Quality Assurance Manufacturing
Resume:
RON LANG
Durham, NC *****
****.***@*****.***
Transferable Skills:
Quality experience, R&D background, clinical study management,
manufacturing transfer skills, understanding of GCPs, GMPs and ICH
guidelines, continuous process improvement experience, analytical method
validation, FDA, EMEA and Health Canada audit interactions, CAPA
development & implementation, DEA regulations, product stability and
release requirements, project management, experience in managing technical
staff, preparing SOPs and technical reports, bioanalytical method
development and business development expertise
Experience:
Senior Director, Quality Operations and Compliance
Valeant Pharmaceuticals, Durham, NC April 2010 - December 2012
- Overall responsibility to establish and direct the Corporate Quality
Program within R&D that will monitor the Clinical and Manufacturing
functions to ensure adherence to Regulatory requirements
- Develop and implement quality programs, training procedures and SOPs
that comply with GCPs, GMPs and ICH guidelines to ensure appropriate
- disposition of Commercial Product, Clinical Trial Material, the use
of raw materials and components
- Particpate on the Product Recall Committee and ensure quality issues
are addressed appropriately and decisions are communicated to
stakeholders
- Manage Quality activities including documentation control, internal
audits and quality records maintenance
- Hire staff, motivate, educate and develop employees to ensure they
understand the company's vision, quality focus and industry
regulations
- Harmonize the Quality program of companies that Valeant acquires to
ensure compliance with Regulations
- Be the Chairperson on the CAPA Committee and provide the leadership
to drive the corrections to completion within R&D
- Be the Chairperson on the SOP Oversight Group to ensure all SOPs
within R&D follow the same process within all companies and locations
- Interact diretly with FDA, EMEA and Health Canada involving Quality
issues
- Serve as a member on the Corporate Compliance Committee to help
ovrersee the Corporate Integrity Agreement
Chief Technical Officer
Slate Pharmaceuticals, Durham NC 2008 - 2009
- Provide Technical leadership to progress significant product
manufacturing changes, develop new analytical methods, design new
device concepts and generate clinical data to revise product labeling
- Provide expertise and guidance in interpreting governmental
regulations, agency guidelines and internal policies to assure
compliance. Serve as the liaison between the company and the various
governmental agencies
- Direct Quality product compliant investigations to determine root
cause, make corrections and document changes appropriately
- Interact with FDA, submit Annual Reports, Safety Reports and
Supplements
- Oversee the performance of Contract Manufacturers and Suppliers to
ensure compliance with internal polices and Regulatory guidelines
- Develop the Regulatory strategy and execute a plan for the
Manufacturing Transfer of the Products to a different facility
- Developed a Product Distribution program involving the DEA and the
Board of Pharmacies in each state
- Develop a Clinical program whereby study results would support the
development of promotion material and labeling changes
Director, New Products Business Development 1998-2008
US Pharmaceuticals
GlaxoSmithKline, RTP, North Carolina
- Closed more than 20 deals that involved in-license, co-promotions,
distribution agreements, authorized generics and divestments
involving Dermatology, Neurology, CNS, Respiratory, Oncology, GI and
Anti-infective products (Deal sheet available on request)
- Overall responsibility for working and communicating with a broad
range of internal stakeholders including R&D, Clinical, Commercial,
Finance, Legal and Manufacturing to discuss deal opportunities
- Lead deal teams through the due diligence process, organize due
diligence, prepare deal terms, participate in drafting agreements,
negotiating terms and closing the deal
- Broad based understanding of the science performed in pre-clinical
development with the knowledge of the drug development process
through manufacturing and commercialization
- Ability to develop and assess business cases and frame
recommendations to Senior Management that identify risks and ROI to
the company
- Capable of managing multiple projects and priorities across different
therapeutic groups and balance the scientific interest with
Commercial's interest
- Ability to identify drug development issues, formulate challenge
recommendations for resolution and take a broad and objective
business perspective
- Track record of excellent interpersonal influencing and communication
skills at all levels in the organization
- Experience managing complex relationships within an organization and
between organizations
- Extensive network of Business Development contacts at large and small
pharmaceutical companies
Project Director, Technical Regulatory Affairs 1996 -1998
Quality Assurance Division
Glaxo Wellcome Inc., RTP, North Carolina
- Communicate with the FDA regarding submissions and various
Regulatory documents prepared for filing
- Manage staff involved in preparing Regulatory documents that
were submitted to the FDA
- Prepared SUPAC supplements for manufacturing site transfers
involving solid dose products during the time Glaxo and BW
merged
- Submitted supplements for new analytical methods that complied
with the ICH guidelines
- Created Drug Substance and Drug Product Conformance Guides to
be used by the manufacturing sites which included formulation
information and product specifications
Manager, Quality Assurance Division, 1992-1997
Glaxo Wellcome Inc., Zebulon, North Carolina
- Manage the corporate commercial stability and product release groups
that had approximately 40 chemists each. Product Release would test
and release commercial product that complied with finished product
specifications and Stability would test product to registered
protocol commitments and ensure product could meet expiry dating and
be within product specifications
- Address technical stability issues that have an impact on product
quality
- Formulate and implement action plans to address deviations and
non-conformance to NDA stability commitments
- Prepare Regulatory submissions for NDA's, line extensions and Annual
Reports
- Prepare solid dose transfer SUPAC stability supplements to qualify
new manufacturing sites
- Manage the microbiology group which would test raw materials and
product to make sure they were within specifications and monitor the
manufacturing site's water system
- Involved in FDA audits involving PAI's and general inspections
- Implement a SPC program with stability data to perform trending
analysis
- Participated in Continuous Process Improvement Teams within
Technical Operations to look at the Quality Division to establish
metrics and performance objectives
Manager, Contract Manufacturing, 1991-1992
Technical Operations Division
Glaxo Inc., Research Triangle Park, North Carolina
- Developed partnerships with contract manufacturers and suppliers
- Developed a back-up sourcing program to ensure product supply long
term
- Establish a contract management function for the company that would
facilitate in monitoring business activities
Section Head, Bioanalytical Services, 1985-1990
Clinical Pharmacokinetics Department, Development Division
Glaxo Inc., Research Triangle Park, North Carolina
- Established a bioanalytical laboratory function that could support
marketed products for Glaxo Inc.'s medical program
- Method development and validation of all Glaxo Inc. bioanalytical
procedures in support of the Clinical Research and Development
program
- Managed and recruited a group of eight chemists and published 47
internal reports
Education:
-
Ph.D., Analytical Chemistry
University of Georgia, School of Pharmacy, 1984
-
M.S., Pharmaceutical Analysis
University of Georgia, School of Pharmacy, 1982
-
B.A. Chemistry, Emory University, 1978
Professional Memberships:
LES (Licensing Executive Society) Organization
American Association for Pharmaceutical Scientists
American Chemical Society
Sigma Xi, the Scientific Research Society, University of Georgia
Training Courses:
- Financial Reporting for Non-Financial Managers, Duke Fuqua School, 2004
- Center for Creative Leadership, Leadership Development Program,
Greensboro, NC, 1988
- GMP Annual Training, 1992-1997
- Leadership and Culture Characteristics, Glaxo Business School, RTP, NC,
1989
- Technical Writing Skills, Glaxo Business School, RTP, NC, 1990
- Introduction to Leadership Styles, Glaxo Business School, RTP, NC, 1990
- Leadership and Influence, Glaxo Business School, RTP, NC, 1991
- Karass Negotiations, Glaxo Business School, RTP, NC, 1991
- Managing Contracts for Peak Performance, National Contract Management
Assoc. 1991
- Managing for Financial Results, Glaxo Business School, 1991
- Foundation of Leadership, Glaxo Business School, 1993
Awards:
- CEO Award at GlaxoWellcome, 2000
- GSK Spirit Awards, 2002-2004
- American Chemical Society Excellence in Research, UGA Pharmacy 1983
Boards:
- Crimestoppers of Durham, NC - Became a Board Member in 2012
Publications & Abstracts
1. Lang, J.R., Stewart, J.T., Honigberg, I.L. Post-column air-segmentation
reactor for the fluorometric detection of reserpine by liquid
chromatography, J. of Chromatography, 252, 288-292 (1982).
2. Lang, J.R., Stewart, J.T., Honigberg, I.L. Post-column photo-chemical
reactor for the fluorometric detection of reserpine by high performance
liquid chromatography, J. of Chromatography, 264, 144-148 (1982).
3. Lang, J.R., VanAntwerp, J. High performance liquid chromatography assay
of thiamine hydrochloride and thiamine montitrate with separation from
manufacturing impurities, Hoffmann-LaRoche Internal Report, 1982.
4. Hong, P.T.R., Lang, J.R., Wood, G.C., Meyer, M.C. High performance
liquid chromatographic determination of acetazolamide in human plasma, J.
of Liquid Chromatography, 8, 1465-1473 (1985).
5. Stewart, J.T., Lang, J.R., Honigberg, I.L. Flow injection analysis of
carboxylic acid drugs using cationic dyes and on-line ion-pair
extraction, J. of Liquid Chromatography, 11, 3353-3373 (1988).
6. Lloyd, T.L., Lang, J.R. Robotic versus manual HPLC assay: Precision
and accuracy comparison for ranitidine in human serum; Advances in
Laboratory Automation Robotics, Vol. 6, 1989.
7. Lang, J.R., Bolton S. A comprehensive method validation strategy for
bioanalytical applications in the pharmaceutical industry. (Part 1:
Experimental), J. of Pharmaceutical and Biomedical Analysis, 9, 357-361
(1991).
8. Hart, R.W., Lang, J.R. Determination of loxtidine in human serum by
capillary column gas chromatography with nitrogen-phosphorous detection.
J. of Chromatography Biomedical Applications, 533, 235-240 (1990).
9. Bland, R.E., Tanner, R.N.J., Chern, W.H., Lang, J.R. Determination of
albuterol concentrations in human plasma using solid phase extraction and
high performance liquid chromatography with fluorescence detection, J. of
Pharmaceutical and Biomedical Analysis, 8, 591-596 (1990).
10. Lang, J.R., Bolton, S. A comprehensive method validation strategy of
bioanalytical applications in the pharmaceutical industry (Part 2:
Statistical Analyses), J. of Pharmaceutical and Biomedical Analysis, 9,
435-442 (1991).
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