Mark B. Email & Phone Number

Philadelphia, PA, US

San Diego, California, US

• Discovered, developed and implemented safe and efficient processes for all client HP-API (High Potency-Active Pharmaceutical Ingredient) GMP manufacturing campaigns.
• Identified opportunities for improvement or optimization in current processes and implement viable solutions
• Investigated route modifications to limit cytotoxicity until the final step to reduce the cost of goods and increasing overall safety.
• Exhibited detailed record-keeping, data analysis and chain of custody controls required in successful implementation of GMP.
• Anticipated issues during campaign preparation to minimize deviations.
• Created, modified and updated Master Batch Records (MBR), Specifications, Standard Operating Procedures (SOP), Specific Work Instructions (SWI)

The Woodlands, TX, US

• Developed and implemented processes for all twelve of Lexicon’s clinical candidates prior to preclinical nomination.
• Modified, improved and analyzed kilolab chemistry to ensure future successful scale-up at CMOs.
• Focused on “fit for purpose” chemistry to allow efficient use of all resources including time and equipment.
• Equipped and was solely responsible for Lexicon’s kilo lab.
• Planned, managed, organized, scheduled and ran all large scale chemistry up to 50L scale.
• Provided early stage development support through impurity identification, minimization and reference standard preparation of all potential impurities for API, including reducing PGIs.

Lawrence Township, NJ, US

• Supplied key intermediates and potential new drug substances to support 12 pre-clinical candidate evaluations and numerous exploratory and full phase programs.
• Synthesized large amounts of core structures and linkers in support of early phase combinatorial chemistry programs for use as templates for compound libraries.
• Collaborated with early phase program groups to make competitor’s compounds for the support of bench marking and bioassay developments.
• Introduced 12L and 20L reactor technologies to enable more efficient large scale synthesis.
• Co-authored 24 external scientific publications, one patent application, 3 external posters and numerous internal posters and presentations.
• Supervised summer intern students both technically and administratively.

Lawrence Township, NJ, US

• Developed and optimized processes to be run in the pilot facility prior to introduction to full-scale manufacturing.
• Interacted with engineers to design or adapt processes to foresee and minimize potential problems associated with large-scale operations.
• Involved with the isolation of desired products and intermediates from biological fermentations.
• Prepared 500g batch of drug substance following GMP conditions for potential licensing deal.

Ms, Organic Chemistry

Bs, Chemistry