CMC Project ManagementOperational ProjectsPharmaceutical Development and Manufacturing
Useful technologies
Microsoft Office
Required qualifications
Field of studyBusiness, Engineering, Life Sciences (or related)
Study levelBachelor's
Preferred qualifications
CertificationsProject Management Professional, Prince 2
Original posting
Kincellis Advanced Therapies is a U.S.-based contract development and manufacturing organization supporting advanced-therapy developers from early-stage CMC, process and analytical development through clinical supply, pivotal-stage programs and commercial supply. With facilities in Gainesville, Florida; Research Triangle Park, North Carolina; and The Woodlands, Texas, Kincellis combines broad technical expertise with flexible, scalable GMP infrastructure across autologous and allogeneic therapies, including but not limited to CAR-T, Tregs, CAR-NK, MSCs, dendritic cell vaccines, exosomes, iPSCs & synthetic mRNA.
For more information, visit our website at www.kincellis.com.
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.
Essential Dutiesand Responsibilities
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.
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.
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.
Qualifications
The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.
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
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.
Physical Demands
Adjusting or moving objects weighing up to 25lbs
Travel Requirements
Occasional travel may be required, including travel between Kincell sites and to support vendors or clients.
Location
This is a site-based position located in Gainesville, FL, and it will require some non-standard working hours, including early morning or late evening.
#LI-Onsite
Kincellis Advanced Therapies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable, federal, state, and local laws. Kincellis Advanced Therapies complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
NOTE TO EMPLOYMENT AGENCIES: Kincellis Advanced Therapies values our relationships with our Recruitment Partners. We will only accept resumes from those partners who have been contracted by a member of our Human Resources team to collaborate with us. We are not responsible for any fees related to resumes that are unsolicited or are received without contract.