Michael Katzman Email & Phone Number

Southampton, Pa, Us

Southampton, Pa, Us

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Blue Bell, Pa, Us

Validation Specialist on assignment at GSK in CollegeVille, PA | Aug 2022 - Oct 2022

King Of Prussia, Pa, Us

On assignment at Merck & Co. West Point, PA▪Participated in and led cross-functional teams supporting computer system validation activities associated with new or upgraded instruments or software packages▪ Served as a business area representative on all validation projects and communicated timelines, issues, and expectations with all appropriate parties▪ Drafted, executed, and approved validation documentation applying to a wide variety of lab-based instruments▪ Participated in drafting or updating standard operating procedures (SOPs) to ensure all computer systemvalidation requirements are met and applied

Red Bank, New Jersey, Us

On assignment at Merck & Co. West Point, PA•Followed in house protocols for GMP stability, uniformity, and dissolution testing of formulated pharmaceutical drug products utilizing HPLC methodology. •Supported formal stability study execution through routine testing, data analysis and investigation of OOS/OOT results in collaboration with project chemists.•Performed instrument/equipment verification and calibration.•Commonly handled multiple concurrent laboratory tasks with attention to detail and accuracy, and quickly learned new technologies and methodologies to meet tight deadlines and comply with regulations. •Performed second scientist review of GMP data documented and performed in electronic notebooks.

Somerset, Nj, Us

▪ Provides analytical support to Operations group, with emphasis on in-process particle size analysis, ID testing,controlled substance testing, and cleaning verification.▪ Performs analytical testing on external sample submissions in accordance with client test methods, Catalent test methods, and compendial (USP, EP, JP, etc.) methods.▪ Prepares written test reports summarizing all analytical results derived in support of Catalent Operations orexternal sample submissions▪ Conducts peer review of raw data/documentation▪ Documents all testing, deviations, and investigations per cGMP and Catalent guidelines.

South Plainfield, Nj, Us

▪ Followed in-house methodologies and United States Pharmacopeia (USP) guidelines to test raw materials and finished products including solid oral doses and LCO (liquids, ointments and creams) products.▪ Performed analytical and physical testing of raw material excipients and active pharmaceutical ingredients (API). ▪ Operated, calibrated, and troubleshot issues with Malvern MasterSizer 2000/3000 and Micromeritics ASAP2020.▪ Developed and validated physical testing methods for Malvern Mastersizer 3000.▪ Maintained accurate records of test procedures using LIMS software.▪ Contacted equipment manufacturers to schedule repairs and troubleshoot equipment.

Philadelphia, Pa, Us

▪ Worked under cGMP/GLP regulated lab environment following in-house methodologies.▪ Performed routine wet chemical and instrumental analysis on pharmaceutical oral doses within the framework of cGMP/cGLP guidelines.▪ Maintained accurate laboratory records including a neat and detailed notebook by FDA guidelines.▪ Assisted in managing the laboratory budget by preventing excessive ordering of reagents and reducing waste from expired, unused reagents.▪ Ensured laboratory documentation was FDA compliant within GMP/GLP environment in preparation for FDA annual audits.