John Werner Email & Phone Number

Skiatook, Ok

Consultant on a non-exclusive basis to the pharmaceutical and chemical industries in these areas:• Technical leadership of process design, development, optimization, validation and regulatory filing for new small-molecule APIs through effective cross-functional interactions with CMC team, CROs & CMOs• Design and technical leadership of process development & optimization studies using Quality by Design (QbD) principles to support late-phase cGMP campaigns (registration stability and validation lots). Activities include: 1) manufacturability Improvements, 2) identification of drug substance Critical Quality Attributes (CQAs), 3) control strategies for GTIs, impurities, metals and solvents, 4) control strategies for drug substance physical properties and crystal form and 5) process parameter risk and criticality assessment (FMEA) and critical process parameter identification.• Technical transfer of chemical process steps to global CMOs for cGMP or non-GMP manufacturing. Activities include: request for proposals, vendor selection, campaign oversight, technical documentation review.• Efficient design of ‘fit-for-purpose’ synthetic routes for all phases of development - Med Chem platforms/leads, impurities, early-phase cGMP and late-phase cGMP/commercialization. Also recommendations for application of biocatalysis and process analytical technology (PAT).• Searching of chemical and patent literature to support route design & development and intellectual property protection. SciFinder expertise in keyword, substructure, reaction and patent searching.• Authorship of regulatory documents for new small-molecule drug substances (APIs) in the US and Europe; such as: IND, MAA, registered starting material proposals, Common Technical Document (CTD) for NDA.• Pharmaceutical due diligence for partner or compound acquisition/selection

Indianapolis, In

• Scientific Team Leadership of 20 cross-functional teams, consisting of 4-20 scientists, supporting the drug substance development for 14 clinical compounds and 6 pre-clinical projects. • Lead Process Research Chemist for the phase-appropriate development of efficient, scalable, synthetic routes (5 to 14 steps) for more than 25 drug substance targets, ranging from early-phase route selection through late-phase optimization and process validation. The targets included: heterocycles, chiral acyclic and bicyclic amines, nucleoside and steroid analogs, and semi-synthetic macrolides. • Successful Technical Transfer & Safe Scale-Up of numerous chemical processes to both internal and CMO manufacturing sites; including 54 cGMP and 89 non-GMP process steps ranging in scale from 1 – 2000 kg. The processes employed a wide variety of chemistry, including: metal-catalyzed cross-coupling, alkylations, hydrogenations, acylations, esterifications, cyclocondensations, biocatalytic processes, ester/amide hydrolysis, reductive aminations, arene reductions, ozonolysis, resolutions, SNAr, SN2, catalytic hydrogenations, selective ketone reductions, etc. • Technical Project Management to ensure multi-million-dollar campaigns are successfully and safely completed on-time and on-budget at select Contract Manufacturing Organizations in the US, Europe & Asia. Responsibilities include: authorship of Requests for Proposals to solicit quotes, vendor selection, joint work plan preparation, technical leadership of pre-campaign research at CMOs, campaign technical support and documentation oversight.• Authorship of Regulatory Documents; including the drug substance process chemistry section of a Common Technical Document (CTD) to support final regulatory submission and the briefing documents to support designation of two compounds as drug substance starting materials in both the US (FDA) and EU (CHMP).

Richmond, Ca

Discovery Research Chemist involved in the search for novel cyclohexanedione oxime herbicides with improved crop selectivity and pre-emergent activity to support Chevron’s agricultural chemicals division.

Indianapolis, In

Discovered and developed a new 7-step synthesis of trans-3,4-dimethyl-4-(3-hydroxyphenyl)piperidine by employing a diastereoselective alkylation of a metalloenamine formed by deprotonation of a cyclic allylic amine, which was prepared via a regiospecific cis-themal elimination of a chiral tertiary carbonate. Eliminated 1 step, increased overall yield from 1.6% to 14%, successfully scaled to 50 kg.

Pittsburg, Ca

• Developed processes for the selective chlorination and fluorination of halogenated pyridines that provided access to key intermediates for use in the manufacture of herbicides and resulted in 6 US patents. • Left Dow Chemical to attend graduate school at Stanford University.

Ph. D., Organic Chemistry

Bachelor Of Science (B.S.), With Highest Honors, Organic Chemistry

Associate Of Arts (A.A.), Chemistry