Labs FSP - Assoc Research Scientist - Project Mgmt - Biologics

at  Thermo Fisher Scientific

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.

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

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