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

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

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.

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.

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.

Woonsocket, RI, US

Woonsocket, RI, US

Towson, MD, US

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

High School Diploma