Jack Greene leads the Drug Substance, Drug Product, and CMC Regulatory teams at JucaBio as CTMO. He has experience with cross-functional teams to ensure that CMC meets the material and documentation needs of Quality, Clinical, Nonclincial and Regulatory Affairs. He has 25 years of experience in the pharmaceutical industry, in multiple areas, including process development for both NCE and biologic drug substances, formulation development for oral, parenteral, and inhalation drug products, and CMC regulatory strategy and submissions. He has been a lead strategist and author for Phase 1-3 IND and NDA submissions, a de novo device submission to CDRH, and an FCN submission to CFSAN. His expertise extends to managing analytical development, quality control, product characterization, integrated commissioning and qualification of manufacturing plants, process control system design, and the implementation of enterprise-level computer systems.

Responsible for process development, scale-up and manufacturing of both Drug Substances and Drug Products. This includes:• Management of the overall clinical trial material production timeline to meet corporate goals• Partnering with internal and external Quality organizations to set clear expectations for all GMP activities• Development of Target Product Profiles (TPP). Deriving Drug Product and Drug Substance Critical Quality Attributes.• Designing development programs to define process design spaces that support QbD IND filings and maximize downstream flexibility.• Selecting CMO’s for scale-up based upon short, medium and long term goals including process capability, cost effectiveness and long term strategic alignment• Managing analytical development for both Characterization Tests and Release Assays as well at multiple external laboratories• Performing technology transfer of processes and analytical methods to multiple CDMO/CMO’s• Writing Drug Substance and Drug Product CMC sections of the IND/IMPD using a CTD format

Responsible for process development and scale-up and manufacturing of biologic-derived API’s and Drug Products. This includes:• Development of Target Product Profiles (TPP). Deriving Drug Product and API Critical Quality Attributes.• Designing development programs to define process design spaces that support QbD IND filings and maximize downstream flexibility.• Selecting CMO’s for scale-up based upon short, medium and long term goals including process capability, cost effectiveness and long term strategic alignment• Managing execution of analytical tests at multiple laboratories to support process design decisions• Performing technology transfer of processes and analytical methods to multiple CMO’s and management of clinical trial material production• Writing API and Drug Product CMC sections of the IND using a CTD format• Partnering with internal and external Quality organizations to set clear expectations for all GMP activities

Directed an integrated development strategy for a De Novo Class II medical device to be used in combination with a novel functionalized food contact polymer. Interfaced directly with other key stakeholders including Preclinical, Clinical and Regulatory to ensure that material production goals as well as CMC related regulatory filings were written and submitted per the project plan. This includes:• Selecting CMO’s for production of Food Contact Materials and Medical Device Molding/Assembly based upon short, medium and long term goals including process capability, cost effectiveness and long term strategic alignment• Managing execution of analytical tests at multiple laboratories to support process design decisions• Performing technology transfer of processes and analytical methods to multiple CMO’s and management of clinical trial material production• Authoring a Food Contact Notification for a novel Food Contact Substance using FDA form 3480. Received approval from CFSAN (FCN-1498) to market iLipase®, a novel polymer designed to contact food.• Authored all chemistry aspects of a De Novo Class 2 medical device filing using a novel food contact polymer. Received approval from CDRH to market RELiZORB®, an Enzyme Packed Cartridge per 21 CFR 876.5985.• Partnering with internal and external Quality organizations to set clear expectations for all GMP activities• Managed Technology Transfer of processes and analytical methods to multiple CMO’s to enable on-time non-clinical and clinical timelines• Managed day to day aspects of the corporate supply chain.

Used ASTM-E-2500 to develop an integrated Commissioning, Qualification and Validation for Capital Improvement projects at a manufacturing facility under FDA consent decree. Developed installation and operational commissioning protocols. Managed C&Q timelines/resources. Coordinated with internal and third party stakeholders.• Developed standardized commissioning, qualification and validation plans that apply guidance from ASTM-2500 to implement corporate goals to improve quality and reduce implementation time• Developed integrated installation and operational commissioning templates for capital projects as well as smaller change control driven improvements• Developed agreements with the process validation team as to the level of testing performed in commissioning to ensure a smooth handoff and prevent project delays• Worked closely with third party certifiers as required by the FDA consent decree to ensure that all plans, protocols and reports align with industry standard practice• Applied this scheme to equipment upgrade projects, change controls as well as implementation of single use disposables

Used QBD approach to assess 10 years of Development History for three enzyme based API’s. Wrote CMC sections of the NDA using a CTD format. Supervised PAI preparation activities at multiple contract sites. Drafted responses to all CMC Chemistry Reviewer questions. Defended the data supporting the design space and the in-process specification at PAI. Wrote 483 responses and coordinated corrective actions. Wrote responses to all FDA chemistry reviewer questions regarding API

Responsible for managing Contract Manufacturing Organizations. Led manufacturing investigations to assign root cause and developed change controls to implement process improvements. Designed tools to automatically extract critical manufacturing data to speed batch record review. Developed integrated C&Q master plans and protocols for new processes.

Responsible for assisting Engineering, Quality Systems and Manufacturing in the design and documentation of new GxP laboratory and manufacturing data systems. Responsible for Validation of existing GxP systems and of the maintaining these systems in that state via Change Control