Gopal Krishna, Phd

Gopal Krishna, Phd Email and Phone Number

CMC Pharmaceutical Development and Technical/Manufacturing Operations @ Seelos Therapeutics, Inc.
Gopal Krishna, Phd's Location
Parsippany, New Jersey, United States, United States
Gopal Krishna, Phd's Contact Details

Gopal Krishna, Phd work email

Gopal Krishna, Phd personal email

n/a

Gopal Krishna, Phd phone numbers

About Gopal Krishna, Phd

Over 25 years of formulation development and commercial manufacturing experience of solid, liquid and parenteral dosage form of small molecules, large molecules, and biologics. Effective leadership, strong planning and organizational skills, strategic planning, good communication skills. Handled multiple projects with attention to detail. Management of contractual manufacture and supply chain of API and drug product. Provide technical expertise and CMC input during evaluation of new business opportunities, and co-development of late stage compounds. Thorough understanding of cGMP and GLP and CMC-related regulations and guidance documents for IND/NDA global submissionsWell rounded development experience taking drug from pre-clinical to IND/NDA stage. Proven success in developing formulations and manufacturing processes, transferring technology, creating procedures and documentation, and establishing regulatory compliance. Extensive experience in freeze drying technology, formulation development of parenteral dosage forms including parenteral emulsions, oral solid and liquid formulations, and analytical techniques.

Gopal Krishna, Phd's Current Company Details
Seelos Therapeutics, Inc.

Seelos Therapeutics, Inc.

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CMC Pharmaceutical Development and Technical/Manufacturing Operations
Gopal Krishna, Phd Work Experience Details
  • Seelos Therapeutics, Inc.
    Head Of Cmc Pharm Dev And Technical Operations
    Seelos Therapeutics, Inc. Aug 2018 - Present
    New York, New York, Us
    View
  • Vero Biotech, Llc
    Cmc-Technical/Manufacturing Operations And Regulatory Consultant
    Vero Biotech, Llc Jan 2018 - Jul 2018
  • Vyera Pharmaceuticals, Llc
    Vice President, Cmc
    Vyera Pharmaceuticals, Llc Nov 2015 - Sep 2017
    New York, Ny, Us
    Responsible for all aspects of Chemistry, Manufacturing and Control (CMC) activities for drug products and API. Provide strategic leadership in the management of new product development and commercialization strategy. Manage relationships with CMO's and CRO's, and execute CMC development and manufacturing plans for regulatory compliant and commercially viable cGMP manufacturing process. Represent CMC in regulatory agency meetings and provide CMC input for regulatory filings.
    View
  • The Medicines Company
    Vice President, Pharmaceutical Development
    The Medicines Company Jul 2011 - Nov 2015
    East Hanover, Nj, Us
    Responsible for pharmaceutical development including API, dosage form manufacturing, CMC
    View
  • The Medicines Company
    Sr. Director, Technical Operations And Strategic Process Innovations
    The Medicines Company Sep 2003 - Jun 2011
    East Hanover, Nj, Us
    Responsible for Global pharmaceutical manufacturing and product development functions, including the building of sustainable partnerships with contract manufacturers and contract research companies for the innovative development and manufacture of drug products. Responsibilities include preparation and filing of the CMC sections for NDA and IND applications in the USA, and Europe. Responsible for resource planning and manufacturing budget, contract packaging and warehousing. Provide technical assistance in life cycle management, patent extension/protection. Trouble shoot manufacturing and analytical issues. Function as the liaison to Regulatory agencies for technical portions of application. Manage budgets ($10 million+), supervise Ph.D. and MS scientists and administrative staff. Member of Business Development due diligence and acquisition team providing strategic direction, regulatory assessment, evaluating COGS, technical feasibility, manufacturability etc.
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  • Vion Pharmaceuticals
    Associate Director, Pharmaceutics
    Vion Pharmaceuticals Nov 1996 - Aug 2003
    Us
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Gopal Krishna, Phd Skills

Gmp Pharmaceutical Industry Technology Transfer Biotechnology Pharmaceutics Formulation Drug Development Ind Fda Life Sciences Regulatory Affairs Biopharmaceuticals Regulatory Submissions Sop Drug Delivery Validation Oncology Lifesciences R&d Drug Discovery Cmc New Drug Application Quality Control Strategy

Gopal Krishna, Phd Education Details

  • The University Of Tennessee Health Science Center
    The University Of Tennessee Health Science Center
    Paenteral Technology
  • Nagpur University
    Nagpur University
    Pharmaceutics

Frequently Asked Questions about Gopal Krishna, Phd

What company does Gopal Krishna, Phd work for?

Gopal Krishna, Phd works for Seelos Therapeutics, Inc.

What is Gopal Krishna, Phd's role at the current company?

Gopal Krishna, Phd's current role is CMC Pharmaceutical Development and Technical/Manufacturing Operations.

What is Gopal Krishna, Phd's email address?

Gopal Krishna, Phd's email address is go****@****dco.com

What is Gopal Krishna, Phd's direct phone number?

Gopal Krishna, Phd's direct phone number is +197364*****

What schools did Gopal Krishna, Phd attend?

Gopal Krishna, Phd attended The University Of Tennessee Health Science Center, Nagpur University.

What skills is Gopal Krishna, Phd known for?

Gopal Krishna, Phd has skills like Gmp, Pharmaceutical Industry, Technology Transfer, Biotechnology, Pharmaceutics, Formulation, Drug Development, Ind, Fda, Life Sciences, Regulatory Affairs, Biopharmaceuticals.

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