Kwame Duffuor

** ******** *****

Doylestown, PA *8901

Home: 215-***-**** ac0iu5@r.postjobfree.com Mobile: 215-***-****

SUMMARY OF QUALIFICATIONS

Extensive CMC Project Management and Technical Services experience in the pharmaceutical and biopharmaceutical industries. Major accomplishments in both R&D and Manufacturing managing projects spanning: pre-IND through NDA/BLA filing, life-cycle management, and marketed product support. Adept at leading multi-disciplinary teams in a highly-matrixed environment. High-level knowledge of the drug development process including CMC, clinical, non-clinical, regulatory affairs, and commercial.

CORE COMPETENCIES

Integrated Project Plans

New Drug Development

Quality and Compliance

Budget and Resources

Technology Transfer

Stage Gate

Key Event Maps

Manufacturing

Six Sigma Methodologies

Scenario Planning

Process and Cleaning Validation

FDA and ICH Guidance

L&A Due Diligence

Small and Large Molecule

Risk Management

Planning Templates

Early and Late Development

Criticality Analysis

CERTIFICATIONS

Project Management Professional (PMP) - 2005

Regulatory Affairs Certification (RAC) - 2011

Six Sigma Black Belt - 2002

PROFESSIONAL EXPERIENCE

Duffuor Pharma Services, Doylestown, PA Sep 2016 Present

Owner, Independent Consultant/Contractor

CMC Project Management and Technical Services

JANSSEN R&D (A Johnson & Johnson Co.), Spring House, PA Jul 2005 – Aug 2016

Associate Director, Project and Portfolio Management

Managed a portfolio of R&D projects including: NME's in early and late development, small and large molecules, in and out-licensed products, external partnerships, medical affairs studies, and life-cycle management.

Built and maintained integrated project plans

Developed cost estimates, budgets, and resource requirements (fte and oop).

Partnered with R&D functions, Finance, Clinical, and Commercial to manage project timelines, budgets, and resources

Coordinated project execution activities including: development of critical questions and CQA’s, criticality analysis, application of lean early development principles, control strategy, stage gates, and risk management, and lessons learned

Developed dashboards to communicate project status across all management levels

Partnered with Finance to develop the plans and budgets needed for funding request from therapeutic area governance bodies

Performed CMC due diligence to support L&A’s, partnering, and co-development.

Developed model for high-level planning and forecasting of CMC budget and resources. Model is the standard tool for long-range financial planning and L&A due diligence.

Kwame Duffuor, PMP, RAC, Black Belt Page Two

JANSSEN SUPPLY CHAIN (A Johnson & Johnson Co.), Titusville, NJ 1997 – 2005

Principal Engineer, Technical Operations/Services

Successfully led the transfer of new products from R&D to commercial manufacturing site in Puerto Rico. Implemented manufacturing process improvements that resulted in significant cost savings, yield improvements, and waste reduction. Performed process engineering activities on major capital projects.

Supported product development in R&D to ensure ease of tech transfer, incorporation of commercial manufacturing requirements, and quality is built into processes and systems

Manufactured drug products batches for: scale up, clinical and bio-equivalency studies, characterizations, and registration stability.

Prepared CMC sections of the NDA and MAA or CTD submissions

Supported pre-and-post approval inspections (PAI’s)

Performed non-conformance investigations and implemented corrective and preventive actions (CAPA).

Application of six-sigma and design excellence tools to achieve process improvements and robustness for a new orally disintegrating tablet. Tools included: CTQ, QFD, prioritization matrix, SPC, process capability, design of experiments, ANOVA, regression analysis, acceptance sampling, quality cost analysis, failure mode analysis.

Successfully led companywide compliance program at commercial manufacturing site

Worked on a cross-functional team to build a new $200MM solid dosage manufacturing facility, and $185MM facility for the manufacture of orally-disintegrating tablets in Puerto Rico.

Process engineering role included: concept design, equipment purchase, installation, and qualifications; process, packaging, and cleaning validation; preparation of SOPs and manufacturing batch records; operator training on statistical tools to monitor process performance.

Key member of team that closed manufacturing facility after a successful transfer of 17 marketed products to a new facility in Puerto Rico.

Led companywide compliance program at commercial manufacturing site. Upgraded all marketed products to compliance levels consistence with CGMPs.

ORTHO-McNEIL PHARMACEUTICAL (A Johnson & Johnson Co.), Raritan, NJ 1989 – 1997

Senior Process Engineer

Implemented multiple engineering projects to expand manufacturing capacity, improve processes, achieve cost savings, reduce waste, and enhance safety.

Led the design, purchase, installation and qualification of numerous manufacturing process equipment

Eliminated exposure in Category 4 manufacturing facilities by implementing engineering controls including glove boxes

Achieved annual cost savings of $500,000 by using designed experimentation to optimize bead-coating process.

Introduced the use of statistical tools (including SPC, process capability, and acceptance sampling) in manufacturing operations to maintain processes in control, and troubleshoot out of control-incidents.

Managed the partnership between J&J and a generic company in a joint venture to introduce a new hormone replacement therapy. It included the construction of a new $30MM solid dosage manufacturing facility.

BRISTOL-MYERS PRODUCTS, Hillside, NJ 1986 – 1989

Senior Process/Project Engineer

Worked with R&D, pilot plant, marketing and manufacturing plants to implement processes and equipment for new and marketed consumer products. Products included OTC tablets, liquids, and antiperspirant/deodorants.

Designed and developed new processing scheme to manufacture silicon-based antiperspirant.

Performed the design, purchase, and qualification of manufacturing process equipment.

Transferred several products from pilot plant or manufacturing facilities to contract manufacturing

Worked on cross-functional team to relocate a manufacturing plant from St. Louis, MO to Morrisville, NC.

Performed the process, cleaning, and packaging validation

Led the use of statistical tools to monitor and control manufacturing processes

EDUCATION

Master of Chemical Engineering (M. Eng.), Cornell University, Ithaca, New York

Bachelor of Chemical Engineering (B.S.), Cornell University, Ithaca, New York

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