Biotech Project Controls Specialist

Signature Science, LLC; Austin (TX); On-site; USD 85,000 - 110,000; Full time

Job summary

Signature Science, LLC in Austin, TX, seeks a Project Controls Specialist to drive the execution of next-generation IVD device development projects and the biology R&D portfolio. You will be the analytical backbone of the PMO, tracking budgets, schedules, and risks while supporting lab activities as milestones demand.

Applicants should have 3–5 years of project controls experience, proficiency with MS Project or Primavera P6, strong Excel modeling, and familiarity with ISO 13485 or FDA 21 CFR

Qualifications

• 3–5 years of project controls experience
• Proficiency with MS Project or Primavera P6 and strong Excel modeling
• Experience navigating IVD/medical device project lifecycles
• Familiarity with ISO 13485 QMS or FDA 21 CFR Part 820 environments
• Foundational biology knowledge with hands-on lab exposure
• Willingness to perform limited lab tasks to meet timelines
• PMP certification is preferred

Responsibilities

• Establish project cost baselines and forecast budgets
• Build and maintain detailed resource-loaded project schedules
• Identify, quantify, and track project risks; manage change control workflows
• Support laboratory work for data collection and testing setup as milestones demand
• Generate dashboards and status reports for stakeholders and leadership

Skills

Project controls

MS Project

Primavera P6

Excel modeling

Budgeting/Forecasting

IVD/medical device experience

Regulatory knowledge (ISO13485/FDA)

Lab background

PMP certification

Education

Bachelor's degree in Business or Biology or relevant field

Job description

Signature Science, LLC in Austin, TX, seeks a Project Controls Specialist to drive the execution of next-generation IVD device development projects and the biology R&D portfolio. You will be the analytical backbone of the PMO, tracking budgets, schedules, and risks while supporting lab activities as milestones demand.

Applicants should have 3–5 years of project controls experience, proficiency with MS Project or Primavera P6, strong Excel modeling, and familiarity with ISO 13485 or FDA 21 CFR