Direct and manage all CMC related and quality activites to support our products in differenct phases of clinical trials.

Speaker for ICH Q1B Photostability interpretation and Technology Transfer.

Provide GXP and regulatory consuliting services on a variety of partner business needs. Resolve issues and meet expectations.

Provide oversight of Drug Substance and Drug Product Stability Programs. Data review and compliance.

Collaboration with BD/Sales VP for generation of a RFP/proposal process from inception. Generation of documents and client ready materials/presentations. Generation of pricing structure. CMC Development Group. Program Management and technical input for early-phase CMC Clinical Development programs. Collaborate with BD Management /Sales on proposal generation from RFI/RFP. Multiple programs simultaneously. Execute program launch and site preparation (resources/equipment). Manage program material sourcing, technical deliverables/protocols/reports, GxP documentation in Veeva Vault, CMC Regulatory documentation for input into eCTD, ICH stability programs, overall timelines, budget, updates to Leadership, data/document uploads to SharePoint. Presentation of final results to client. Questionnaire for process improvements. NDA filing for oral product, Elemental Impurities. Management of Elemental impurities risk assessment for product and process. Changes made to two raw materials and manufacturing parts as part of the submission. Removed deficiency risk for Elemental Impurities. Program Management of Capital project (2M). Construction of new laboratory and manufacturing suites. Equipment procurement and qualification. Part 11 compliant data systems validation. CoLeader of cross-functional team to address GxP Quality Management System (QMA) gaps and inefficiencies. Change Control processes for Manufacturing Operations equipment cleaning, and phase-appropriate raw material testing and release practices.

Independent consultant working with c-suite leadership team to address CMC and QMS challenges to improve the bottom line of the business and audit record. Conducted gap analysis and impact assessment of CMC work and QMS. Generated value proposition and change management plan for leadership review that included: findings, resource needs, budget, and charter for a 1 year remediation plan to address the following:> Revamp of entire SOP platform: organizational structure, complexity and number>Revamp of entire Training platform: Accountability practices, instituted Proof-of-concept training modules, tests for SOPs>Analytical testing: removed test into compliance practices, Instituted ALCOA based notebook practices, cleaning validation approach and limit calculation practices. >Manufacturing: revamp of batch record format, new approach to equipment cleaning.>Program Management for 21CFR part 11 compliance validation of Empower 3 chromatography system>Approach to CMC regulatory filings approach. ICH Q8, documentation practices, risk management>200 deviations and CAPAs on the books. Resolve.After 1 year:>training failures and training related deviations reduced by 90%>process recleaning rate reduced by 90%>Empower Validated>Historical deviations and CAPAs were resolved. Timing requirements written into SOPs>Batch record execution and deviations reduced by 90%>Instituted QA audit program with Leadership sponsorship. Wrote Quality policy.>Audit findings from data integrity and notebooks were reduced by 90%>Expectations of the client were met.

Chemistry and Analytical Sciences (CAS) Drug Development Group. Conduct CMC Clinical Drug Development on multiple small molecule programs in different delivery systems. CoLead and SME on project teams. Management of a group of Chemists. Method development and validation. Formal ICH Stability programs / stability summaries. Critical review and approval of protocols, reports, specifications. GxP documentation. Regulatory submission documentation for NDA/aNDA, eCTD modules 2,3. CoLead on task force team of Capital project. New laboratory and manufacturing suites (20M). Equipment procurement and qualification. Casework selection. Building commissioning. 21 CFR Part 11 compliant data systems, installation and validation. Project ran ontime and onbudget.Interpretation of ICH Q1B photostability guidance for internal groups and external partners.Conduct Virtual Drug Development. CoLead on cross-functional team for seven aNDA programs running simultaneously. Vendor ID and selection, contract management. Governance model. Technical oversight of CMC and QMS activities. All programs ran on time and on budgetQMS electronic data system file compatibility team. Assist internal IT with data files type compatibility with internal and external software for reduction in data management issues. Generation of corporate policy for governance of requirements and security.

Core Leadership team for the CDMO startup. cGMP capital project. New laboratory and manufacturing suites (2M). Equipment procurement and qualification. Building commissioning. Generation of a GxP Quality Management System (QMS) from inception. >200 SOPs. Met the rigor of FDA and client audits. Instrument and equipment qualifications IQ/PQ/PQ. 21CFR part 11 compliant electronic data systems/software. Establishment of Business Development model and pricing structure. Business launch. Participation in client and agency audits.Analytical Services Group. Management of a cGMP compliant laboratory providing manufacturing support. Management of a team of Chemists. Research and Quality Control activities. Method development and validation. Formal stability study management. GxP documentations. Manufacturing in-process and release tesing. Design space and QbD studies. Technology transfer of methods and processes. Contributions to client aNDA/NDA CMC Regulatory submission in eCTD format. RFI/RFP. Critical review of client proposal documents. Participate in client meetings to resolve technical program challenges. Provide clients with program progress updates and presentation of final results.Interpretaton of ICH Q1B guidance for clients and university partners.Successful SUPAC technology transfer of Seromycin from Lilly to TCC. Orphan drug. PAS regulatory requirements. Transfer successful. Industrial Pharmacy Programs and Training. Direct oversight of Purdue pharmacy students conducting Industrial Pharmacy research as part of the Pharm D program. Management of their presentation for Purdue Pharmacy School credit (26 students).

Lilly Bioproduct Research Division. Conduct CMC Drug Development on multiple large molecule biopharmaceutical programs in different delivery systems. Analytical/BioAnalytical method development and validation for a multitude of techniques. Formulation Development and Manufacturing Operations support: DOE, filling line clearance micro testing, sterility micro testing, in-process and final release testing. Technology transfer of methods and process to two different partner companies, successful. Technology transfer of bioanalytical methods to internal Lilly QC, successful.IND/BLA CMC regulatory submissions. Generate responses to agency deficiency comments. Market product approvals, Gemzar, Humulin, hGh, Cialis Technical expertise in interpretation of ICH Q1B photostability guidance for internal groups and external partners. Quality System Management (QMS). Departmental cGMP advocate. Review of GMP trends document, review of departmental deviations and CAPA. Work with QA team for timely resolution. Corporate technology advancement in-liesencing review and development team. Vet new technology and drug development programs from nonLilly organizations for possible program purchase by Lilly. Lilly Research Laboratories Presidents Award for revalidation of a coagulation potency assay for a BLA. Regulatory submission documentation, FDA questions. Product approved, Xigris for late stage sepsis.

Core leadership team for the CDMO startup. Preparation of laboratory and manufacturing suites for qualification. Generation of a GxP Quality Management System (QMS) from inception. >200 SOPs. 21CFR part 11 compliant data base and software installation and validation. Met rigor of multiple client and agency audits. Business launch. Establishment of business development model and pricing structure.Pharma Services Group. Conduct CMC Drug Development on multiple small molecule pharmaceutical products in different delivery systems. Management of a team of Chemists. Analytical method development and validation. Formal Stability studies design and managment. Critical review and approval of notebooks, test methods, protocols, reports, specifications. DEA controlled substance inventory. Employee proof-of-concept training. Formulation development studies: phase solubility, solid-state characterization, excipient compatibility, stress testing, pKa/ LogD, acquire and interpret isotherms, water sorption and phase partition data for drug substances. Manufacturing support for process optimization, DOE, process validation. Technology transfer. Contributions to client CMC regulatory submissions for aNDAs/NDAs.Technical expertise for interpretation of ICH Q1B photostability studies for clients. RFI/RFP. Critical review of client proposals. Participant in client meetings to discuss technical program challenges and results. Provide program progress updates to client and presentation of final results.