Manager Product Development GMP Operations

The site supports customers throughout the drug development lifecycle while offering employees the opportunity to work with advanced technologies in a collaborative, quality-driven environment that directly impacts patient health worldwide. The Manager, Product Development GMP Operations is a site based leadership role supporting early phase clinical trial drug product manufacturing and packaging.

Manager, Product Development GMP Operations

Location: Tampa, FL
Industry: Pharmaceutical
Hours: M-F, 8am-5pm, on-site 100%
Salary: Competitive industry compensation package (relocation assistance offered for the right candidate)
Employment Type: Direct hire

Company overview:
We are a manufacturing site specializes in cGMP formulation development, clinical supply, and commercial manufacturing for oral solid dosage and inhalation products. The site supports customers throughout the drug development lifecycle while offering employees the opportunity to work with advanced technologies in a collaborative, quality-driven environment that directly impacts patient health worldwide.

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.

Responsibilities:

• 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 our learning, development, and leadership programs
• 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

Qualifications:

• Significant experience in early phase GMP drug product manufacturing and/or packaging within a pharmaceutical or life sciences environment
• OSD (oral solid dosage) experience is a must
• 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

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