Expert Details
Biotechnology, Pharmaceuticals,
ID: 735941
Florida, USA
Designed successful Analytical strategy for 100s of IND and many BLA submissions in multiple countries.
Expert in the following areas:
Scientific writing and regulatory advice – CMC regulatory submissions and supporting documentation such as stability or validation reports and responses to Regulatory requests/questions.
Visible particle analysis/investigation, 2016 PDA Fred Simon award for paper on visible particle analysis
Analytical method development
Control strategy design
Product specification development
Stability program design
Analytical Method Validation
Scientific Writing –BLAs and INDs
Pre-inspection Audits
Training in GMP, Analytical methods, characterization and control strategy
Justification of specifications
Comparability Strategy for Biosimilars, ADCs, vaccines and proteinaceous products
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2004 | Degree: MBA | Subject: Technology Management | Institution: University of Phoenix |
| Year: 1990 | Degree: PhD | Subject: Chemistry | Institution: Rutgers, The State University |
| Year: 1986 | Degree: BA | Subject: Chemistry | Institution: The King's College |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2016 to Present | Employer: Undisclosed | Title: Sole Proprietor | Department: |
Responsibilities:Consulting with various biotech, biosimilar and pharmaceutical companies. Writing Regulatory documents, answering questions, and advising on strategies. Strength is in analytical control, specifications, comparability and impurity analysis with an emphasis on particle investigations |
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| Years | Employer | Title | Department |
| Years: 2007 to 2016 | Employer: MedImmune | Title: Senior Director | Department: Analytical Biotechnology |
Responsibilities:Directed a team of over 100 analysts responsible for all lot release and stability testing for over 50 protein-based products including monoclonal antibodies and recombinant vaccines in both early and late-stage development. |
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