Christopher Kozar Email & Phone Number

New Jersey, United States

At Insmed, I am responsible and accountable for the coordination and leadership of activities associated with driving Insmed’s assets through completion of development, regulatory submissions (NDA, MAAs and JNDA), supporting commercial launch and life cycle management indication development. I also lead all necessary strategic planning, risk management, operational execution and communication required for the successful and timely completion of cross-functional plans.

Nj

• Support the business development team in the scoping and communication of program details prior to contract execution• Lead the development of detailed project plans with clear targets for project milestones, including risks and mitigations• Create resource models and track and monitor resources associated with assigned program• Lead high-performing cross-functional teams• Serve as POC for client-facing communication• Make or facilitate the process of effective decision-making• Communicate with client sponsors and stakeholders as well as internal commercial teams to ensure the project remains aligned with both the client’s goals and the needs of the business

Florham Park, New Jersey, United States

• Manage and drive CMC strategy execution for NK cell therapies, CAR-T cell therapies, and tissue products• Develop CMC roadmaps and governance models• Support the clinical development and commercialization of cell therapies and tissue products in the pipeline• Partner with other leaders to ensure delivery of corporate goals and objectives

Princeton, New Jersey, United States

• Manage entire drug product portfolios and support their development throughout their lifecycles• Support the business by leading successful global drug product launches. Business domains include Oncology, Dermatology, Ophthalmology, and Long Term Care.• Build and maintain healthy and productive business relationships within and outside the organization• Develop and implement robust PMO processes and best practices throughout all cross-functional teams, including launch toolkit and framework

Greater New York City Area

• Support cross-functional teams, plan and execute a fully integrated CMC program (Pre-Candidate Nomination to IND to Phase I/II/III) and support commercialization of all programs• Lead the delivery of project milestones on time and within scope through utilization of project management standards• Organize and manage internal and external Global Project Teams• Build and maintain effective teams: motivate, recognize, coach & mentor team members

East Hanover, Nj

As a member of Novartis Technical Operations, I enabled the successful completion of technical development plans for various cell and gene therapy projects through executing, monitoring, and oversight of the implementation, tracking, and reporting of projects/change controls and key cross functional department activities. I worked closely with SME's from all functional areas to provide input to the overall project strategy.• Responsible for coordination and delivery of projects in support of key cell and gene therapy development programs from planning through implementation.• Support Technical Product Lead in creation and maintenance of Technical Development Plan• Lead preparation and facilitation of designated sub-team meetings, including action follow up and follow through.• Monitor development activities and prioritize project activities within project subteams. • Ensure alignment with functional groups (RegCMC, Quality, Manufacturing, Development, IT, Supply Chain) to ensure a systematic alignment of tasks and priorities to the overall technical development plan.• Provide oversight and authority for key developmental change controls, ensure thorough collaboration with the necessary team leads for accurate reporting, efficient execution, and on-time delivery. Ensure resource availability and allocation through details project planning and progress tracking.• Support Technical Product Lead in project and process reporting to various stakeholder groups.• Measure project performance and manage risk.• Provide input to contracts and QA-agreements with 3rd parties and support outsourced tasks/projects with 3rd parties as appropriate.

Summit, Nj

• Support the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers.• Management of laboratory equipment implementation and CSV projects including scheduling, procurement, site prep, installation, qualification, validation, and turn over to business area.• Maintain qualified equipment systems in compliance with policies and guidelines.• Develop and approve change controls, validation plans, qualification protocols, associated reports and procedures for laboratory and manufacturing equipment.• Review and execute equipment qualifications, validation protocols, and process improvement studies.• Mentor and train qualification specialists in calibration, equipment qualification and validation • Support internal customer groups in the procurement, operation, calibration and preventative maintenance of equipment to meet business needs in accordance with required schedules or dates.• Support compliance with Facilities Services Qualification Master Plan.• Schedule and perform periodic field reviews of qualified systems.• Contract with and supervise vendors for qualification and calibration • Conduct investigations into qualification failures and develop and implement remediation plans.• Assist with the development of operation, calibration, qualification and maintenance procedures for laboratory and manufacturing • Manage/support facilities new construction and relocation projects.

Warren, Nj

As part of a cross-functional technical operations team, I strived to overcome challenges and mitigate risks faced when implementing clinical and commercial processes for MSC's in large-scale bioreactor systems, CAR-T cells, NK cells, and human tissue-derived medical devices. In addition to GMP production duties within the laboratory, I qualified and maintained all GMP equipment associated with Manufacturing Operations including refrigeration, stability chambers, incubators, balances, dosing pumps, laser sealers, sterile welders/sealers, calibration standards, IP camera systems, Kaye Validator systems, bioreactors, centrifugation systems (continuous and non-continuous), and filter integrity testing systems. I also participated in process validation, risk assessment and FMEA, and facility design/engineering for all new GMP production.• Supervise GMP manufacturing activities within the lab• Lead efforts to improve GMP controls for equipment design input, qualification, calibration, and repair program by working cross functionally with Laboratory Systems Management and Quality Assurance• Manufacturing Lead for tech transfer efforts for GMP NK cell process, working with Bioprocess Development and QA• Act as lead GMP Operator for NK cell project and serve as primary GMP representative for early development/GMP adaption• Train new manufacturing operators on GMP processes

Warren, Nj

• Design, author, and execute all internal validation/qualification protocols• Manage change control and lifecycle of all qualification documents throughout approval• Manage building environmental monitoring system for GMP facility• Participate in tech transfer efforts from process development to manufacturing• Conduct facility validation studies and implement new technologies to increase compliance• Participate in internal and external audits and implement response to findings

Warren, Nj

• Aseptic manufacturing of cell therapies for use in ongoing clinical programs• Operate and maintain ISO 5 and Class A clean rooms in accordance with cGMP’s• Write and adhere to SOP’s and batch records• Investigate non-conformances and implement CAPA’s• Developed calibration program for GMP equipment and maintained equipment across facilityResearch and Development Activities:• Assist with investigation into new indications for Celgene’s primary cell-based therapies• Concentration in neurodegenerative disease• Fix and process animal tissue and perform immunohistochemistry• 2D and 3D imaging and analysis of tissue

Rutgers University, New Brunswick, Nj

- Founding member of GEARS- Vice President, GEARS- Participated in iGEM, International Genetically Engineered Machine Competition- Applied synthetic and molecular biology techniques to create novel ideas with practical application

Department Of Plant Biology And Pathology

- Assisted in various research projects involving the pathogenicity of Lysobacter enzymogenes - Gained skill in molecular-based techniques- Participated in general laboratory maintenance, including growth media and reagent preparation

Langhorne, Pa

- Conducted research under cGLP conditions including a cell infiltration study with Xylos' patented medical devices- Duties included designing and performing experiments, mammalian cell culture, small scale aseptic processing, and buffer and media preparation

Master’S Degree, Project Management

Graduate Certificate, Project Management

B.S., Biotechnology/Biochemistry

Activities and Societies: GEARS, iGEM

A.S, Biotechnology