Senior Biotech Program Manager — GMP/CMC Leadership

Kincell Bio, LLC; Gainesville (FL); On-site; USD 110,000 - 140,000; Full time

Job summary

Kincell Bio in Gainesville, FL seeks a highly motivated Senior Project Manager to join the Project & Program Management team. You will deliver cross-functional project plans for biologics development and GMP manufacturing, acting as the customer advocate and driving programs through critical paths with senior leadership.

The role emphasizes managing budgets, timelines, risks, and resources, mentoring junior PMs, and collaborating with Manufacturing, QA, Regulatory, and Finance to ensure

Qualifications

• Bachelor's degree in life sciences, engineering, or business; advanced degree or PMP preferred.
• 6+ years managing multi-disciplinary pharmaceutical development/manufacturing or CMC project teams.
• Proven success leading cross-functional operational, technical transfer, CAPEX, digital, or readiness programs in a regulated GxP setting.
• Strong understanding of GMP operations, quality systems, validation/qualification, change control, manufacturing readiness, and cross-functional dependencies.
• Project Management Certification: PRINCE 2, PMP, or equivalent desirable.
• Experience managing customers and associated skills; ability to influence across functions.

Responsibilities

• Lead a portfolio of complex operational projects such as facility expansions, CAPEX, technology transfers, process readiness, inspection readiness, business continuity, and enterprise system implementations.
• Develop integrated project strategies and detailed plans covering scope, schedule, critical path, resources, budget, dependencies, risks, quality-system requirements, and governance.
• Lead cross-functional teams spanning Manufacturing, MSAT, QA, QC, Supply Chain, Facilities/Engineering, Validation, IT, Finance, Regulatory/CMC, and Commercial functions.
• Establish project governance and facilitate decision-making, escalation, action tracking, and executive reporting.
• Partner with Quality and technical SMEs to integrate change control, qualification/validation, training, documentation, and readiness activities into project plans.
• Identify resource and capacity constraints, evaluate schedule impacts, and drive mitigation plans with functional leadership.
• Manage project budgets, forecasts, purchase commitments, and financial performance in partnership with Finance and project sponsors.
• Maintain project schedules, dashboards, risk registers, decision logs, and lessons learned using approved project-management tools.
• Lead operational workstreams supporting client technology transfer, GMP readiness, campaign execution, or commercialization where coordinated delivery is required.
• As the primary liaison between the project team and the client, facilitate client project meetings and communication throughout the project lifecycle.
• Mentor less-experienced project managers and contribute to standardization and continuous improvement of Kincell project-management practices.
• Manage the scope change-related contract maintenance process according to standard templates and business processes.
• Maintain accurate tracking of revenue and billing associated with projects and proactively participate in routine tracking and review meetings.
• Review and reconcile project budgets.
• Identify lessons learned and lead close-out meetings with the client and the project team.

Skills

Cross-functional leadership

Stakeholder management

Analytical thinking

Risk management

Education

Bachelor's degree in life sciences, engineering, or business

Advanced degree or PMP/PM certification preferred

Tools

Microsoft Office

ERP

eQMS

MES

LIMS

Job description

Kincell Bio in Gainesville, FL seeks a highly motivated Senior Project Manager to join the Project & Program Management team. You will deliver cross-functional project plans for biologics development and GMP manufacturing, acting as the customer advocate and driving programs through critical paths with senior leadership.

The role emphasizes managing budgets, timelines, risks, and resources, mentoring junior PMs, and collaborating with Manufacturing, QA, Regulatory, and Finance to ensure