STANLEY A. LANG, PH.D.

** ******** **.

Piscataway, NJ 08854

Phone: 732-***-****; Cell: 714-***-****

Email: ac4l7k@r.postjobfree.com

HIGHLIGHTS AND QUALIFICATIONS

More than 35 years in the Bio/Pharma Industry

Extensive experience in Pharma R&D, Process Chemistry, CMC and Regulatory Submissions, Manufacturing, Business Development and Project Management

More than 150 Patents & Publications

Special skills include: BD support, process development, radiosynthesis, in IP to IND activities including CMC and Regulatory Support, Operational Excellence Lean6Sigma tools

Carry out projects in GMP (CMC and Regulatory support) and non-GMP labs and R&D labs

Very skilled at Tech Transfer – lead a number of such transfers, including international collaborations.

WORK EXPERIENCE

Project Executive, University of Akron Research Foundation

Consultant – OMM Scientific on pre-IND Activities

CSO - BNOAT Oncology for Drug Development

Marketing & Business Development Consultant – Shanghai ChemPartner

ARCHANGLES and North Coast Angel Fund Facilitator

Treasurer International Society of Heterocyclic Chemistry

Consultant to the Cystic Fibrosis Foundation Therapeutics

Lean6Sigma Management Training – Operational Excellence Black Belt

ADDITIONAL PROFESSIONAL EMPLOYMENT HISTORY:

Projective Executive – University of Akron Research Foundation June 2010 - present

Support Development Activities on an optical devise, polymer coatings and Silvamist™, including CMS and Regulatory responsibilities

Work with start-ups within the University

Akron Medvision, Nebusil, Devices

ARCH-Angles and NCFA Facilitator June 2010 present

Due Diligence on Funding Projects

CSO - BNOAT Oncology for Drug Development May 2010 – July 2013

Virtual Company: Coordinate pre-IND activities, manufacturing, pre-IND FDA Meeting, CMC and Regulatory responsibilities, interact with appropriate CROs, vendor selections, deal with specialized consulting firms, interact with investors

Marketing & Business Development Consultant for Shanghai ChemPartner March 2010 present

Business Development

Client Visits

Generate Contact Lists

Responsible for US based non-Pharma Business development

Consultant for OMM Scientific July 2010 present

RICERCA BIOSCIENCES, LLC, Concord, OH

Director Process Chemistry, 8/2007-3/2009

Managed Process Development, radiochemical synthesis and GMP and non-GMP kilo labs

Supported Business Development

CD Project Manager for A-Bay Laboratory Build-out

2007 FDA audit of GMP kilo labs generated no 483’s

Responsible for the CMC sections of clients filings

Responsible for the tech transfer of the CMC packages to the Pilot Plant

Worked closely with Regulatory on the CMC packages and FDA inspections

Contributed to >70 client audits

Successful first Ricerca API commercial manufacture

Built the Process Chemistry Team to 40 individuals

VALEANT PHARMACEUTICALS INTERNATIONAL, Orange County, CA

Director: Global Development Technical Operations & Operational Excellence, 2005-2007

Responsible for $7.5 Million external budget. Responsible for Tech Transfer at Valeant.

Successfully managed 2 major tech transfers for DP and DS for retigabine & infergen, managed genotoxic impurities. Responsible for the CMC packages for both retigabine and infergen. Worked closely with regulatory for both filings which were successful.

Manage External Manufacturing Opportunities

Head of the Clinical Trial Supply Team activities for global activities

Completed L6L OE events

Co-PM for Project Phoenix at GDD Quality Systems at Valeant

Manage Collaboration with Ardea Biosciences

Product Life cycle & line extension management and CMC activities

Responsible for CMC sections of IND and NDA filings

VALEANT RESEARCH & DEVELOPMENT [RIBAPHARM INC., ICN]

Director of Medicinal & Process Chemistry, 2003-2005

Responsible for Chemistry R&D Efforts

Built MedChem and development Programs around several Kinase Inhibitors

Built Chemistry Group to 36 individuals

Completed Lean6Sigma Black Belt training

Developed an anti-HIV compound which is now in late stage Phase II

CHEMICAL DIVERSITY LABS, INC., San Diego, CA

Vice President, Chemistry, 2002-2003

Responsible for the Business Development and expansion of the San Diego facility, with 30 direct reports.

Developed novel computer approaches to novel compound arrays to target specific biological enzymes, generating leads and SAR studies.

Published and presented documentation on these 5 enzyme targeted libraries.

AQUASEARCH/MERA PHARMACEUTICALS, San Diego, CA; Kona, HI

Consultant on Natural Products, 2000-2005

Generated anti-infection and anti-cancer leads.

ELITRA PHARMACEUTICALS, San Diego, CA

Vice President, Chemistry, 2000-2002

Managed the collaboration with MedChem on joint development of leads

Supported Business Development

Co-developed Elitra rules for antibiotics, leading to new classes of antibiotics.

Co-Managed collaboration with LG Pharmaceuticals, generating viable leads.

Did the Tech Transfer to the acquired Montreal Facility

WYETH-AYERST RESEARCH, Pearl River, NY

Director, 1995-2000

Director, Research Administration & Special Projects, 1999-2000

Managed interface between Research and Development Departments

Lead Tech Transfer on Selected Projects

Director, Infectious Disease Chemistry Research, 1995-1999

Managed lead generation and optimization for anti infectives. Also managed external alliances with MPI on anti-infectives and Arquele on compound arrays.

STEVENS INSTITUTE OF TECHNOLOGY, Hoboken, NJ

Adjunct Research Professor, Department Chemical Sciences & Engineering, 1988-2000

OTHER RELAVANT EXPERIENCE:

AMERICAN CYANAMID COMPANY, Pearl River, NY

Project Manager for the Takeda/Lederle Japan collaboration on Biapenem, an Antibacterial Agent for Clinical Development

Project Manager for Dexfen collaboration with Interneuron Pharmaceuticals

Managed the collaboration with Medivir on antiviral FLT

Point person for the CMC activities and regulatory interactions

Project Manager for the Chemie Linz collaboration for the Development of Antibacterials

Managed the interfacing between the Research and the Development groups

Ran the Chemistry Department, Infectious Disease and Molecular Biology Research Section & Project Director

Project Director reporting to Division President

EDUCATION:

Post-Doctoral: Visiting Research Associate at The Ohio State University in Collaboration with Prof. Leo A. Paquette, Columbus, OH

Ph.D., Organic Chemistry, Brown University, Providence, RI

B.S., Chemistry, John Carroll University, Cleveland, OH

RELATED EXPERIENCES

Lean6Sigma Black Belt Management Training

Chemical Patent Practice Course - Patent Resource Group

Recombinant DNA Techniques (Prof. S. Kushner - Univ. of Georgia)

Biotechnology Patent Practice Course - Patent Resource Group

High Performance Team Techniques - The DiBianca Berckman Group

Managing the People Process: From Idea to Market Entry - Center for Creative Leadership

Media Presentations - Martel & Associates (Executive Communication Counsel)

Chemical Development & Scale-up in the Fine Chemical and Pharmaceutical Industries

ASSOCIATED EXPERIENCES:

Lean6Sigma Black Belt Management Training; Lean6Sigma Green Belt Training; Kenning Management Course; Kepner-Trego Management Course; Steffen-Steffen Time Management Course

PROFESSIONAL MEMBERSHIPS:

American Chemical Society, New York Academy of Sciences, International Society of Heterocyclic Chemistry; On Editorial or Review Boards for the Journal of Heterocyclic Chemistry, Heterocyclic Chemistry, Tetrahedron and the Journal of Medicinal Chemistry; Treasurer, International Society of Heterocyclic Chemistry; Chemical Week Advisory Panel Member; Member, The Executive Committee The International Society of Heterocyclic Chemistry (ISHC)1988-Present; Member, Finance Committee The International Society of Heterocyclic Chemistry (ISHC); Member, New Jersey Marine Sciences Consortium Sea Grant Advisory Board Member

OTHER SKILLS:

Functional in Japanese Language Speaking.

PUBLICATIONS, PRESENTATIONS, AND PATENTS: >100 Publication and >40 patents, list available on request.

REFERENCES: Available on Request

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