Technology Transfer Project Manager

at  Thermo Fisher Scientific

SUMMARY:

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 in order 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.

EDUCATION:

Bachelor’s or Advanced degree in science, engineering, pharmacy, or business.
Project Management Professional (PMP) certification is an asset

EXPERIENCE:

• Bachelors degree and 5+ years’ previous experience; or Advanced degree and 3+ years previous experience. Experience in Engineering, Productions, Quality, or relevant contract manufacturing environment.

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.

PHYSICAL REQUIREMENTS:

Light physical effort and fatigue. Walks, sits, or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

DISCLAIMER:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees

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.