David Grote

regulatory knowledge

team-building leadership skills

technical expertise

creative problem-solving abilities

microbiology

contamination investigation

regulatory audit preparation and defense

process validation

validation

understanding of PAT

risk based validation

21st century cGMP

part II compliance.

Experienced biopharmaceutical leader with broad expertise in validation and quality assurance

team building

and cGMP compliance. Strong knowledge base in biotechnology bulk manufacturing and fill/finish. Broad science background with strong technical and troubleshooting skills. Have led large execution teams of over 40 staff and contractors on multiple successful projects. Frequently requested speaker on process analytical technology and risk-based validation approaches at conferences. Skilled leadership and executive coach with experience leading teambuilding activities. Experienced with web site design and small business startup

management

and marketing.