Labs FSP - Associate Research Scientist - Project Management

Job Description

Title: Labs FSP - Associate Research Scientist - Project Management

Location: New Brunswick, NJ

*This is a Monday-Friday position on first shift, hybrid 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.

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.

A Day in the Life:

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, Strategic Sourcing & 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.

Responsibilities include:

• 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.

Keys to Success

Education:

• Bachelor’s degree in Biology, Biotechnology, Chemistry or related field

Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years).
• 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

Knowledge, Skills and Abilities:

• At least one year of experience in a GLP lab is required.
• Validated knowledge of stability and release testing.
• Experience in analytical chemistry
• Large molecule experience
• Must have hands on, technical, lab skills
• Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA
• Excellent communication skills
• Experience in handling CRO/CTOs, primarily in the area of analytical support
• 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, organizational change, team member alignment, and communication planning and results delivery.
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote, SharePoint) and business systems such as SAP/Ariba.

Working Environment:

Below is listed the working environment 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
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with
• proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to prioritize multiple projects or activities.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.