John S Dickson Email & Phone Number

United States

I manage the Quality Control Group, integrated by twelve qualified analysts and two administrative assistants. Responsible for supporting manufacturing and formulation departments. Utilizing high-quality standards approaches to maintain compliance and productivity. Key responsibilities include: • Responsible for establishing, maintaining, and enforcing laboratory quality systems, standard procedures, and company policies to ensure compliance with product-established specifications.• Plans for future lab requirements, including procedural requirements, capital planning, personnel recruitment planning, compliance requirements, efficiency and optimization objectives, and anticipated changes needed to reflect future demand.• Responsible for providing expertise and guidance to the laboratory team in interpreting company procedures, policies, and federal agency regulations to guarantee compliance. • I manage all aspects of the laboratory quality system, including ongoing data analysis of raw material, finished products, stability data trends, data integrity, investigation of out-of-specification results, deviations, and CAPA implementation. In addition, I support the auditory of GxP external vendors and respond to internal and external audit observations from the company's quality assurance department and clients.• Responsible for appropriate staffing and developing the QC organization to meet business needs and succession plans.• Develop and control laboratory budget, organizational structure, and business requirements to accommodate budget and ensure goals are met.• Responsible for establishing and ensuring compliance with cGMPs, analyst training matrix, good laboratory practices, and equipment qualification (IQ/OQ/PQ, calibration, and maintenance).• Responsible for working with the product development group and clients to establish specifications.

Chestnut Ridge, Ny, Us

I managed the Analytical Research and Development Group, integrated by 30 qualified scientists and two administrative assistants, supporting R&D, Formulation, and Quality control units, utilizing quality system-based approaches to maintain productivity with high-quality standards. Key responsibilities include:• Identify critical points that could affect the progress of the project. Then, propose solutions and follow up with the formulation, quality control, and quality assurance teams. • Review the drug substance (DS) Master File to determine compliance with current ICH guidelines and FDA regulations. Identified improvement areas and any potential deficiencies in the specifications, analytical methods, and validations. Communicate with the API vendor, resolve the deficiencies, and update procedures as required.• Actively managed stability program for diverse projects. Prepare trend analysis reports to determine potential challenges of the new formulations. • Coordinate the method transfer of validated and verified analytical methods to the quality control department.• Conducted investigation of out-of-specification (OOS), out-of-trend, deviations, and alert limit results using trackwise system.• Ensure the Analytical Services laboratory complies with new and existing company standard procedures.• Supervised sample management group (controlled and non-controlled substances)• Prepared and submitted to the regulatory affairs department all method verifications and validations report and qualification of reference material used during the drug product analysis in preparation for project submission to the FDA. • I coordinated the reference and in-house standard qualification programs according to ICH and USP guidelines.• I provided expert leadership to a group of scientists during daily method validation and routine testing.

Chestnut Ridge, Ny, Us

• Wrote, and reviewed verification or/and validation of the analytical method intended for the analysis of raw material and finished product.• Provided expert leadership to group of scientists during daily method validation and routine testing Fulfilled complex laboratory functions, which included sampling, testing of physical and chemical components; analysis of raw materials, active pharmaceutical ingredients, in process, finished, and stability products.

• I was responsible for developing and validating analytical procedures for analyzing complex raw materials mixtures and finished products. Implementation of a quality system according to CGMP and FDA guidelines.

Miramar, Fl, Us

• I Supported the early development of Phase I and phase II drug products by leading a team of qualified scientists responsible for optimizing and validating complex analytical methods for a wide variety of drug substances and drug products. • I was responsible for designing and validating analytical procedures to evaluate traces of API in pharmaceutical equipment (cleaning verification). • I was responsible for coordinating the routine testing of release samples. As well as coordinating the stability program, scheduled the testing of stability samples, and provided the analytical reports to support the regulatory filings.

Miramar, Fl, Us

• I Supported the formulation group, quality control department, and R&D departments by performing analytical testing on drug product prototypes, solid doses, liquids, injectable and semi-solids forms. I executed method validations and verification for raw materials, intermediate, and finished products. In addition, I supported investigations of out-of-specification results (OOS) reviewed analytical data according to product specifications and company Standard Operating Procedures. • Performed maintenance and troubleshooting of analytical instrumentation such as HPLC, GC, Particle Size Analyzer, Auto titrator, FTIR, UV-Vis, and BIO-DIS

• I Performed analytical testing of raw materials, intermediates, finished products, and stability samples according to their specification.• I assisted management in Out of Specification and out of trend investigations following the company standard operating procedures and the CGMP guidelines.• I performed maintenance and troubleshooting of the Analytical instrumentation of the Quality Control Department.• I assisted in the method transfer and validation of analytical procedures.

Bs, Pharmaceutical Chemistry

Master'S Degree, Biomedical/Medical Engineering