FSP Associate Research Scientist: QC Strategy & Analytical Sciences

Thermo Fisher Scientific • New Brunswick, NJ

2d • Onsite

About The Position

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. 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.

Requirements

• Bachelor's degree in relevant life sciences program field
• 6-8 years of relevant experience within the pharmaceutical industry and with hands on experience in analytical chemistry with a focus on CMC development and/or commercial of novel drug candidates.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Senior