5-7 years of experience in early-phase GMP drug product manufacturing/packaging.
Strong understanding of cGMP regulations and quality systems.
Proven leadership abilities in managing technical teams and resolving complex issues.
Experience in designing or supporting GMP facilities and engineering activities.
Excellent communication and stakeholder management skills.
A scientific degree is required, preferably in a relevant field.
15+ years of experience with a bachelor's or master's degree, or 10+ years with a PhD.
Responsibilities
Lead Product Development GMP manufacturing and packaging operations for early-phase clinical trials.
Oversee the design and maintenance of PD GMP spaces, including equipment selection.
Serve as the technical and operational Subject Matter Expert for PD GMP activities.
Provide leadership and management for a diverse technical team, focusing on development.
Ensure compliance with cGMPs, SOPs, safety standards, and maintain inspection readiness.
Act as a key stakeholder in regulatory audits, client meetings, and site visits.
Coordinate closely with cross-functional teams to ensure timely project delivery.
Benefits
Opportunities for growth in a dynamic Product Development environment.
Collaborative, inclusive, and ethical workplace culture.
Compensation programs recognizing high performance and leadership impact.
Competitive medical, dental, and vision insurance coverage.
Access to learning, development, and leadership programs at Lonza.
Full Job Description
Manager, Product Development 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 and packaging 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:
Significant experience in early-phase GMP drug product manufacturing and/or packaging within a pharmaceutical, OSD (Oral Solid Dosage) 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
Approximately 15+ years of relevant experience with a bachelor's or master's degree, or 10+ years with a PhD
About Lonza America Inc
Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
