• Lead a team of technical experts to develop/validate/transfer analytical methods (with chromatographic focus) to support enterprise small-molecule portfolio.• Oversee reference standard management• Oversee and coordinate all aspects of assigned program/project • Analyze the overall data generated on development and clinical supply samples• Develop strategy for regulatory submissions• Develop, review, and approve source documents for regulatory submissions• Author, review, and approves SOPs, analytical methods, protocols, and reports• Identify and manage external collaborative development• Responsible for staffing, operational, and capital budgets

• Head of Analytical Development• Lead the analytical development of small molecule candidates from discovery through NDA for both drug substances and drug products, as well as the life-cycle management of commercial products. • Direct and manage the internal analytical development laboratory (with 8 direct reports) and oversee work at external partners (with a large number of FTEs at CROs and CMOs)• Work in a fast-paced environment and engage with cross-functional teams to accelerate drug development of a variety of dosage forms at different phases• Coordinate with QA and Regulatory, as well as other CMC functions, Clinical and Toxicology regarding safety-related questions on APIs, components of APIs and formulations and materials

DPDS (Discovery, Product Development and Supplies), CPDS (Chemical and Pharmaceutical Development & Supply), Analytical Development -External Analytics • Responsible for project management and oversight of external laboratory activities based in the Americas, ensuring that all AD related activities are conducted according to project plans and internal requirements • Provide expertise and guidance in method development, validation, investigation, and analytical transfer to support in all phases of pharmaceutical development including product life cycle management• Manage project priorities and resource utilization in the external labs• Escalate potential issues to management and serves as coordinator in crisis management situations • Provide technical support of analytical methods for marketed products to JSC in the Americas and Regulatory Affairs for agreed portfolio • Support audits and regulatory submissions. Partner with production sites and other global AD groups on issues related to test methods and facilitate in the resolution • Support Due Diligence activities by providing analytical expertise for evaluation of external assets and partnerships• Work closely with Analytical Scientific Integrators and sub-team members to develop external laboratory project workflow and timelines and ensure project deliverables are met on time with high quality• Interact with multidisciplinary and multi-site groups, including external vendors and/or strategic suppliers• Maintain key interactions with Scientific Integrators and other department leaders, technical groups, regulatory organizations, quality, & external partners• Provide input as needed to support major and/or minor filings for new products and life cycle management

•Supervise a group of up to 7 scientists at AD-Titusville and directed analytical development activities including end-to-end analytical development and lifecycle management of active pharmaceutical ingredients and pharmaceutical finished products•Direct end-to-end method development, qualification/validation, transfer and life-cycle management (such as HPLC, UHPLC, GC, KF) •Providing input for the preparation and updates of the regulatory filings •Manage external partners in technical support of the analytical methods for products in various development phase and marketed products•Approve test methods, validation/transfer protocols/reports, technical reports such as investigation/gap assessment reports.•Supervise lab investigation, SOP writing, data-reviewing under GMPs•Serve as AD Liaison to CRO/CMO

Serve as an Analytical Development – Technical Owner, responsible for the fast and successful completion of development and lifecycle management programs including: • Science/risk based management of specification setting for APIs, intermediates, starting materials and commercial drug products; • Issuance of Specification Justification reports through consolidation of development or post-approval information and reports for the marketed products manufactured at the JSC sites and at third party suppliers; • Advise technical teams on API and drug product control strategy, specification and analytical issues; • Ensure the proper and timely preparation of specification reports and other documents; • Critical evaluation and interpretation of current files and data; • Planning, coordination, tracking, execution and closure of the change control records for new analytical proposals; • Answer questions, complaints, remarks or suggestions related to specifications from regulatory authorities and/or affiliates; • Prepare and support Health Authority inspections and customer audits for assigned portfolio; • Participate as a technical team member in compliance and/or process improvement initiatives and project teams as related to specifications and analytical maintenance; • Provide input for delisting and divesting decisions;• Participate in compliance improvement initiatives and Project teams as related to LCM, specifications and internal compendia harmonization.

•Supervised a group of up to 8 scientists within Analytical R&D at multiple sites and directed analytical development activities including method development, validation and transfer (HPLC, GC, UV, GC/MS, LC/MS, TOC, KF, dissolution/elution), release testing, lab investigations, complaint and counterfeit investigations, trouble-shooting, SOP writing, data-reviewing, internal audit and stability management under GMPs. Proficient in working in a consent decree environment.•Led multiple collaborative projects with Janssen Pharmaceutical, J&J Consumer, McNeil Canada, Cordis and J&J Supply Chain. Responsible for project management in terms of capacity assessment, resource planning, results delivery and working with multi-site team to ensure all critical timelines are met. •Key player in successfully negotiating requirements on analytical testing for combination products with the Chinese sFDA. •Managed multiple contract labs (CROs) by initiating contracts, reviewing data and protocols and resolving technical issues. •Led the development and validation of analytical method activities on small molecules and large molecules for pharmaceuticals, consumer products and medical device/combination products.•Authored numerous technical reports such as test methods, validation protocols and reports, stability protocols and reports and reviewed CMC sections for regulatory filings. •Presented more than 40 papers internally and externally, often as invited speaker and published 23 scientific papers on peer-reviewed journals. Authored three scientific book chapters on analytical chemistry. Authored scientific reports for inclusion into IDEs, PMAs and PAS to satisfy FDA approval requirements.•Led R&D/QA/QC analytical interface team to exchange technical transfer information and provide a forum to discuss and solve transferred product-related issues.

•Served as Analytical Development Team Representative (ADTR) on multiple projects.•Coordinated and served as the single point of contact to ChemPharm project team for all analytical activities. •Served as representative for Drug Product group on 10 projects. Responsible for method development for drug product over the entire drug development process, excipient compatibility studies, probe stability studies, forced decomposition studies, and direct support to the department of Pharmaceutical Development. •Supervised a group of up to 7 scientists in the area of HPLC method development and validation. Responsible for planning the workload within the group, interacting with Technical Team Leader or function head of other units throughout the process, trouble-shooting of technical issues, reviewing all technical reports within the group and ensuring project timelines were met for multiple projects. •Authored CMC section of IND and NDA filings.•Developed HPLC methods, such as assay/impurity, content uniformity and chiral analysis, for drug substances and formulations.

•Developed HPLC assay/purity and chiral methods for analysis of various intermediates/ reagents, bulk drugs and formulations in support of early development, post-IND and in-process manufacturing phases. •Developed residual solvent methods (GC) for drug substances. Methods are developed/validated and documented in support of IND filings. •Coordinated project-related activities within Analytical R&D and interacted with project managers and other functional units. •Supervised one technician to conduct method validation and sample analysis. •Established and led a community of separation science-chiral separation group which served as a forum for exchange of information and offered many internal and external trainings/presentations.

•Developed chiral HPLC methods for analytical and preparative scale applications.

•Developed and validated analytical methods such as titration, GC, HPLC, viscosity, UV-VIS (color analysis), in support of consumer product formulation. •Trained junior personnel in R&D and QA/QC groups. Presented/published papers internally and externally.