January 2024; Director Analytical Services: Manage all aspects of analytical chemistry for The Ritedose Corporation including a dedicated team of 40+ scientists and leaders supporting commercial quality control testing (BFS and 503B finished product and raw materials, and data quality and compliance), as well as analytical methods development and validation activities.  January 2019 to January 2024; Director Analytical Development: Within TRC’s CDMO division, led a team of 15+ scientists in the development of traditional and complex (emulsions, suspensions, etc.) sterile pulmonary and ophthalmic drugs filled using blow-fill-seal (BFS) technology. Manage on-site and contracted off-site laboratory method development and ICH validation activities for numerous projects from early-stage feasibility to regulatory filing. Support NDA, ANDA filings, clinical trials, and US, EU, and ROW regulatory responses.Provide leadership and oversight in all aspects of analytical communication and transfer activities to customers and sub-contracted testing labs. Oversight of container closure E&L, elemental impurities, inhalation testing via NGI and breathing simulation, cleaning verifications, IVBE studies, temperature cycling, and photostability evaluations.

Led a team of Analytical Scientists in support of liposomal drug delivery product development and establishment of a quality control testing laboratory in preparation for regulatory submission for new cost-effective treatment options in the liposomal drug delivery space. Responsibilities included CDS validation and test method validation oversight, arrangement for contract lab testing and quality auditing, site GMP training, and laboratory team management.

Led a team of analytical scientists in the development of complex (emulsions, suspensions, etc.) generic sterile injectables. Managed on-site laboratory method development and off-site validation activities for 10 projects from early-stage feasibility to regulatory filing. Supported two ANDA filings, two clinical trials, and four IR/CRL responses.Performed assessments of external CMO laboratories for compliance and expectations alignment.Provided leadership and oversight in all aspects of analytical communication and transfer activities to contract labs and CMOs. Technical oversight of container E&L, Elemental Impurities, CCIT, Cleaning Verification, Temperature Cycling, and Photostability evaluations and validations. Improved laboratory throughput and compliance by institution and leadership of a team of SMEs focused on improvements in instrumentation performance.

Responsible for managing the AR&D laboratory, personnel, and equipment used in the development of novel implantable drug delivery technologies, and ensuring that the goals of the analytical group are aligned with the goals of the department and the company.Collaborated on the departmental budget and achieved numerous cost efficiencies within the AR&D group, including the institution of a third party enterprise resource management program for a significant cost savings compared to individual OEM contracts.Collaborated with clinical, formulations, and regulatory personnel in the submission of four IND submissions and one NDA.Directed the laboratory through a transition from a “research only” facility to the level of compliance required for late-stage clinical testing and release. Managed the relocation of the laboratory while concurrently performing compliant testing. Led the laboratory group through a 10-fold increase in sample testing capacity.Supervised and contributed to the development and ICH validation of several analytical methods required for the evaluation of release rates and stability indicating assays of various active compounds from experimental drug delivery devices. Collaborated on ISO extractable and leachable testing of polymers, and managed polymer characterization strategies including oversight of the development of size-exclusion, light scattering, and mechanical testing procedures.Authored numerous SOPs, test procedures, investigation CAPAs, as well as validation, ICH stability, and technical protocols and reports.Scheduled and managed the metrology function of the analytical laboratory, including the validation of data acquisition software platforms for CFR part 11 compliance.Led a team of analytical scientists in the support of generic product development. Supported two pilot batch studies and one exhibit clinical batch under tight time lines within a newly set-up laboratory.

Responsible for the development, qualification and validation of analytical methods in support of formulation feasibility, preclinical, and early phase clinical research on vaginal drug delivery technology. Managed a proprietary endometriosis treatment project from initial formulation feasibility through the early phase clinical trials. Developed and validated dissolution, UV/Vis, HPLC and GC testing methods for various active compounds and related impurities including a new technique for multi-week dissolutions of trans-mucosal rings for possible consideration as an additional USP apparatus. Utilized cGMP background to set up an analytical laboratory for the testing and release of preclinical and early phase clinical products. Authored method qualification and product stability protocols and reports, as well as laboratory policy and calibration SOP’s. Delegated routine dissolution and HPLC testing of formulations to junior chemists and audited resulting data for GLP/cGMP compliance.

Analytical Services Group Chemist III: December 2000-December 2001: Responsibilities include: the validation of analytical methods employed in the quality control lab, the qualification and transfer of new analytical methods from development to the quality control lab, and the investigation and remediation of analytical method deficiencies. SQLLIMS Project: July 1999-February 2000: Part of a team that performed the transfer of data and specifications from a DOS based STAR*LIMS database to the PE SQL-LIMS database. Performed changes and corrections to the database after launch. Documented changes for regulatory compliance. Developed and performed user training for approximately 100 scientists. Assisted in follow-up training and troubleshooting after launch. Installed laboratory computer stations.Quality Control Chemist I & II: Responsibilities include: identification (IR, UV/Vis and TLC) and quantitative analysis (HPLC, GC and UV/Vis) of bulk and finished product pharmaceuticals.

Assisted in the development and scale-up of the manufacturing process for a PEG based micro-suppository for the treatment of impotence (MUSE®, Medicated Urethral System for Erection).Responsible for research that bridged the commercial manufacturing process with the original IND described clinical manufacturing process and collaborated with engineers on the development of the commercial scale suppository manufacturing equipment. Assisted in the validation of all aspects of the manufacturing procedure including the design and execution of the parameter challenges and performed numerous experiments to assist in the validation of QC/QA procedures. Created manufacturing SOP’s and trained three technicians on the manufacturing procedure. Demonstrated and explained the manufacturing process to FDA investigators during the product’s PAI.