Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Biotechnology, Pharmaceuticals,

ID: 735941 Florida, USA

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Expert in Biopharmaceutical molecule development and licensure. Experience with top Biotech companies (BMS, sanofi, MedImmune, AZ, Adello, etc.).
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
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.

Fields of Expertise

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