Nicholas Vincent Email & Phone Number

Bedford, Ma, Us

Bedford, Ma, Us

Updating and Revising MPR's and SOP's; Collaborating with multiple departments to ensure that all current changes are incorporated into the latest revisions of the document; Working with SME's to determine the most efficient and practical process are included during the documentation updates; Assisting with deviations and TCR's to ensure closure within the appropriate deadlines

Chicago, Us

Updating and Revising MPR's and SOP's; Collaborating with multiple departments to ensure that all current changes are incorporated into the latest revisions of the document; Working with SME's to determine the most efficient and practical process are included during the documentation updates; Assisting with deviations and TCR's to ensure closure within the appropriate deadlines

Creating, Updating, and Revising MP's, QP's, TP's and SP's as requested to complete projects in a timely manner. Transfer of Protocols and Reports into pre-established templates. On-boarding of new employees. Maintaining training criteria for all assigned employees with RCMT above 90% consistency. Maintaining training database and performing metrics to track compliance among consultants.

Generating SOP's and batch records using P&ID's and other resources. Revise existing documentation to align with company policies, as well as production standards.

Performed small scale ink manufacturing in a biosafety cabinet and laminar flow hood to ensure an air free environment. Large scale ink manufacturing using ROSS mixer and vacuum systems.

Performed commercial API manufacturing and chemical development. Fully trained in Potent Compound Handling, Aseptic filling, and cGMP. Daily duties required column chromatography, filtration, solution/buffer/media preparation.

Basel, Ch

Performed Protein Purification using HPLC Column Chromatography and UF/DF. Used living cells for the production of pharmaceutical products as part of a CMO. Fully trained in aseptic technique and cGMP.

North Chicago, Illinois, Us

Monitoring of Class 100,000, 10,000, and 100 areas. Plate reading to determine action and alert levels are within range.

Kalamazoo, Mi, Us

Matrix manufacturing performing all duties associated with production, including CIP/SIP, buffer preparation, lyophilization, and aseptic fill. Cross trained in QA Documentation Control performng change controls, deviations, CAPA investigations, batch record and logbook review, and tracking and trending of performance metrics. Hands on training of new employees. Revising and initiating new SOP's and documentation.