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John Feeney, M.S. personal email
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Skilled, versatile pharmaceutical professional with over 25 years in Brand and Generic companies involving ANDA, NDA and 505(b)(2) filings. Core competencies include:* Proven results in creating GMP compliant and efficient analytical laboratories (R&D and QC)*Strong positive compliance record with FDA and DEA.*Extensive experience with CMC, OOS Investigations and CAPA.*Strong experience in Technical Writing*Quality System, SOP and system design for FDA-GMP-ICH compliance and efficiency*Development and validation of useful, transferable analytical test methods for QC. *Rapid transfer of analytical test methods to commercial laboratories.*Strong staff development through training and mentoring. *Able to direct and motivate people from diverse backgrounds. *Adept at managing multiple priorities and resources to meet challenges of complex projects.
Kells Alliance Consulting Llc - Available, Pt, Remote Or On Site.
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PrincipalKells Alliance Consulting Llc - Available, Pt, Remote Or On Site.Danbury, Ct, Us
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Founding Board MemberThe Saints And Scholars Foundation May 2020 - Present
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PrincipalKells Alliance Consulting Llc - Available, Pt, Remote Or On Site. Jan 2010 - PresentCommitted 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
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Adjucnt Professor Of ChemistryFairfield University 2013 - Sep 2017
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Serving As An Independent ConsultantLachman Consultants Oct 2010 - Jul 2012Provided 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.
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Manager, Qc / AcVion Pharmaceutical, Inc Sep 2007 - Dec 2009Supervise 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.
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Joyce'S HusbandSt Gregory The Great School 2006 - 2007Oxford, Gb -
Assoc. Director, R&D OperationsWatson Laboratories Inc., Carmel, Ny 1999 - 2006Directed 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.
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Group Leader, Ar&DSchein Pharmaceutical, Inc., Carmel, Ny Jan 1993 - 1999Supervision 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.
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ChemistCarey Industry Inc., Danbury, Ny Jan 1989 - Jan 1993Responibilites for method development and validation of HPLC and spectrophotometric assays used for the purity determination of various organic dyes. .
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Scientist Iii, Ar&DBoehringer Ingelheim Pharmaceuticals, Ridgefield, Ct Jan 1981 - Jan 1988Carried 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.
John Feeney, M.S. Skills
John Feeney, M.S. Education Details
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Rutgers UniversityOrganic And Organometallic Chemistry -
York College Cuny. ChemistryChemistry
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Daltai Na Gaeilge
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Daltai Na Gaeilge
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Irish Arts Center
Frequently Asked Questions about John Feeney, M.S.
What company does John Feeney, M.S. work for?
John Feeney, M.S. works for Kells Alliance Consulting Llc - Available, Pt, Remote Or On Site.
What is John Feeney, M.S.'s role at the current company?
John Feeney, M.S.'s current role is Principal.
What is John Feeney, M.S.'s email address?
John Feeney, M.S.'s email address is jf****@****all.com
What is John Feeney, M.S.'s direct phone number?
John Feeney, M.S.'s direct phone number is +120349*****
What schools did John Feeney, M.S. attend?
John Feeney, M.S. attended Rutgers University, York College Cuny. Chemistry, Daltai Na Gaeilge, Daltai Na Gaeilge, Irish Arts Center.
What are some of John Feeney, M.S.'s interests?
John Feeney, M.S. has interest in An Irish Language School, Blog At Www, Irishgaeliccircle, Com, Blogspot.
What skills is John Feeney, M.S. known for?
John Feeney, M.S. has skills like Validation, Fda, Gmp, Pharmaceutical Industry, Glp, Analytical Chemistry, Sop, Hplc, Regulatory Affairs, Capa, Quality System, R&d.
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