Strategic Operations Project Specialist

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Career development

Team environment

Life-changing therapies

Job summary

Lonza is seeking a Strategic Operations Project Specialist in Portsmouth, NH, to drive manufacturing readiness and process improvements in a cGMP setting. You will lead cross-functional projects, manage scope and timelines, and provide technical support across manufacturing processes and equipment.

The role emphasizes change control, risk assessment, and collaboration with Quality, Engineering, Validation, and MSAT teams to achieve business objectives.

Qualifications

• High school diploma or equivalent is not sufficient; a Bachelor's degree in Engineering, Biotechnology, Life Sciences, Manufacturing, or related field is preferred.
• 5+ years of experience in biotechnology, pharmaceutical manufacturing, process operations, engineering, quality, or 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.

Responsibilities

• 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

Skills

Project management

Stakeholder management

Cross-functional collaboration

cGMP knowledge

Analytical problem solving

Communication skills

Education

Bachelor's degree in Engineering or Life Sciences

Tools

MS Office Suite

PM software/tools

Job description

United States, Portsmouth (New Hampshire)

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

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.