John Feeney, M.S. Email & Phone Number

Danbury, Ct, Us

Committed to creating the marriage of science and compliance that is vital for the efficient development of FDA approvable products. Specializing in: - Creating efficient and compliant Analytical Laboratory Operations- Design and Implementation of SOPs Documentation and Quality Systems- Project Management- Analytical Method Development and Validation - Troubleshooting Test Methods and Processes- Staff Development- CMC, OOS and CAPA- Consent Decrees

Provided services as an independent consultant to several of their clients:- Performed several Laboratory and Quality System Audits for GMP compliance involving Consent Decrees.- Evaluated OOS Laboratory Investigations and subsequent CAPA's for GMP compliance.- Evaluated Annual Product reviews by Regulatory Affairs for compliant submission of changes.- Evaluated Method Validation reports for GMP / ICH compliance.

Supervise 1-2 chemists in providing analytical testing support for NDA filing and shipment of clinical supplies, drug substances and drug products. Created or revised SOPs to ensure an FDA/ICH compliant operation of the Quality Control / Analytical Chemistry Laboratory.

Oxford, Gb

Directed a group of up to 13 chemists and project leaders in providing analytical testing support for ANDA submissions. This support included development and validation of analytical test methods, process improvements and all release and stability testing with related documentation for FDA submissions. Provided analytical input for FDA Pre-Approval Inspections and Deficiency Letters. Accomplishments achieved:Successful integration of Schein and Watson Systems and SOP's for business efficient and compliant laboratory operations.Strong compliance record with FDA.Validation and testing support for Metformin, Methylphenidate ER, Famotidine, Nizatidine, Cyclobenzaprine and Oxycodone - APAP submissions.Improved efficiency of the analytical method transfer process during commercialization resulting in approximately a 50% reduction in time spent.Staff training and mentoring produced 4 new Project Leaders.Transferred the Analytical laboratory to new facilities while maintaining a vigorous and compliant testing schedule.

Supervision of three chemists for supporting the following: responsible for development and validation of analytical test methods (HPLC, TLC, GC, UV, Dissolution, Titrimetry) for raw materials, Active Pharmaceutical Ingredients, Finished Products in support of release and stability testing for ANDA filings. Performed method and instrument troubleshooting. Process improvements. Organized AR&D product files for FDA inspections and responsible for communications among management and direct reports during inspections. Represented AR&D at cross-functional project teams. Prepared test methods, SOP's and validation reports. Acquired a working knowledge of Personal Sign Language to facilitate communication with staff.

Responibilites for method development and validation of HPLC and spectrophotometric assays used for the purity determination of various organic dyes. .

Carried out method development and validation of assays and procedures (HPLC, TLC, UV, titrimetric, etc.) for release of active ingredients, reference standards, formulations, stability studies and impurity assays. Responsible for active ingredients specs and review of procedures developed by other scientists. Represented department on a Compound Development Team. Designed written SOP's to meet GLP and GMP regulations. Trained and assisted junior staff in methods development, analyses and troubleshooting. Promoted from Scientist II to Scientist III.

M. S., Organic And Organometallic Chemistry

B.S, Chemistry

Education record

Education record

Education record