Technology Transfer Project Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Division/Site Specific Information:

Our Mississauga facility covers all phases of drug product development from early-phase formulation development to clinical trial material to commercial supply in the same plant using scalable equipment for non-GMP and GMP work.

Discover Impactful Work:

The Technology Transfer Project Manager (TTPM) 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 to enhance 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.

Day in the Life:

New Business Development

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

Project Management

• Identify key stakeholders for client requests and lead discussions to provide solutions.
• Lead, track, follows up and monitor project activities to ensure alignment with expectations and agreed-upon timeline.
• Oversee planning, execution, and closure of all Engineering/Feasibility/Optimization phase activities.
• Chair regular meetings and correspondence between internal and client teams.

Process Optimization

• Maintain document/information repository.
• 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.

Risk Management

• Proactively identify, evaluate, and mitigate risks to project timeline or commercial production.
• Work closely with the Technical Operations to fully understand scope and requirements for projects triggered by events on existing commercial products.

PDS Relationship Management

• Work 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

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

GMP & Health & Safety:

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

Evaluation of the Technical Costs

• Support the Commercial Quotes Group with the evaluation of the technical costs of the new job orders, providing the material technical details, production schedule, processes, and supply costs, aligning with the interests of the company.

Keys to Success:

Education:

Bachelor’s degree in science, engineering, pharmacy, or business.

Project Management Professional (PMP) certification is an asset

Experience:

Minimum 5 years’ previous experience in Engineering, Production, 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.

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific

• Medical, Dental, & Vision benefits-effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

OTHER

• Relocation assistance is NOT provided

• Must be legally authorized to work in Canada without sponsorship

• Must be able to pass a comprehensive background check

Compensation

The estimated annualized pay range for this position in Ontario is $76,400.00–$114,575.00.