Biopharma Technology Transfer Project Specialist

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The Technology Transfer Project Specialist will manage the introduction of new pharmaceutical products in commercial manufacturing. Technology Transfer Project Specialist operates under moderate supervision, with autonomy, and escalates mid to critical or strategic issues to management. This role requires previous experience in project management, client relationships, and technical expertise.

RESPONSIBILITIES

Technology Transfer:

• Maintain continuous contact with clients, focusing on their requirements while considering the company's interests.
• Understand and highlight project conflicts within the company and with clients, provide resolutions that satisfy both parties, or escalate risks and issues to management when necessary.
• Generate key documentation such as the Technology Transfer List, Gap Analysis, Technology Transfer Plan, Technology Transfer Report, Project Timeline, and Action Item lists, ensuring reports are issued according to project timelines.
• Ensure that client’s project requirements are accurately received and processed by internal functions.
• Manage, track and monitor identified project scope, timing, progress and risks.
• Manage Tech Transfer interdisciplinary groups, ensuring effective task assignment and coordination.
• Coordinate the start, progress tracking, and completion of projects by staying in regular communication with team members to address and solve issues.
• Coordinate changes and improvements strategy for assigned project, adherence to cGMP and company procedures.

Project Management:

• Manage multiple client projects, overseeing planning and execution at all stages
• Structure projects in alignment with client strategy, demonstrating an entrepreneurial approach, optimizing processes, identifying needs, defining resource requirements, tracking performance, and pinpointing improvement opportunities.
• Serve as the primary contact and communication link between the company and clients.
• Manage, track, and monitor project activities to ensure alignment with expectations and timelines.
• Oversee planning, execution, and closure of all engineering, feasibility, and optimization phase activities up to the completion of PPQ batches.
• Chair regular meetings and facilitate correspondence between internal teams and clients.
• Coordinate with Thermo Fisher Subject Matter Experts (SMEs) and leverage systems implemented at other sites.
• Assume a coordinator role on projects, supporting cross-functional teams and strategically planning timelines to ensure timely completion.
• Support the harmonization efforts for the Technology Transfer process across the sterile network and align with Global Technology Transfer Operations.

GMP:

• Ensure cGMP standards are applied in the work area and are followed in all relevant business functions.
• Possess knowledge of quality standards and collaborate with key stakeholders to deliver the best products.
• Understand and apply emergency procedures and safe work systems as needed.

KEY REQUIREMENTS/QUALIFICATIONS

Education:

• A Bachelor’s Degree or its equivalent in a scientific/pharmaceutical area (Pharmacy, Chemistry, Biotechnology etc.) or in engineering.

Technical Skills:

• Knowledge of pharmaceutical production and techniques.
• Advanced client service and project management experience.

Experience:

• Minimum 3 years of experience in Engineering, Production, Quality, or a relevant pharmaceutical environment.
• Pharmaceutical industry or Contract Manufacturing experience strongly preferred.
• Prior role with client interaction experience required.

Desirable:

• PMP certification is an asset, along with experience in client service or project management.