Job Description

Summary:
The Technology Transfer Project Manager is able to fully master technical skills with respect to client and business requirements and identifies solutions aligned with these requirements. Responsible for the effective and efficient management of client-related projects in order to increase client service and satisfaction in the overall best interest of Thermo Fisher. Actively involved in the technology transfer portion of the quotations and negotiations process for new products/projects (including validation for commercial production). Supports projects of a medium size, scope and complexity as it relates to Technical Excellence, Client Experience and Relationship Management and Growth of the business.
Essential Functions:
New Business Development

• Contributes the definition of new business opportunities while meeting with the existing/potential clients, together with Business Management, during technical meetings with the scope of obtaining new products or the revision of the progress status/completion of projects.

Technology Transfer

• Maintains continuous contact with the clients, focusing on the clients’ requirements and the interests of the company.
• Generates 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.

Project Management

• Leads, tracks, follows up and monitors project activities to ensure alignment with expectations and agreed-upon timeline.
• Oversee planning, execution and closure of all Engineering/Feasibility/Optimization phase activities.
• Chairs regular meetings and correspondence between internal and client teams.

Optimization of the Production Costs

• Maintains document/information repository.
• Contributes 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.

Risk Management

• Supports and advices Business Management with the definition of the technical risks related to the acquisition of the new job orders, through collecting necessary details required for the evaluation, and completing the evaluation, respecting the interests of the company.
• Works closely with the Process Engineer to fully understand scope and requirements for projects triggered by events on existing commercial products.

PDS Relationship Management

• Works closely with Pharmaceutical Development Services (PDS) formulator to follow and understand early stage product development for PDS-to-Commercial product transfers.

Internal Support and Client Relations

• Provides support as needed to Production during the Pre-Validation/ Validation/Stability phase, including review of process validation documents.
• Provides support as needed to all company functions throughout the course of the project
• Provides support as needed to Potential and existing clients until time of the production transfer from the client to Thermo Fisher.

GMP & Health & Safety:

• Ensures cGMP is applied in work area and follows cGMP in all areas of the business.
• Understands and apply as needed, emergency procedures and safe systems of work.

REQUIRED QUALIFICATIONS
Education:
Bachelor’s degree science, engineering, pharmacy or business.
Project Management Professional (PMP) certification is an asset
Experience:
Minimum 5 years’ previous experience in Engineering, Productions, Quality, or relevant contract
manufacturing environment.
Minimum 3 years project management and/or client service experience.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities:
Strong 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 acumen 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. Well
organized with strong attention to detail. Ability to work both in a team environment as well as independently as required. Demonstrated computer proficiency with Microsoft Office programs and database management skills. 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, etc.). 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 identify areas for improvement in the execution of procedures. Communicate risks to timelines of deliverables in a proactive manner. Consistently strives to improve skills and knowledge in related field.