Group Leader, Process R&D
Apotex
Brantford, AB
11d ago

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world.

We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion.

  • Our fully integrated operation is comprised of four lines of business : Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API);
  • and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year.

    We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

    Job Summary

    Is the PRD group leader for assigned New Product Development projects, to establish safe, cost competitive and robust processes suitable for transfer to Production.

    Provides leadership and supervision to ensure the effective planning and execution of all project experimentation and the evaluation of the corresponding results.

    Collaborates with group leaders and managers in other departments to ensure project timelines are adhered to.

    Job Responsibilities

  • Responsible for the supervision and mentoring of several PRD project teams, based on the phase of development, to efficiently undertake work supporting the following activities meeting the agreed upon timelines :
  • Identification and prioritization of potential routes of synthesis to any new development project target and then experimentally evaluate the highest priority routes, ultimately leading to proposing the commercial route for subsequent development.
  • Support the preparation of any patent application.

  • Solid form screening and the subsequent evaluation of the suitability and stability of any novel solid forms identified to support the solid form nomination for subsequent development.
  • As required, support the preparation of any patent application.

  • Select the optimum reaction, work-up and isolation conditions that maximize yield and purity of the resulting product.
  • Identification of impurities in starting materials, intermediates and final product and establish methods to minimize their formation and methods to assist with their purge.
  • Prepare samples and / or standards of any significant impurities to support analytical method development and validation.
  • Conduct robustness studies, including utilizing Design of Experiments methodology ahead of process transfer to Production.
  • Oversee the fate and impurity purging studies that will be used to support specification setting activities and to provide information used in the Process Development Report.
  • Technology transfer activities, working with the Technology Transfer team and Technology Transfer Coordinator to ensure that high quality Technology Transfer Communications are provided to the Technology Operations Group in a timely manner to support preparations for process implementation.
  • Collaborate with the Senior Chemist, Technical Information and Regulatory Affairs to support the preparations of the necessary process documentation, including the Process Development Report to support the DMF submission.
  • Ensure that all project information (patents, reports, schemes, flow diagrams, etc.) are filed appropriately.
  • Supervises assigned direct reports, and conduct all necessary performance management activities including their goal setting, regular review meetings, mid-
  • year and annual performance evaluations. Train and mentor new team members in process development strategies, regulatory guidelines and assist with problem solving.

  • Lead / chair cross functional project meetings, for example, Technology Transfer meetings, Research and Development project meetings.
  • Provide regular updates to management on the status of ongoing process development activities including any problems that might delay project milestones.
  • Works as a member of a team to achieve all outcomes.
  • Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion; Demonstrates strong and visible support of our values.
  • Performs all work in accordance with all SOPs, cGMP, established regulatory and health and safety requirements.
  • Supports the identification and implementation of efficient business processes related to process development and recommends the elimination of any non-value added activities.
  • Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion; and
  • All other duties as assigned.
  • Job Requirements

  • Education PhD or M.Sc. degree in Chemistry from a recognized academic institution
  • Knowledge, Skills and Abilities Proven track record in conducting and supervising scientific research, with highly developed problem solving and decision-
  • making skills. Excellent communication skills, both verbal and written. Proficiency in computer applications and programs such as SciFinder, Word, Excel, Power point and Project Management related software.

    Highly experienced writing and / or reviewing technical / scientific reports, etc. Good understanding of the regulatory guidelines for APIs (e.

    g. ICH, FDA / EMA, etc.). The ability to work as a member of a team and supervise. Effective interpersonal skills. Fosters excellent relationships with other departments to ensure a co-

    operative, mutually respective environment resulting in rapid resolution of problems and achievement of goals. Results oriented team player.

    The willingness to upgrade knowledge / education on an on-going basis.

  • Experience PhD degree minimum four years of relevant experience in pharmaceutical or fine chemicals industry M.Sc. degree minimum eight years of relevant experience in pharmaceutical or fine chemicals industry
  • At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

    Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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