Associate Research Scientist: Biologics

Thermo Fisher Scientific • New Brunswick, NJ

4d • 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. Summary: This role will support the Biologics Development and Manufacturing Sciences and Technologies area core functions with the planning, creation and execution of CMC development projects with external parties under the sponsorship of ASO. The position will require extensive interfacing with inter disciplinary scientific staff, Quality, Global Procurement, Finance, Legal and other functional areas. This role provides an excellent opportunity to utilize both a scientific and project management background to contribute to the advancement of our growing 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 a focus in the area of CMC development of Biologics compounds.
• Understanding the experience of the drug development process and associated regulatory framework is essential.
• Must be able to work across and influence multi-departmental initiatives, work independently and with minimal supervision.
• Working knowledge of project management skills such as facilitation, planning, financial analysis, budgeting, change management, stakeholder alignment, and communication planning and results delivery.
• Excellent communication skills
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba are essential.

Nice To Haves

• 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 managing CRO/CTOs, primarily in the area of analytical support is preferred.
• Thorough understanding of cGMP’s is strongly preferred.

Responsibilities

• Facilitates project progress meetings with CROs, perform issue resolution and escalations and complete project close out activities
• Reviews project needs, estimate funds, and facilitates SOWs
• Assists with the maintenance of the outsourced book-of-work database for select strategic partners.
• Ensures that CROs follow applicable SOPs and Quality Agreements.
• Ensures compliance with and maintains required training in relevant BMS and departmental GMP, GLP, SOP, safety, and other guidelines.
• Maintains joint BMS and CRO SharePoint sites

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: Mid Level