Project Manager - Labs

Thermo Fisher Scientific • New Brunswick, NJ

1d • Onsite

About The Position

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.

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.
• 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.

Nice To Haves

• Project management experience preferred.

Responsibilities

• Manages project and program timelines, prioritizing LIMS data review and approval based on business needs, production dates, and filing requirements.
• 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.

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