VP of Manufacturing and CMC at Alladapt Immunotherapeutics, Inc.
San Carlos, California
Achaogen
Senior Director of CMC
July 2013 to October 2018
South San Francisco
Stealth-mode biotech startup
VP of Manufacturing and CMC
February 2019 to February 2019
SF Bay Area
Anesiva
Senior Director of Process Development
2006 to 2008
Corgentech Inc
Senior Director of Process Development
2002 to 2006
Alladapt Immunotherapeutics, Inc.
VP of Manufacturing and CMC
Menlo Park, California
MAP Pharmaceuticals
Director of Process Engineering
2009 to March 2013
Lynx Therapeutics
(various positions until) Head of Chemistry
1993 to 2002
Eastman Kodak
Coop Student
1982 to 1988
What company does Jim Kirchner work for?
Jim Kirchner works for Achaogen
What is Jim Kirchner's role at Achaogen?
Jim Kirchner is Senior Director of CMC
What industry does Jim Kirchner work in?
Jim Kirchner works in the Biotechnology industry.
đź“– Summary
Senior Director of CMC @ Achaogen From July 2013 to October 2018 (5 years 4 months) South San FranciscoVP of Manufacturing and CMC @ Stealth-mode biotech startup From February 2019 to February 2019 (1 month) SF Bay AreaSenior Director of Process Development @ Anesiva Directed all activities related to process development and analytical development in the development/ manufacture of two clinical products: a first in man new chemical entity and a new chemical entity in phase 3 development AdleaTM From 2006 to 2008 (2 years) Senior Director of Process Development @ Corgentech Inc Responsible for building the entire internal process development and analytical development groups as well as directing CMO’s for API and drug product configurations. Directed all activities related to the drug product, process development and analytical development including technical oversight of two clinical transcription factor decoy products From 2002 to 2006 (4 years) VP of Manufacturing and CMC @ Alladapt Immunotherapeutics, Inc. Menlo Park, CaliforniaDirector of Process Engineering @ MAP Pharmaceuticals Directed process engineering and phase III development in the outsourced development/ manufacture of two phase III clinical programs and preparation for commercial launch and NDA submission for both drug substance and drug product. • Responsible for the strategic plans and direction of process engineering API to drug filled canister for Levadex® and API to blow fill sealed nebule for UDB• Identified the NDA enabling activities, risk points and risk mitigation strategy on the DHE program and implemented solutions• Lead NDA resubmission as well as primary author on drug substance and drug product sections• Developed the validation plans for multiple CMO’s for API, heat and spray testing vendor• Negotiated 50% price reductions in commercial supply agreement for final drug substance From 2009 to March 2013 (4 years) (various positions until) Head of Chemistry @ Lynx Therapeutics •Built the chemistry group from the ground up and directed a group of nine scientists and a budget of $2 million. The chemistry group provided Lynx with combinatorial DNA micro-particles for its Megaclone technology, oligonucleotides from the nanomole scale to 100’s of umoles as well as protein DNA conjugates. The group was involved in DNA production as well as research and development with oligonucleotides•Collaborated with software, mechanical and electrical engineers, as well as molecular biologists and executive officers of the company, to provide broad-based science and business solutions. •Negotiated contracts with suppliers and collaborators•Led company tours for the investment community and addressed Wall Streets inquiries related to the chemistry of the MPSS and Megaclone technology From 1993 to 2002 (9 years) Coop Student @ Eastman Kodak Worked in the electophotography division in the organic synthesis group synthesizing and characterizing novel electron transport agents and some novel cyano dyes for the evaluation in the electorophotography program.•Performed multi step synthesis of novel chemical compounds•Purified novel chemical compounds by recrystallization, flash chromatography, and HPLC.•Submitted novel molecules for product testing in the electrophotography group From 1982 to 1988 (6 years)
Extraversion (E), Intuition (N), Feeling (F), Judging (J)
4 year(s), 4 month(s)
Unlikely
Likely
There's 93% chance that Jim Kirchner is seeking for new opportunities
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