Wanted: Senior Quality Management Position in Pharmaceuticals

CLIFFORD L. NILSEN

RR 2 Box 135

Benton, Pennsylvania 17814

(570) 477-5042

cnilsen@epix.net

SUMMARY

Proven track record of  bottom-line improvement as an accomplished mentor, leader and problem-solve; strong in analytical chemistry, laboratory management, quality systems, cGMP compli­ance and validation, cost reduction, continuous improvement technology, training and technical management. Also have an excellent understanding of manufacturing equipment and processes. Experience includes pharmaceuticals, Class III medical devices, diagnostics and fine chemicals.

CAREER BACKGROUND AND ACCOMPLISHMENTS

NILSEN CONSULTING, Benton, PA            2003 – 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, and, design and implementation of master validation and compliance plan for a major OTC colds product firm, plus cost reduction programs via Six Sigma, Lean-based analytical and process flow improvement projects, resulting in a $7,000,000 increase in gross sales.

LYCOMING ANALYTICAL LABORATORIES, Duboistown, PA                                       1996 - 2003

As President and Laboratory Director, managed all technical activities including analytical design, technical review, quality assurance management, 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 $1,000,000 per year before sale of company to Chemir Pharma Services in July, 2003.  Had successful preapproval inspections for two (2) NDAs and three (3) ANDAs.

INDEPENDENT CONSULTING, 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

·         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.

BARR LABORATORIES INC., Pomona, New York             1990‑1992

Director of Analytical Laboratories

Responsibility for direction and maintenance of team effort in support of new product development and regulatory compliance, including quality/regulatory responsibilities for document control, CMC for ANDAs and validation. Managed a department of 70 with a multi-million dollar budget.

·         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.

·         Prepared chemistry sections for over 30 ANDA submissions.

·         Developed plan for improved operation of Q.C. department that would eliminate end‑of‑month backlogs and manage day‑to‑day priorities more efficiently.

·         Developed a system of documentation control that brought analytical methods and specification revisions up to date and into regulatory compliance.

LONZA,  Williamsport, PA       1988‑1990

Quality Control/Quality Assurance Manager

Plant responsibility for management of QA/QC functions such as product testing, complaint handling, and customer audits and data analysis for over 300 different products.

·         Designed reduced sampling‑testing protocol that resulted in 1500 man‑hour overtime reduction.

·         Implemented technology upgrade in Q.C. lab with 800 man‑hours  per year impact in labor savings. 

·         Conducted a variety of technical seminars for groups ranging  from senior managers to first‑line supervisors.

·         Strengthened market position with key accounts through direct presentation to customers.

PRIVATE FORMULATIONS INC., Edison, New Jersey        1986‑1988

Director of Quality

Responsible for direction of all quality control, quality assurance, analytical methods development and regulatory affairs for solid‑dosage, OTC drug products. Managed staff of 80.

·         Launched a 10‑month lab improvement program that resulted in  FDA inspections going from unsatisfactory to satisfactory.

·         Introduced modern Q.A. inspection techniques that eliminated 100% product testing.

·         Brought all validation activities into compliance in support of ANDA efforts.

DYNAMIT‑NOBEL, Stony Point, New York                  1974‑1986

Director of Corporate Quality Assurance

Corporate Position, responsible for quality systems, analytical and environmental chemistry, serving four business groups and three manufacturing sites.