Technology Transfer Personal Care

John M. Gruber, PhD

408-***-****, ***********@*****.***

Career Highlights

• Excellent track record of effective project leadership in chemical/drug substance process research and development.

• Single-handedly created new technology which fueled two successful IPOs.

• Broad experience with reaction scale-up, technology transfer and validation activities.

• Strong track record of successfully managing projects at CROs/CDMOs.

• Worked effectively with analytical and QA/QC to ensure drug quality.

• Invented and developed several innovative green chemical manufacturing processes.

• Demonstrated world-class expertise in all aspects of Catalysis including bio-catalysis.

• Extensive experience with small molecule CMC development. Led teams in the cGMP manufacture of organic chemicals. Several of these cGMP processes are in current production. Broad working knowledge of current ICH, GMP guidelines and chemical engineering. Authored relevant sections of CMC regulatory filings and patents.

• Trained in synthetic organic chemistry and highly experienced in discovery (medicinal) chemistry. Known for having exceptional laboratory skills. Expertise in all aspects of laboratory safety

• Strong mentoring and supervisory skills. Excellent problem-solving skills.

• Experienced with travel to CRO/CDMO sites.

Professional Experience

Scientific Director, Volochem Inc., West Sacramento, CA 2021 to 8/2023 Provide scientific direction to a medicinal chemistry research CRO. Synthesize difficult to make drug candidates. Serve as expert in process optimization, scale-up and manufacturing. Independent Consultant 2017 to 2021

Provided research and scale-up advice to several emerging companies. One client (Arcturus Therapeutics) engaged my services (2021) for GMP process development and validation. Served as a documentation expert

(document review, editing; analytical protocols, analytical methods and MBRs). Chemistry Consultant, REG Life Sciences, SSF, CA 2011-2012(LS9, Inc.), 10/2014-2/2017 Biofuel and renewable chemicals development. Reported to VP of R&D (Stephen del Cardayre). Helped create a portfolio of products based on the company’s fatty acid/ester and alcohol fermentation technology. Identified a major product opportunity. Prepared representative samples in the laboratory for customer evaluation. Examples included various wax esters, isopropyl esters (personal care products), mono-glycerides (emulsifiers for food and personal care products), and diesters (lubricants). Extensive knowledge of the chemistry and transformations of fatty acid/esters.

Chemistry Technical Principal, AMPAC Fine Chemicals, Rancho Cordova CA 2008-2009 Scientific advisor to the president of the company (Aslam Malik). Identified new business opportunities. Identified a project, $15M in revenue Evaluated new cost-effective manufacturing process technologies. Senior Scientist, Codexis Inc., Redwood City, CA 2002-2008 Directed teams that were responsible for the design, development and scale-up of processes using novel enzyme catalysts. These efforts formed the basis of the company (7 patents). Served as technical leader for multi-disciplinary molecular evolution (chemistry, mol. biology, bioinformatics, HTP bioassay, fermentation and enzyme isolation) and tech transfer teams. Invented several efficient enzyme catalyzed processes for the manufacture of pharmaceutical intermediates. Optimized and demonstrated at 20L scale without additional laboratory help. Designed and developed several cost-effective asymmetric transfer-hydrogenations of ketones using novel biocatalysts for the manufacture of both innovator and generic drugs. Developed and implemented at commercial scale, a novel process for a Lipitor intermediate employing three bio-catalytic steps in concert with a partner company. Received a Presidential Green Chemistry Challenge Award in 2006 for the Lipitor process. This process currently (as of 2008) provides over $15M in annual revenue. Independent Consultant 2000-2002

Provided process development expertise to emerging companies. Employed by 4 pharmaceutical clients for evaluating and optimizing chemical processes.

Managed technology transfer activities and performed manufacturing oversight. Managed production timelines to conform to clinical trial needs.

Successfully guided the development and scale-up of three drug candidates (APIs) at three contract manufacturers (CMOs).

As part of an IND filing team, wrote chemistry sections of IND filings. Optimized a two-step process for an expensive drug intermediate, tripling the yield of the process. Research Fellow, Catalytica Pharmaceuticals, Mountain View, CA 1992-2000 Technical advisor to the VP of R&D.

Created IP and successfully managed manufacturing projects. These achievements led to the company becoming a leading CMO/CRO. Company ultimately sold for $800M. Responsible for the company’s manufacturing support and technology transfer activities. Managed special projects, one of these, saved a major customer (GSK) over $40M. Senior Research Scientist, Catalytica Fine Chemicals 1992 – 1999 Responsible for the design and development of novel chemical processes involving catalysis. Considerable experience with commercial scale hydrogenation.

Managed projects and scientists from initial hands-on lab work through piloting to commercial scale production. Directed a group of three PhD scientists. Extensive experience with small-molecule pilot scale (400L) processing. Managed multi-disciplinary piloting and manufacturing start-up teams (engineering, production, analytical, material control, EH&S).

Prepared technical documentation (master batch records, in-process controls, analytical specifications). Trained plant operators in the operation of the chemical processes. Provided guidance and oversight to analytical methods development.

Designed and developed several novel processes for the production of pharmaceutical intermediates. Excellent synthetic and analytical skills.

Primary inventor on 5 patents.

Successful process development and scale-up efforts on Pfizer projects led to the signing of a $15M research contract/investment by Pfizer.

Education

PhD, Chemistry: University of Idaho

B.S., Chemistry: University of California, Berkeley References

John H. Grate, PhD; (formerly) Sr VP & CSO, Codexis Inc., 650-***-**** Robert Seemayer, PhD, Executive Director, **************@******.*** Professor Roger A. Sheldon; (formerly) Delft University of Technology, +31-157****** Richard D. Beatty; (formerly) VP of Project Management, Ampac Fine Chemicals, 916-***-**** Patents and Publications

A complete list of patents and publications will be provided upon request.

Contact this candidate