Quality Assurance Manager
Resume:
AMOS C. LANG
Falls Church, VA 22046
Phone 703-***-****
Email: ****.*.****@*****.***
EDUCATION:
Dickinson College in Carlisle, PA.
Graduated (May 1998) with a B.S. in Biology and a B.A. in Political Science.
WORK EXPERIENCE:
Director, Biodefense Program Management
Tekmira Pharmaceutical Corporation, Burnaby, BC (Sep 2010 – Jun 2011)
Lead and managed drug development programs for biodefense medical countermeasures for clients, including a $140 million hemorrhagic fever virus program for the US Department of Defense (DoD). Performed risk management, prepared regular reports and ensured compliance with the contract and successful completion of product development program objectives on time and on budget.
Program management activities, including implementation and execution of Earned Value Management System (EVMS) cost and schedule planning and reporting, monitoring of ongoing project plans and contract progress reports, in accordance with applicable U.S. Federal Acquisition Regulation (FAR) and Defense Federal Acquisition Regulation Supplement (DFARS).
Guided programs through key milestones and decision gates, including project kickoff, and Integrated Baseline Review (IBR), with the main goal of product licensure through FDA.
Scientist / Mid-Level Strategist
Camber Corporation, Falls Church, VA (Apr 2009 – Sep 2010)
Working for the Department of Defense's Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), coordinated medical transition planning from basic discovery (Joint Science and Technology Office) to advanced development and fielding. Perform regular investigation of ongoing R&D at JPEO-CBD directorates and prepare reports for leadership on status and execution of funding.
Vaccine Manager
Goldbelt Raven, LLC, Frederick, MD (Mar 2006 – Apr 2009)
Provide technical guidance and project management on existing and future biodefense vaccines for the Department of Defense’s Joint Vaccine Acquisition Program (JVAP), protecting the Warfighter from specific biological weapon threats. Responsible for the management of advanced development and procurement activities of $18 million, $1,072 million vaccine programs.
Quality Assurance Consultant
Gene Logic, Inc., Rockville, MD (Feb 2006 – Mar 2006)
Responsible for writing and training of employees for rollout and implementation of GMP system of manufacturing. Drafted quality manual and training program, and updated SOPs for core manufacturing processes for Affymetrix GeneChip production.
Validation Specialist
Kaztronix, Frederick, MD (Feb 2005 – Oct 2005)
Responsible for providing (re)validation support for new and old equipment for contracted facility in Frederick, MD. Wrote and executed validation plans (including IQ, OQ, PQ documentation) for equipment and process, supporting the manufacturing of Synagis product. Developed improvements to Quality documentation standards, and assisted in scheduling meetings with other departments.
Quality Engineer
Eli Lilly & Company, Manassas, VA (Feb 2004 – Dec 2004)
Supported qualification, validation and maintenance activities. Reviewed and approved documentation (specifications, drawings, protocols, change controls, procedures, PQEs), etc., in support of new insulin production facility. Chief areas of responsibility include barrier isolator technology, parenteral filling equipment, and manufacturing execution systems (MES). Also performed vendor audits, reliability studies for new equipment and gap analyses of regulatory inspection observations & compliance for all Eli Lilly manufacturing facilities.
Manager, Drug Manufacturing
BioReliance Corporation, Rockville, MD (Aug 2000- Sep 2003)
Responsible for managing daily operations, supervising staff of 8 employees in production area involving formulation, component preparation, preparation of isolators (VHP), filling/lyophilization, and finishing. Participated in qualifying and validating new production facility and equipment inside. Wrote and executed validation documents (IQs, OQs, and PQs). Additionally, aided in formulation development and pilot studies involving filling and lyophilization applications. Also drafted or adapted departmental SOPs, and trained employees on operation of filling and manufacturing support equipment and other various manufacturing protocols.
Supervisor of Parenteral Products
Organon Inc., West Orange, NJ. (Aug 1998 – Dec 1999)
Responsible for managing daily operations, supervising staff of 36 employees over elements of production in the areas of Aseptic filling/lyophilization, formulation, component preparation and in-process control of sterile pharmaceuticals. In addition, was responsible for maintaining and adapting cGMPs and departmental SOPs, and training of new employees of new or revised manufacturing methods and equipment.
CERTIFICATIONS AND PROFESSIONAL DEVELOPMENT:
o 2009 Active US Government Secret security clearance
o 2009 Program Management Professional Equivalence through DoD Acquisition
Level II – Defense Acquisition University
o 2004 Introduction to GMP Auditor Certification – International Society for Pharmaceutical Engineering
TECHNICAL SKILLS:
Computer: Windows and Macintosh PC working environments. Microsoft Office Programs, Project, WordPerfect, Quattro Pro, Lotus Notes and DNAStar. HTML programming and graphics design, and interface.
Equipment:
o Pharmaceutical microbial processing equipment: including fermenters, microfluidizers, multiple HPLC types
o Filling & finishing equipment: including high-speed filling lines, lyophilizers vial/ampule/syringe washing & depyrogenation, VHP and steam sterilization
o Analytical testing: qPCR, spectrophotometer, plate reader, electrophoresis, basic lab equipment
o Automation (Allen Bradley, Rockwell, Siemens)
-REFERENCES AVAILABLE UPON REQUEST-
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