Clifford Nilsen Current Resume Page 1 of 4
CLIFFORD NILSEN – CURRENT RESUME PAGE 1 OF 4
CLIFFORD L. NILSEN
RR 2 Box 135
Benton, Pennsylvania 17814
(570) 477-5042
OBJECTIVE
Provide high-quality technical and regulatory services to the pharmaceutical and nutraceutical industries.
SUMMARY
Extensive experience in pharmaceutical and chemical industries. Strong in analytical chemistry, general cGMP compliance, validationand laboratory management.
CAREER BACKGROUND AND ACCOMPLISHMENTS
NILSEN CONSULTING, Benton, PA2003 – Present
Resumed consulting practice after sale of Lycoming Analytical Laboratories in July, 2003. Accomplishments include cleaning validation design and execution, including method development and validation that resulted in client going from Warning Letter to a no 483 follow-up inspection by FDA. On-going projects include complete overhaul of laboratory systems for a prescription drug manufacturer—regulatory and analytical.
LYCOMING ANALYTICAL LABORATORIES, Duboistown, PA1996 - 2003
As President and Laboratory Director, manage all technical activities including analytical design, technical review, supervision of staff, document preparation and review, regulatory compliance, security and customer interaction. Grew company from startup in January 1997 to a business level of about $1,00,000 per year before sale of company to Chemir Pharma Services in July, 2003.
SELF-EMPLOYED, Hughesville, PA 1992 - 1996
Provided technical and laboratory management consulting services to pharmaceutical and chemical clients in the area of analytical laboratory improvement, cGMP and GLP compliance and problem resolution, training, management planning and technology upgrades.
- As a managing consultant, brought the chemistry/lab into substantial compliance for firm under FDA consent decree. Subsequent inspection by FDA yielded no 483 observations under chemistry.
- Brought bulk pharmaceutical firm into compliance by design and implementation of a total plan that included process, cleaning and analytical methods validation. Firm went from warning list to a 483 having only three (3) minor observations. Represented firm during FDA inspection.
- Through audit, training and use of statistical Q.C. techniques, designed and implemented a Q.C. efficiency program that resulted in a $60,000 per year reduction in testing costs.
- Developed a successful lab management plan for a major pharmaceutical contract lab that resulted in improved morale, elimination of end-of-month backlogs and greater productivity.
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BARR LABORATORIES INC., Pomona, New York 19901992
Director of Analytical R&D
Responsibility for direction and maintenance of team effort in support of new product development and regulatory compliance.
- Designed improved testing modalities for key drug products resulting in a $300,000 per year cost reduction.
- Managed the firm out of FDA comment letter backlog, permitting faster approval for new drug products.
- Eliminated departmental turnover through rearrangement of job assignments and realignment of responsibilities.
- Implemented structured management of department, resulting in 100% ontime completion of both short and longterm projects.
- Developed plan for improved operation of Q.C. department that would eliminate endofmonth backlogs and manage daytoday priorities more efficiently.
- Developed a system of documentation control that brought analytical methods and specification revisions up to date and into regulatory compliance.
- Greatly increased departmental office efficiency through the use of advanced computer technology for the management of scientific information.
SELF-EMPLOYED, Hughesville, PA 19881990
Quality Control/Quality Assurance Manager
Plant responsibility for management of QA/QC functions such as product testing, complaint handling, customer audits and data analysis for over 300 different products.
- Designed reduced samplingtesting protocol that resulted in 1500 manhour overtime reduction.
- Implemented technology upgrade in Q.C. lab with 800 manhours per year impact in labor savings.
- Designed, wrote and implemented Q.C. management software package that standardized data analysis and reporting. Package adapted at other plant sites.
CLIFFORD NILSEN – CURRENT RESUME PAGE 1 OF 4
- Designed, implemented and installed telecommunications software and hardware for automatic computergenerated certificates of analysis which saved on manday per week in clerical labor and enhanced Company's quality image.
- Conducted a variety of technical seminars for groups ranging from senior managers to firstline supervisors.
- Strengthened market position with key accounts through direct presentation to customers.
PRIVATE FORMULATIONS INC., Edison, New Jersey 19861988
Director of Quality
Responsible for direction of all quality control, quality assurance, analytical methods development and regulatory affairs for soliddosage, OTC drug products.
- Launched a 10month lab improvement program that resulted in FDA inspections going from unsatisfactory to satisfactory.
- Introduced modern Q.A. inspection techniques that eliminated 100% product testing.
- Computerized lab operations, installed LAN and provided training and modified MRP system software, eliminating 2day delay moving products from Manufacturing to Shipping after lab approval.
DYNAMITNOBEL, Stony Point, New York 19741986
Quality Assurance Manager
Corporate Position, responsible for analytical and environmental chemistry, serving four business groups and three manufacturing sites.
- Reorganized and upgraded Stony Point, NY Q.C. lab, resulting in a doubling of lab efficiency.
- Designed Q.C. department for Mobile, Alabama plant. Implemented all phases of project up to and including actual plant startup.
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EDUCATION
M.S.in Chemistry (ACS accredited) Wagner College
Graduate courses in advanced chemistry
Continuing Education in computers and electronics
Professional Courses in analytical instrumentation
PUBLICATIONS
Textbooks entitled "Managing the Analytical Laboratory; Plain and Simple", 1996, and AThe Q.C. Laboratory Chemist; Plain and Simple@,1998, both from Interpharm Press, Inc., Buffalo Grove, IL. Columnist for Pharmaceutical Quality & Formulation Magazine and Food Quality Magazine.
SPEAKING ENGAGEMENTS
- American Chemical Society National Tour Speaker
- Faculty Member, The Parental Drug Association (PDA).
- American Laboratory Management Association
- Barnett International
CERTIFICATION
Six Sigma Black Belt