Work Schedule

Environmental Conditions

Job Description

The Senior Project Manager - Labs leads and has direct oversight for a portfolio of projects for a specific client and is accountable for overall project/portfolio performance. Proactively identifies resources, budgets projects, prioritizes client's portfolio in line with site-wide portfolio of projects and is the primary operational interface between PPD and the client. Negotiates and makes real-time decisions with the client. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.

This position is part of the Sample and Data Management group. In this role, personnel are responsible for the review and approval of data within LIMS, issuing Certificate of Analysis (CoA) and Detailed Sample Reports (DSRs), communicating timelines internally and externally, and facilitating other documentation as needed for the entire Clinical Biologics network, as well as assisting in other GLP/GMP compliance activities as assigned.

What You'll Do:
•    Manages project and program timelines, prioritizing LIMS data review and approval based on business needs, production dates, and filing requirements.
•    This is a fast-paced, high-volume role that requires efficient decision-making and the ability to adjust quickly to changing priorities across the Clinical Biologics network.
•    Reviews and approves data within LIMS to ensure data packages are complete, accurate, and available to support timely Certificate of Analysis (CoA), Detailed Sample Report (DSR), and regulatory filing needs.
•    Communicates internally and externally with analytical leads, contract laboratories, ATLs, analysts, managers, and personnel at other BMS sites to ensure data review and approval activities are completed in a timely manner.
•    Works closely with contract laboratories and analytical leads to track deliverables, communicate delays or issues that arise, and drive appropriate follow-up to support project and program timelines.
•    Troubleshoots LIMS issues identified during data review and approval, coordinating with appropriate stakeholders to resolve discrepancies, system questions, or process barriers.
•    Responsible for the issuance of various document types listed above and acts as project manager to ensure program timelines are met.
•    Responsible for independently creating, revising, formatting, routing, distribution, maintenance, and storage of departmental documents consistent with GMPs as needed.
•    Responsible for training department personnel and colleagues on documentation practices and templates as needed.
•    Cross-training in facilitation of Justification of Specifications, PD LIMS Specification creations/revisions routinely and as needed based on volumes.

•    Authors and revises department SOP’s, as applicable.
•    Ensures quality while processing a high volume of methods and technical documents.
•    Provides back-up support to manager and team members in support of other documents as needed.
•    Provides expertise and troubleshooting for Microsoft Word and Excel, Adobe Acrobat Pro, and EDMS systems.

Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

•    Project management experience preferred.
•    Proficient in Use of Electronic Systems: Microsoft Office Suite, DCA (Document Control and Archiving), Documentum, RMS (Records Management System), Adobe Acrobat, PDLIMS, and Internet Research.
•    Understands scientific concepts in order to conduct thorough review of documentation and data.
•    Knowledge of cGMP requirements 
•    5-10 years of GMP Documentation experience or bachelor’s degree and/or technical degree.

Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards