Sr Technology Transfer Project Manager

Work Schedule

Environmental Conditions

Job Description

The Sr Technology Transfer Project Manager (Sr TTPM) is technically proficient with respect to client and business requirements and responsible for the dissemination and the successful completion of complex Tech Transfer projects. The responsibilities include optimizing production process where possible, evaluating technical costs and resource requirement of assigned projects, and determining procedures and processes on new assignments which may include the coordination of activities of other employees. The Sr TTPM is responsible for the effective and efficient management of client-related projects to maximize client service and satisfaction in the overall best interest of Thermo Fisher.  Actively leads the client negotiation process for (new) projects in the areas of technology transfer portion (including validation for commercial production).  Supports key network projects of a large 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

• Contribute and provide key inputs to the definition of new business opportunities while meeting with the existing/potential clients, together with the 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. 
• Assign and coordinate the tasks related to the introduction of new processes/projects within the site.
• 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.
• Identify, lead improvement initiatives to optimize product or process efficiency.

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 for the most complex cases.

Internal Support and Client Relations

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

GMP and 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.

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

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

Equivalency:

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

Knowledge, Skills, Abilities:

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 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. Excellent organizational skills with detail orientation Ability to -lead a team as well as working independently as required. Demonstrated computer proficiency with Microsoft Office programs and database management skills. Proficiency with the English Language.

Compensation