FSP Sr Scientist: QC Strategy & Analytical Sciences

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Summary:

This role will support the Quality Control Strategy & Analytical Science (QCSAS) functions with the planning, creation, and execution of commercial projects with Contract Testing Labs (CTL) under the sponsorship of QCSAS. The position will interface extensively with inter disciplinary scientific staff, Quality/Compliance, Global Procurement (GP) and other functional areas. This role provides an excellent opportunity to utilize both scientific and project management skills set to contribute to the advancement of our growing pipeline and exciting portfolio.

Key Responsbilities:

• Managing overall external project activities, including but not limited to drafting the Scope of Work (SOW) document, facilitating and/or leading project progress meetings with CTLs, follow ups, alliance management, issue resolution/escalations and complete project close out activities.
• Establish and implement the Single Point of Contact (SPOC) model with our strategic and other partner CTLs.
• Establishes and maintains relationships with CTLs, planning, forecasting, coordinates project work, lead initiatives, assisting with gathering pricing information, contracting, metrics tracking and smooth execution.
• Ensures that CTLs follow applicable processes, SOPs and Quality Agreements.
• Liaise between technical teams, compliance and CTLs.
• Reviews project needs, estimate resources, budget and facilitates need for external work. Make recommendations when appropriate to move external work to internally supported work streams or other analytical collaborators.
• Seek to influence and drive changes to bring efficiencies and streamline processes.
• Ensures compliance with and maintains required training in relevant and departmental SOPs, GMPs, safety, and other guidelines.

Education/Experience:

• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)

• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)

• OR PhD

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

• Experience in working/managing CTLs, primarily in analytical support is preferred.
• Thorough understanding of cGMP’s is strongly preferred.
• Very good understanding of the drug development process and associated regulatory framework is essential.
• Must be able to work with CTLs and influence multi-departmental initiatives, work independently and with minimal supervision.
• Must be an effective communicator (oral and written) with good follow up skills and working with multiple stakeholders.
• Excellent project management skills - facilitation, planning, managing, budgeting, and execution.
• Great collaborator and be able to work very well in a team with multiple stakeholders.
• Proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint, OneNote) are essential.

Environment:

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds

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