Sr. Project Manager, Operations

Kincell Bio, LLC•Gainesville, FL

1d•Onsite

About The Position

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, apply expertise in analytical and process development and GMP manufacturing, testing and release from early clinical to pivotal studies and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCR, TILs, Tregs and CAR-NK technologies. We offer challenging career opportunities, competitive benefits, and an environment that recognizes and rewards performance. Kincell is seeking a highly motivated Sr. Project Manager who will be a key contributor to a dynamic and collaborative Project & Program Management team. The senior project manager role is charged with delivering consistent project and program management on behalf of our customers, acting as their internal advocate within Kincell Bio, representing the voice of the customer, and ensuring effective cross-functional project and resource management. The senior project manager will have a strong background in biologic drug substance and/or drug product development, enabling them to credibly work with customers and department heads to drive programs through the critical path of process development and GMP manufacturing. The senior project manager will devise, integrate, and execute high-quality, cross-functional project plans that reflect the specific goals of each customer program. In collaboration with our customers, internal functional leaders, and scientific subject matter experts, the senior project manager will integrate scientific and business priorities to drive effective delivery of the program deliverables. The Client's senior project manager will be responsible for establishing effective teamwork, executing the program strategy, providing project leadership, and facilitating effective and proactive information exchange, identifying and resolving/mitigating project-related risks, and managing timelines and budgets. Additionally, the senior project manager will play a critical role in the resource/financial management and forecasting of individual projects on an ongoing basis.

Requirements

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
Good working knowledge of contract biopharmaceutical development and manufacturing services and the pharmaceutical and biotech industries
Experience managing project budgets, schedules, risks, resources, vendors, and executive-level reporting.
Ability to influence across technical and business functions and to drive decisions in a matrixed, fast-changing environment.
Strong written, verbal, facilitation, presentation, analytical, and problem-solving skills.
Proficiency with Microsoft Office and project-management tools; ERP, eQMS, MES, LIMS, or related enterprise-system experience preferred.

Nice To Haves

advanced degree or PMP certification preferred.
Project Management Certification: PRINCE 2, PMP, or equivalent is desirable, with working knowledge of associated methodologies and principles.
ERP, eQMS, MES, LIMS, or related enterprise-system experience preferred.

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.