Improver

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Amlan Dutta

Amlan Dutta

SVP, Head of Quality and Compliance

Florham Park, New Jersey

Extensive experience in developing and commercializing Vaccines, Monoclonal Antibodies, Cell and Gene Therapies, and Small Molecules. Led organizations in GxP (GMP, GCP and GLP) Quality and Technical Operations. Knowledgeable about putting together a BLA and end to end development of a biological from cell line development to final formulation. Successfully commercialized a vaccine and a fusion protein. Developed new organizations, stream-lined existing organizations, automated processes and managed the integration of organizations and processes after mergers. Remediated quality systems and managed regulatory inspections.


Experience:

  • Vice President, Biologics Quality (Celgene)
  • Executive Director, External Manufacturing Quality (Merck)
  • Vice President, Head of GPDO Quality and GQ Integration Lead (Bristol-Myers Squibb)
  • Head Biologics Quality Operations External Manufacturing (Merck)
  • Senior Vice President, Quality and Compliance (Celularity Inc.)
  • Vice President, Head of Quality (Spark Therapeutics, Inc.)

Skills:

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