Project Manager, Program Management

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.

For more information, please visit our website at www.kincellbio.com.

Kincell is seeking a highly motivated Project Manager who will be a key contributor to a dynamic and collaborative Project & Program Management team.

The project manager’s role is charged with delivering consistent project 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 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 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 project manager will integrate scientific and business priorities to drive effective delivery of the program deliverables. The Client 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 project manager will play a critical role in the resource/financial management and forecasting of individual projects on an ongoing basis.

Essential Duties and 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.

• Ensure customer project activities, milestones, and deliverables are planned and executed to a high standard.
• Management of a portfolio of complex multi-service projects, ensuring a consistent approach by using approved templates and process flows.
• Lead cross-functional project teams to ensure development and execution of project plans and alignment of project goals.
• Utilize tools and procedures for monitoring and driving project progress, intervention, and problem solving within the project team and broader Kincell Bio organization.
• Develop and maintain clear full life-cycle project management plans for projects using standard tools (e.g., Microsoft Project) in consultation with project teams.
• Track timelines and project metrics through the course of projects.
• Work with departments leads to ensure optimal capacity and project planning.
• 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.
• Facilitate communication across all project stakeholders and engage with a solution-oriented focus.
• Facilitate meetings, producing timely minutes and follow-up action items.
• 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.

• Qualified to degree level, or equivalent, in a related discipline (science, business, etc.)
• 4+ years or equivalent related experience managing multi-disciplinary pharmaceutical development/manufacturing or CMC project teams.
• Project Management Certification: PRINCE 2, PMP, or equivalent is desirable, with working knowledge of associated methodologies and principles.
• Good working knowledge of contract biopharmaceutical development and manufacturing services and the pharmaceutical and biotech industries
• Knowledge of the drug development process
• Previous proven experience in a project management role
• Excellent IT skills, particularly MS Office Excel, Word, Project, and Smartsheet
• Experience with ERP systems (Oracle, SAP, etc.) desirable.
• Commercial & financial acumen and ability to track costs/budgets/financial reporting relating to project execution.
• Experience managing customers and associated skills.
• Able to communicate and work with all levels of organizations, internally and externally.
• Resourceful and able to make sound decisions when facing ambiguity.
• Proven flexibility in adapting to a rapidly evolving workload.
• Excellent verbal, written, and presentation skills.
• Demonstrated proactive and organized approach, able to influence cross-functionally, and proven ability to prioritize and manage multiple tasks.

Physical Demands

• Adjusting or moving objects weighing up to 25lbs

Travel Requirements

• N/A

Location

• This is a 100% site-based position located in RTP, NC, and it will require some non-standard working hours, including early morning or late evening.

#Li-Onsite

Kincell Bio 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. Kincell Bio 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: Kincell Bio 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.