Job Title: Strategic Operations Project Specialist
Location: Portsmouth, NH (On-site)
As a Strategic Operations Project Specialist, you will serve as a technical and project management resource supporting manufacturing readiness, process improvements, quality initiatives, and cross-functional operational projects. You will partner with Manufacturing, Quality, Engineering, Validation, MSAT, and Project Management teams to drive successful project execution and operational excellence. This role requires strong technical knowledge, project ownership, stakeholder management, and the ability to lead initiatives from planning through implementation in a cGMP manufacturing environment.
This role follows a Monday-Friday day shift schedule from 8:00 AM to 5:00 PM.
What you will get
An agile career and dynamic working culture
An inclusive and ethical workplace
Compensation programs that recognize performance
Medical, dental, and vision insurance
Opportunities to grow and develop your career
A collaborative and team-focused environment
The opportunity to support the delivery of life-changing therapies
What you will do
Lead cross-functional projects that support manufacturing readiness, process improvements, and operational excellence
Manage project scope, timelines, deliverables, risks, and stakeholder communications from initiation through completion
Provide technical support and subject matter expertise for manufacturing processes, equipment, and systems
Support technical transfers, campaign readiness activities, and departmental readiness initiatives
Lead change control activities and complete project-related tasks to support successful implementation
Develop, track, and report key performance indicators to measure project and operational success
Investigate operational issues and identify opportunities for continuous improvement
Support procurement, installation, and implementation of manufacturing equipment and systems
Collaborate with Manufacturing, Quality, Engineering, Validation, and MSAT teams to achieve business objectives
Support customer-facing activities and represent Strategic Operations on Joint Project Teams when required
Support team activities, meetings, and continuous improvement efforts
What we are looking for
High school diploma or equivalent required; Bachelor's degree in Engineering, Biotechnology, Life Sciences, Manufacturing, or a related field preferred
5+ years of experience in biotechnology, pharmaceutical manufacturing, process operations, engineering, quality, or a related industry
Experience leading or supporting projects in a regulated manufacturing environment
Knowledge of cGMP requirements and quality systems
Experience with change controls, CAPAs, investigations, risk assessments, or validation activities
Strong project management, planning, and organizational skills
Strong analytical and problem-solving abilities with a continuous improvement mindset
Excellent written and verbal communication skills
Ability to build relationships and work effectively across multiple departments and stakeholder groups
