Job Description

Business Job Title: Technical Project Leader

Job Profile Title: R&D Project Manager 3

Direct Report To: Site Leader Pharmaceutics

Group/ Division: PSG DPD Europe

Career Band: 6

Career Track: Manager

Position Location: Milton Park

Number of Direct Reports: 0

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Position Summary:

This role will lead PPT technical/scientific project activities applying expertise and experience in the development of appropriate of formulations and technical solutions to meet client expectations. It will lead and/or participate in technical discussions with clients.

Engaging in the management of clients, formulations, processes and equipment design for clinical and scale up batches including tech transfer to other Patheon facilities.

It will lead the design and evaluation of formulations and manufacturing processes and support problem solving as necessary

Managing the resources in the function to achieve project and team objectives. Liaising with Project Management, PPT Team, Supply Chain, Analytical Development and other functional areas to meet project and team objectives. This role may be supported by local or global experts as necessary.

May initiate external publications.

Responsibilities:

Key Job Challenges:

• Handling multiple projects and priorities at the same time.
• Apply his/her scientific expertise to execute projects in a timely manner.
• Work with CTM Operations Manager to achieve project objectives.
• Manage project resources and timelines. Work with project management to manage project timelines.
• Be client and patient conscious, considering quality, safety and project needs at all times.
• Support or lead OE activities and contribute to the continuous improvement of the PDS business locally and globally as appropriate
• Effectively lead across functional or Organizational boundaries.

Example of Job Challenges:

• Develop fit for purpose Phase 1 formulations and processes from protocol to delivery of batches
• Develop ‘market like’ formulations for scale up to late phase
• Develop robust manufacturing processes that meet or exceed the expectations from clients and provide innovation as necessary.
• Manage projects with demanding timelines and defined resources.
• Example of best human resource practices: performance management, career development, training, mentoring, guidance, coaching, etc.

Functional Guidance:

• Technical or local issues: Functional Senior Leadership (Site/Global)
• Project or client relationship issues/risks – immediate escalation to PM and relevant leaders

Key Contacts:

Internal:

• PDS staff at all levels of the organization.

External:

• Clients representatives (Scientific and Executive)
• Third Party Vendors
• Consultants

Nature of typical contact:

• Position will be called upon to work across functions to successfully complete work activities. The degree of persuasion may involve circumstances where parties’ initial viewpoints are significantly different.
• Working as part of a multi-disciplinary team
• Escalation of issues or risks.

Duties:

Note: This list details the general expectation, however, it is recognized that responsibilities differ across sites depending on functional structure. This list can be amended to meet the functional need but the principles must be honoured.

Lead Client New Business and Project Activities: (75%)

• Lead the design, evaluation, and development of formulations and manufacturing processes for solid dosage forms for Phase 1, Phase 2 and transfer to late phase.
• Lead/participate in problem solving for formulations, equipment, and processes.
• Write and ensure timely execution of protocols and development reports for feasibility work and manufacturing batch records for clinical trial materials in accordance with current Good Manufacturing Practices and company standards.
• Participate in relevant meetings/teleconferences with clients.
• Develop realistic proposals and timelines.

Functional Activities (25%):

• Liaise with Project Management, Operations manager, Materials Management, Analytical Development and other functional areas to meet project and team objectives.
• Support strategic initiatives and solutions for PPT and or PDS. Suggest improvements to systems or processes and be involved in implementing them. Work closely with site management to optimize requirements of both client and site for portfolio of projects.
• Maintain expert knowledge of pharmaceutical processes, equipment, instrumentation, and procedures necessary to perform the tasks. Keep current with scientific literature and industry trends relating to process technologies and disseminate relevant information. Key technical leadership role in Centre of Excellence Initiative; look for opportunities for publication/external presentations.
• Other duties as required.

EH&S:

• Understand emergency procedures and comply with safe systems of work.
• Ensure compliance with environment, health and safety rules, signage and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.