Product Development Manager GMP Operations

Lonza Biologics, Inc.; Tampa (FL); On-site; Confidential; Full time

Benefits offered by this job

Relocation assistance

Career development programs

Competitive benefits

Job summary

Lonza Biologics, Inc. in Tampa, FL is seeking a Product Development Manager for GMP Operations to lead early‑phase drug product manufacturing and packaging, overseeing PD GMP spaces, equipment selection, and engineering build‑outs.

You will guide cross‑functional teams, ensure cGMP compliance, readiness for inspections, and collaborate with quality, manufacturing, and project groups to deliver timely, cost‑effective work. A Ph.D. or M.S. in science with 10+ years in GMP environments is required.

Qualifications

• 10+ years of experience in early‑phase GMP drug product manufacturing.
• Strong understanding of cGMP regulations and audit readiness.
• Scientific degree required with emphasis on applying knowledge to drug product development.

Responsibilities

• Lead and develop PD GMP manufacturing operations for early‑phase drug products.
• Design, oversee, and maintain PD GMP spaces, including equipment selection and engineering build‑outs.
• Serve as SME for PD GMP activities, supporting projects and new technologies.

Skills

Leadership

GMP knowledge

Regulatory knowledge

Stakeholder management

Communication

Education

MS or PhD in science

Tools

Engineering drawings

Quality systems

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.