Matthew Jacobs Email & Phone Number

10 years of sterile injectable manufacturing with a strong emphasis on compounding. Started my career at a small contract manufacturing company in Lexington KY specializing in clinical and commercial production, here I learned the bulk of my skills;cGMP, Compounding, Filtration, Sampling, Isolator Compounding, Isolator Filling and all the associated cleaning/setups/HPV, VHP decontamination cycles. Sterilizing and sanitization of autoclave loads, Vial washing, operation and unloading of Depyrogenation ovens, inspection, packaging, and all batch reconciliation activities. Strong understanding of cGMPs and FDA regulatory requirements. I've worked through many audits, with regulatory inspectors as well as clients. Investigative and QA personnel over the years have shown appreciation for my perspective on matters such as process deviations, or process improvements.Mid-Career I focused exclusively on formulation/compounding which included all the associated cleaning and logistics activities. Batch sizes ranged anywhere from 150L-1800L, with large scale additions of raw materials and active ingredients. Gravimetric and volumetric batches, with experience in larger quantities of manufactured Controlled substances. Late-Career I transitioned into a 503b manufacturer. Specializing in the repackaging and repurposing dosages of specific drug. Aseptically transferring finished product into syringes ; Hand fills and more automated with Turbo Fill machine. Filling of Vials and Droptainers. Some topical products compounded and filled into containers. Sterile and Non Sterile compounding which includes filtration. Because I have worked in three considerably different sectors of the pharmaceutical industry it has helped me develop a great deal of understanding of what it means to be GMP and how to execute and carry out processes effectively and safely. All the experience and perspective I've gained over the years have been instrumental with my success and have helped tremendously when learning new unfamiliar processes or adapting to new careers.

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  Boyle County High School

  High School Diploma