With over 25 years of experience in the pharmaceutical industry, I provide consulting services to analytical laboratories, manufacturing, packaging, quality and compliance. Current and past mandates include: - Provide consultation for the manufacture of validation batches for a product which will enter phase 3 clinical trials. Review of analytical methods, analytical method validation reports, batch records and Out of Specifications (OOS) investigations. Direct interactions with the CDMO. Technology transfer both analytical and manufacturing to CDMO site located in the US. Contribute to Regulatory filings both in Canada and US. - Optimization of a formulation which falls into the 505 (b) (2) category in the US. Review of drug development reports, analytical methods, analytical method validation reports, manufacturing batch and packaging records. Stability data review and analysis. - Transfer of analytical methods within the laboratory with instruments purchased from different manufacturers. Authoring of method validation protocols and reports. - Review of analytical methods and validation reports for a pharmaceutical company. - Provide audit assistance during and after regulatory inspections. Member of USP's Performance Verification Testing Standard Expert Panel until 2025. Speaker at the University of Montreal in the Pharmacy program (drug development - analytical development class). Panelist for the Dissolution Discussion Group (DDG).

Evaluation, optimization and validation of manufacturing processes of injectable drugs in an aseptic environment. Scale up and transfer of batches from external manufacturers to the recently FDA certified manufacturing and packaging facility. Provide required documentation for submissions and fillings with Canadian, US and Japanese Regulatory Agencies. Technology transfers (injectable drugs) both manufacturing and analytical from CDMO sites in Asia and North America to Omega located in Montreal, Canada. API supplier evaluation for supply and cost savings. Author Technical Transfer Assessments (TTA), Critical Processing Parameters Evaluation (CPP) and Validation Plan Protocols and Reports (VPP) documents. Author Change Controls, deviations and investigations when required.

Oversee the daily operations of the calibration and qualification activities in the analytical and formulation laboratories in Research and Development. Author, revise and update SOPs to reflect current industry practices. Author, review and approve laboratory investigations in EtQ related to failing calibration results. Author, review and approve Global Change Controls (GCC) for the qualification of new and existing laboratory and manufacturing equipments.Supervise the work of 3 scientists and one summer intern.Service contract negotiation and management. Manage the budget of the Metrology group.Evaluation and introduction of new calibration procedures based on current industry trends and regulations which improve efficiencies and minimize equipment down time.Evaluation, purchase and qualification of new laboratory equipment.Collaborated in the preferred service provider selection process by evaluating and rating bid proposals.Act as point of contact for metrology during internal and regulatory audits.Establishment and creation of a metrology group for the qualification, calibration, maintenance and repairs of laboratory instruments and manufacturing equipments at J&J Consumer in Fort Washington.Auditing currents and proposed Original Equipment Manufacturers (OEM) in collaboration with the R&D Quality and Compliance group in order to achieve compliance to the approved OEM/vendor master list.Review and approval of quality agreements with OEM.Establishment of a shared HPLC/UPLC preventive maintenance and calibration schedule to improve instrument use and minimize down time.Author, review and approve Computer Software Validation (CSV) related documents. Owner of the Global Change Control for the data integrity initiative for laboratory instruments at the Fort Washington R&D site.Successfully implemented Enhanced Mechanical Qualification (EMQ) in the dissolution laboratory (2nd place finish for a poster at J&J Consumer research day).

Oversee the daily operations of the dissolution laboratory in R&D.Responsibilities include, SOP revision and writing, calibration data review and approval, implementation of a training program for dissolution testing for new hires.Evaluation of new equipment.Interaction with other J&J sites on dissolution related issues.

Counselor for a 2 week period every summer during a hockey camp for kids aged from 5 to 17. On and off the ice counseling of the participants.

Develop and validate dissolution methods for new drug products. Perform solubility studies/profiles on new active pharmaceutical ingredients. Perform intrinsic dissolution studies on new and existing APIs. Develop HPLC, UV methods for the analysis of dissolution samples.Develop and validate dissolution methods using the Fiber Optic technology.Technical report writing.Work in close cooperation with the formulation group.

Plan, organise, direct and control the operation of the Premarin Investigation Team L:aboratory to assure full compliance with corporate policies and governmental regulations. Act as the official Premarin Investigation Team representative during FDA, DEA, BOH and internal corporate inspections. Provide compliance review and approval support for Premarin Investigative Testing.Responsibilities included : Plan, direct, evaluate and control the operation for the Premarin Investigation Team to ensure all required work is performed efficiently, accurately and within required time frames. Assure compliance with legal, regulatory and company policies. Inform Director of Quality Assurance of all potential quality issues.Interact with all levels of management to provide timely technical analytical support for investigation of Out Of Specifications (OOS) test results. Serve as the Subject Matter Expert (SME) on Premarin OOS investigations.Evaluate testing protocols, reports, project schedules and all other analytical requests as well as personnel training on a continuing basis to assure most efficient allocation of resources (manpower, equipment, etc.) to comply with regulations and company schedules.Provide managerial, technical and organizational leadership. Administer personnel policies, practices and procedures. Interview, select, train personnel and provide professional development opportunities.Develop, monitor and report metrics relating to testing, disposition, training, staffing, safety and the budget.

Investigate, complete, track and trend manufacturing discrepancies and resulting commitments within Premarin. Initiate Manufacturing Investigation Reports (MIR)/Laboratory Investigation Reports (LIR) and coordinate the actions required for its resolution. Determine corrective actions and/or commitments and write clear, concise summaries of investigations, product impact assessments, and commitments.Gather and review batch documentation, testing results, training records, calibration records, level I and II policies, testing and manufacturing specifications, validation documents and other technical documents. Work closely with Technical Support and Quality Assurance to ensure that all the investigations are performed according to corporate and site guidelines.Authored over 250 laboratory and manufacturing investigations.

Supervised a team totaling 7 analysts and support staff providing analytical support for stability studies, and release of raw materials and finished products for domestic, American, and International markets.Developed, improved and validated GC, HPLC and dissolution test methods.Served as the primary contact from the Canadian manufacturing site on analytical issues during method/technology transfers from US sites.Provided analytical support for engineering and validation batches.Involved in the recruitment, interview, hiring, and training of students and new employees.Conducted employee performance appraisals, promotions and terminations.

Analytical method development and validation, plus quality control testing (USP, BP) of raw materials, finished products, and stability samples in a strict GMP/GLP environment. Provided analytical support to a compound which was in Phase IIb/III.Development and validation of automated dissolution methods. General SOP, method SOP, and method validation report writing, plus participated in new employee training.Supervision of a summer student working on a special project.Presented a poster at the International Symposium on Laboratory Automation and Robotics (ISLAR) in October 2000. “Evaluation of a bias observed with the Zymark MultiDose dissolution system”