Dennis Clemons Cpht Email & Phone Number

Baltimore, Md, Us

Princeton , Nj, Us

Princeton , Nj, Us

• Following all applicable regulatory requirements, cGMP guidelines, and industryguidance documents as required by the job function• Reviewing data from raw material, in-process, and product release (API, drug substance, and drug product) conducted at multiple CMO sites• Serving as the point of contact for communication be with quality departments at CMOsites• Serving on departmental and cross-functional project teams• Providing QA review and approval for change controls, deviations, and laboratoryinvestigations, as needed• Providing data collected from data review to drive risk-based process improvementprojects within Quality• Ensuring all work is performed and documented according to approved standardoperating procedures, in general compliance with cGMPs and in a timely mannerconsistent with agreed upon schedules• Regularly meeting with QA management team in the development of best practicestandards, KPIs, identification of training needs, and optimization of resource utilization• Ensuring compliance with all compendia and internal requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia, as applicable)• Assisting with routine CMO/CLO audits• Performing other duties related to the position when required by management

Somerset, Nj, Us

• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing.• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practices• Review and dispositions executed batch records and supporting documentation for completeness, accuracy and compliance• Acts as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.• Acts as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.• Performs Acceptable Quality Limit (AQL) visual inspection of drug product• Write, revise and approve GMP documentation.• Works cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient manner• Participates in site and corporate quality and process improvement initiatives.• Represents QA on team projects.

Franklin Lakes, New Jersey, Us

• Operate and maintain laboratory equipment/instrument in a cGMP-compliant manner.• Coordinates work activities with Planning, Engineering, Quality, R&D, and other functional areas to meet the required schedules, inventories, quality standards, and customer needs.• Coordinated all manufacturing activities across all functions/shifts.• Performs all duties in accordance with ID/AST Plant Operating Procedures and all applicable BDDS Quality Procedures.• Responsible for supporting the manufacturing and assembling clinical and commercial products.• Assisted with in-process testing to ensure batches meet specifications.• Responsible for supporting the validating processes for equipment that is directly related to filtration, cleaning and sterilization. Responsible for the removal and disposal of waste chemicals, solvents and acids.• Produced solutions, powders, and liquids necessary for batches to meet specifications.• Performed serial dilutions on antimicrobic powder.• Generated and maintained inventory of in-house buffers and stock solutions used to produce clinical and commercial products.• Participated monthly inspection of the laboratory to ensure compliance.• Provided training support for on-boarding and/or new procedures.• Completed Panels in the PPMS system and Preformed the initial review of the Batch History Records (BHR) in SAP and PPMS, then submitted to supervisory to be TECO’D.• Assisted in entering and reviewing the Good Issues Item for the panels in SAP to be attached to the Batch History Records (BHR) for final review by supervisory.

Brentford, Middlesex, Gb

• Operated and maintained QC laboratory equipment/instrument in a cGMP-compliant manner.• Coordinated routine in-process biopharmaceutical material, bulk biopharmaceutical ingredients, finished biopharmaceutical and stability sample testing with testing lab.• Conducted and documented routine compendia, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per standard operating procedures.• Completed appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks• Participated in out of speciation investigations and deviations.• Participated in method development, transfer, and validation.• Developed and revised laboratory SOPs• Performed pH, Appearance, Osmolality, Survivable Particulate Matter, and other compendia methods.• Participated in monthly inspections of the laboratory to ensure compliance with cGMP regulations.• Reviewed and approved testing results within SAP.• Supported Quality Assurance (QA) with GMP batch release.• Created Certificate of Analysis GMP batches.

Brentford, Middlesex, Gb

• Operated and maintained QC laboratory equipment/instrument in a cGMP-compliant manner.• Coordinated routine in-process biopharmaceutical material, bulk biopharmaceutical ingredients, finished biopharmaceutical and stability sample testing with testing lab.• Conducted and documented data for routine compendia, chemistry, immunology and molecular biology analytical testing for in-process, release and stability samples per SOP.• Advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.• Participated in out of speciation investigations and deviations.• Participated in method development, transfer, and validation.• Served as stability point of contact for CTL and CMO clients.• Performed data mining and trend analysis for stability test results using JMP.• Creating and revising stability studies, protocols, calendars, and data table for all lots designated for stability.• Reviewed and approved stability testing data within QLIMS.• Submitted annually stability data tables and reports to the FDA and other regulatory agencies to support production of our Bulk Drug Substances.• Help assist with monthly self-inspection of the laboratory to ensure compliance with cGMP regulations.

Woonsocket, Ri, Us

Woonsocket, Ri, Us

Towson, Md, Us

Bachelor Of Science - Bs, Molecular Biology, Biochemistry And Bioinformatics

High School Diploma