Project Controls Specialist-Biololgy

Position Purpose:

We are seeking a Project Controls Specialist to drive the execution of our next-generation In Vitro Diagnostic (IVD) device development projects and general biology R&D portfolio. In this role, you will be the analytical backbone of our project management office, maintaining total visibility over project health by tracking, analyzing, and optimizing project financials, schedules, and risk registers. The ideal candidate bridges the gap between data-driven project controls and hands-on biotechnology. We are looking for an analytical professional who understands the financial and scheduling constraints of a highly regulated environment, possesses a background in biology, and is enthusiastic about stepping into the laboratory when necessary to support the team.

Essential Duties and Responsibilities:

• Financial & Cost Management: Establish project cost baselines, track actual spending against budgets, perform variance analysis, and deliver precise financial forecasting.
• Schedule Management: Build, update, and maintain detailed, resource-loaded project schedules tracking hardware, software, clinical, and regulatory milestones.
• Risk & Change Control: Proactively identify, quantify, and track project risks. Manage the change control workflow, ensuring budget or timeline adjustments are meticulously documented.
• Laboratory & Project Support: Leverage your technical background to understand project dependencies. Perform limited, intermittent laboratory work to assist with data collection, material tracking, or testing setup as project milestones demand.
• Reporting: Generate clear, actionable performance dashboards and status reports for cross-functional stakeholders and leadership.

Required Knowledge, Skills & Abilities:

• Project Controls Experience: Minimum of 3–5 years of dedicated experience managing project costs, schedules, and risk management systems.
• Technical Software Skills: Proficiency with advanced scheduling tools (e.g., MS Project, Primavera P6) and robust financial/Excel modeling capabilities.
  Preferred candidates may also have experience in:
• IVD & Regulatory Experience: Direct experience navigating project lifecycles for In Vitro Diagnostics (IVD) or medical devices.
• Quality Management Systems: Proven familiarity working under an ISO 13485 Quality Management System (QMS) or FDA 21 CFR Part 820 environment.
• Biology & Lab Background: A foundational knowledge of biology with previous hands-on laboratory experience.
• Adaptability: A strong willingness and capability to conduct limited, hands-on laboratory tasks when required to keep project timelines moving forward.

Education/Experience:

•   Bachelor’s degree in Business, Biology, or a relevant technical field

Certificates and Licenses:

• Preferred candidates may have a Project Management Professional (PMP) certification or comparable accounting or management credentials. 

Clearance:

•   This position requires that the candidate be willing and able to complete a successful background screening for a security clearance. Candidates with an active security clearance will receive preference.

Supervisory Responsibilities:

None.

Working Conditions/ Equipment:

• This is a full-time, fully on-site position. This position primarily operates during standard business hours, with occasional needs for extended workdays or weekend work to meet project timelines. A minor portion of this role (less than 25%) may involve hands-on laboratory work. You should be comfortable spending extended periods standing while conducting experiments and sitting while working at a computer. The role may also require occasional domestic travel for conferences, trade shows, or research-related meetings. The ability to lift and carry light loads (under 25 lbs) without assistance is necessary.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.