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Manager Technology Transfer Projects

3 months ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Summary:

Manages the coordination of the activities of the Technology Transfer (TT) function on site and is responsible for the department results. Accountable for the performance of the team within TT and the management of the transfer projects of pharmaceutical products from clients to Thermo Fisher Scientific. The transfer takes place through feasibility analysis, evaluation of transfer and production costs, and coordination of transfer activities, fulfilling client requirements, cGMP standards, Thermo Fisher Scientific's interests and company quality standards.

Essential Functions:

Technical Support to Business

  • Provide technical support for more complex new business opportunities with existing/potential new clients.
  • Attend technical meetings to define the scope of obtaining new projects, together with the Business Managers and TT team members.
  • Research and support the definition of new business opportunities.
  • Meet with existing/potential clients, together with the Business Managers, in the occasion of technical meetings with the scope of obtaining new products or the revision of the progress status/completion of projects.
  • Evaluate the client production process in order to compare Thermo Fisher Scientific production systems (gap analysis).
  • Support the Business Managers by attending business reviews and client meetings.

Tech Transfer Projects Management

  • Ensure TT team is meeting client requirements related to scope.
  • Generate key documentation including the Technology Transfer Checklist, Gap Analysis that includes process design, Technology Transfer Master Plan/Scope, Technology Transfer Report, Project Timeline and Action Item lists.
  • Assign and coordinate Tech Transfer specific tasks; identify root cause of technical problems as well as project team management until resolution. Contacts clients with respect to their project requirements.
  • Attend Tech Transfer meetings with Site Management in order to share timing and milestones of projects.
  • Manage and coordinate all activities that take place within the Tech Transfer department.

Optimization of Production Processes

  • Contribute to the optimization of the production process, with continuous efforts to increase project savings on the technical side while maintaining compliance with cGMP and company procedures.
  • Identify and coordinate initiatives related to the Tech Transfer projects to minimize production costs, maintaining company quality standards.
  • Deliver agreed upon timelines towards 100% on time launch.

New Projects

  • Support the Business Management team with the evaluation of the technical costs of new job orders, provide the material technical details, production schedule, processes, supply costs to reflect Thermo Fisher Scientific interests.
  • Support the Business Management team to define technical risk related to the acquisition of new projects.

Team Management

  • Manage, coordinate and control workload for direct reports by defining objectives and evaluating performance.
  • Ensure the right level of team training and development as needed in order to guarantee a high level of performance and motivation.
  • Generate and complete development plans for TT team members.
  • Mentor and coach TT team members.
  • Promote a safe working environment, reports potential hazards, and ensures all direct reports follow the Environmental Health and Safety procedures.

REQUIRED QUALIFICATIONS

Education:

Bachelor's degree science, engineering, pharmacy, or business.

Master's degree science, engineering, pharmacy, or business is an asset.

Project Management Professional (PMP) certification is an asset

Experience:

Minimum 7 years' previous experience in Engineering, Productions, Quality, or relevant contract manufacturing environment.

Minimum 5 years' project management and/or clients service experience.

Minimum of 5 years' previous supervisory experience.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities:

Strong Leadership skills and ability to successfully lead a team of Project Managers. Advanced negotiation and communication skills (both oral and written). Strong Project Management skills including keeping client relationship on track and mend difficult relationships. Commercial business orientation and financial competency. Strong knowledge and understanding of manufacturing/operational processes. Excellent knowledge of Good Manufacturing Practices and Food and Drug Administration (FDA) compliance knowledge. Effective interpersonal skills, and the ability to collaborate with influence and motivate cross-functional team members. Ability to meet deadlines and prioritize multiple project deliverables. Excellent organizational skills with detail orientation. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English Language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work harmoniously with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, shared laboratory assets). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identifies areas for improvement in the execution of analytical procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in pharmaceutical development.