft. sterile products fill/finish facility in the process of being established in the ERP.
    • Qualification of the CMPC facility
    • Qualification of Equipment installed at the CMPC facility
    • Manufacture and Validation of Products at the CMPC facility

Directing Quality Operations

  • This will include:
  • Laboratories – Design, installation and qualification of GMP laboratories in the BBDC
  • Laboratories – Design, installation and qualification of GMP laboratories in the CMPC including microbiological testing
  • Quality Management System (QMS) – Implementation and validation of an electronic QMS to meet the companies future needs
  • Directing Engineering Operations
    • This includes all related activities:
      • Equipment – Installation Qualification (IQ), Operational Qualification (OQ), Process Qualification (PQ)
      • Applicable qualifications, including Computer Validation (CV)
      • Qualification of the Facility
  • Personnel Resources and Management
    • Accomplish human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, as per company policy.
    • Performance planning, monitoring, appraising, and reviewing job contributions.
    • Enforcing policies and procedures.
    • Responsible for performance management of direct reports.
  • Safety of Personnel
    • Ensure compliance with workplace policies and procedures for risk identification, risk assessment and risk control – Hazard Analysis and Critical Control Points (HACCP).
    • Operations to identify and report on health and safety risks, accidents, incidents, injuries and property damage at the workplace.
    • Operations to participate in established committees/teams relating to Environment Health and Safety (EHS).
  • Budgets and CAPEX
    • Maintain departmental expenses within an agreed budget.
    • Review monthly operating costs and output of each department.
    • Ensure CAPEX is within the approved budget and on time.

Education

  • Recognized university degree, preferably a Doctorate, in Chemistry and/or pharma related.

Experience:

  • Full understanding of GMP regulatory standards applicable to Canada, and a working knowledge of external regulations and requirements, such as US 21 CFR part 211 and EU GMP guide Part I.
  • Has served as a Head of Quality at Executive Directorate level, preferably with an internationally recognized company or companies.
  • Has acted in the capacity of a Quality Assurance Manager or higher for at least 15+ years.
  • 8+ years having senior management responsibility for the quality of sterile manufacture products, which will include injectables.
  • Has had senior management for large teams of employees.
  • Recognized for expertise in GMP audits, 3rd party management, and analytical tasks, ensuring excellence in batch release processes. This to include 10+ years experience in hosting recognized regulatory inspections.
  • Experience with setting up standard QC-GMP and microbiological testing laboratories.
  • 8+ years as a Quality or Production Head in the manufacture of Active Pharmaceutical Ingredients
  • Has implemented an electronic Quality Management System (QMS) and ERP systems.
  • Experience, minimum 10+ years producing products for clients.
  • Ability to lead and participate in cross-functional project teams.
  • Knowledge of oral product manufacture.
  • Subject matter expert for regulatory agencies, such as US FDA
  • Successfully performed Lean Six Sigma projects.
  • Expertise in the production of peptides, proteins and DNA.
  • Resourceful and results-driven leader.
  • Visionary in operational management.
  • Excellent in coaching, motivating and training employees.
  • Change agent and ability to adapt to changing circumstances.

Working Conditions:

  • Required travel between Edmonton API sites.

Additional Required Documents to Support Application

  • Applications submitted without a resume AND cover letter will not be reviewed.
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