Product Development Manager GMP Operations

Lonza; Tampa (FL); On-site; Confidential; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Learning & Development programs

Job summary

Lonza in Tampa, FL is seeking a Product Development Manager GMP Operations to lead site‑based PD GMP manufacturing and packaging for early‑phase clinical trial products. Responsibilities include designing GMP spaces, acting as SME, and guiding cross‑functional teams while ensuring regulatory readiness and high performance.

Ideal candidates hold an advanced science degree and 10+ years in GMP environments, with strong leadership and stakeholder management skills to drive strategic growth

Qualifications

• MS or PhD in science or related field
• 10+ years of experience in early‑phase GMP drug product manufacturing
• OSD experience in early‑phase GMP drug product manufacturing
• Strong understanding of cGMP regulations and quality systems
• Proven ability to lead technical teams and manage resources
• Experience designing or supporting GMP facilities and build‑outs

Responsibilities

• Lead and develop Product Development GMP manufacturing operations for early‑phase drug products
• Design and maintain PD GMP spaces, equipment selection, and engineering drawings approval
• Serve as SME for PD GMP activities, supporting projects and new technologies
• Provide leadership and development for a diverse technical team
• Ensure compliance with cGMPs, SOPs, safety standards, and regulatory inspections
• Coordinate with engineering, quality, manufacturing, and project teams for timely delivery

Skills

Leadership

Program management

cGMP knowledge

Regulatory inspections

Stakeholder management

Education

MS or PhD in science

Job description

Product Development Manager GMP Operations

Tampa, FL, USA

The actual location of this job is in Tampa, FL. Relocation assistance is available for eligible candidates and their families, if needed.

The Manager, Product Development GMP Operations is a site‑based leadership role supporting early‑phase clinical trial drug product manufacturing and packaging. This position offers the opportunity to design and lead GMP capabilities, guide multidisciplinary teams, and directly contribute to bringing innovative therapies into the clinic.

What you will get

• An agile career with opportunities for growth in a dynamic Product Development environment
• A collaborative, inclusive, and ethical workplace culture
• Compensation programs that recognize high performance and leadership impact
• Competitive medical, dental, and vision insurance coverage
• Access to Lonza’s learning, development, and leadership programs

What you will do:

• Lead and develop Product Development GMP manufacturing operations supporting early‑phase clinical trial drug products
• Design, oversee, and maintain PD GMP spaces, including equipment selection, engineering build‑outs, and approval of engineering drawings
• Serve as the technical and operational SME for PD GMP activities, supporting projects, new technologies, and strategic growth initiatives
• Provide leadership and administrative management for a diverse technical team, including performance reviews, coaching, training, and career development
• Ensure compliance with cGMPs, SOPs, safety standards, and regulatory requirements, maintaining inspection readiness at all times
• Act as a key internal and external stakeholder, participating in regulatory audits, client meetings, and on‑site visits
• Coordinate closely with engineering, quality, manufacturing, and project teams to ensure timely, compliant, and cost‑effective delivery of work

What we are looking for:

• M.S. or Ph.D. in science or concentrated studies that meets or exceeds minimum years of experience requirement
• 10+ years of experience early‑phase GMP drug product manufacturing within a pharmaceutical or life sciences environment
• OSD (Oral Solid Dosage) experience in early‑phase GMP drug product manufacturing within a pharmaceutical or life sciences environment
• Strong understanding of cGMP regulations, quality systems, regulatory inspections, and audit readiness
• Proven ability to lead technical teams, manage resources, resolve complex issues, and deliver results through others
• Experience designing or supporting GMP facilities, including collaboration with engineering and oversight of build‑out activities
• Effective communication and stakeholder management skills, including customer‑facing and cross‑functional collaboration
• A scientific degree or similar field required, with an emphasis on applying knowledge to advance drug product development

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.