Biotech Senior Project Manager, CMC & GMP Programs

Kincell Bio; Gainesville (FL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Job summary

Kincell Bio in Gainesville, FL is seeking a Senior Project Manager to lead cross-functional programs in biologics development and GMP manufacturing. You will drive project plans, manage timelines and budgets, and ensure delivery to client programs.

The role requires deep experience in drug substance and/or drug product development, strong stakeholder management, and the ability to mentor junior PMs. Occasional travel to support vendors and clients is expected.

Qualifications

• Bachelor's degree in life sciences, engineering, business, or a related discipline; advanced degree or PMP certification preferred.
• 6+ years or equivalent related experience managing multi-disciplinary pharmaceutical development/manufacturing or CMC project teams.
• Demonstrated success leading complex 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 is desirable, with working knowledge of associated methodologies and principles.
• Experience managing customers and associated skills.
• Resourceful and able to make sound decisions when facing ambiguity.
• Experience managing project budgets, schedules, risks, resources, vendors, and executive-level reporting.

Responsibilities

• Lead a portfolio of complex operational projects such as facility and capacity expansions, major 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 stakeholder 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 effective 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, according to defined communication plans and contact matrices.
• 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, where appropriate, ensuring any lessons learned are implemented to improve time, scope, cost, and customer satisfaction outcomes on subsequent projects.
• Demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvements.
• Other duties assigned.

Job description

Kincell Bio in Gainesville, FL is seeking a Senior Project Manager to lead cross-functional programs in biologics development and GMP manufacturing. You will drive project plans, manage timelines and budgets, and ensure delivery to client programs.

The role requires deep experience in drug substance and/or drug product development, strong stakeholder management, and the ability to mentor junior PMs. Occasional travel to support vendors and clients is expected.