Melissa Joseph

Melissa Joseph Email and Phone Number

Principal Consultant and Owner @
Melissa Joseph's Location
Greensboro--Winston-Salem--High Point Area, United States
Melissa Joseph's Contact Details

Melissa Joseph work email

Melissa Joseph personal email

n/a

Melissa Joseph phone numbers

About Melissa Joseph

CMC Pharmaceutical Development Consulting with experience ranging from drug substance through drug product manufacture, packaging, and distribution including relevant quality and regulatory support.

Melissa Joseph's Current Company Details
Chymesis, LLC

Chymesis, Llc

Principal Consultant and Owner
Melissa Joseph Work Experience Details
  • Chymesis, Llc
    Principal Consultant And Owner
    Chymesis, Llc Apr 2015 - Present
    Greensboro/Winston-Salem, North Carolina Area
    Consulting support for CMC Pharmaceutical Development Preclinical through Registration and Commercial Manufacture. Areas of expertise include:Drug Development: Experience in management and execution of all development aspects impacting drug substance, drug product, packaging, labelling and distribution to clinical trial sites.CMC Regulatory Support: CTD authorship of CMC sections to support IND, NDA, ANDA, and post NDA approval filings. Face-to-face and written interaction with FDA pre and post filing and pre and post approval. Due Diligence: Experience assessing pharmaceutical assets and timelines.Commercial Manufacturing and Compliance Support: Strategic planning to support commercial manufacturing goals, ensuring efficiency and compliance. PAI audit participation and Warning Letter remediation.
  • Targacept, Inc.
    Senior Director Pharmaceutics & Analytical Research And Development & Gmp Compliance
    Targacept, Inc. Jan 2014 - Mar 2015
    Targacept Inc.
    Oversee all CMC activities including manufacture, packaging, and distribution for drug substance and drug product supporting preclinical through developmental phases. Coordinate CMC activities as they interface with QA and Regulatory affairs.
    View
  • Targacept, Inc.
    Group Leader Analytical Research And Development
    Targacept, Inc. May 2008 - Jan 2011
    View
  • Banner Pharmacaps
    Director Of Quality Control
    Banner Pharmacaps May 2006 - Feb 2008
  • Banner Pharmacaps
    Manager Of Analytical Development
    Banner Pharmacaps Nov 2001 - May 2006

Melissa Joseph Skills

Laboratory Chromatography Clinical Trials Cro Gas Chromatography Chemistry Hplc Gmp Regulatory Affairs Validation Quality Assurance Method Development Cleaning Validation Wet Chemistry Gc Ms Dissolution Ftir Drug Discovery Quality System Analytical Chemistry V&v Drug Development Pharmaceutics Clinical Development Mass Spectrometry Lc Ms Formulation Cmc Quality Control Pharmaceutical Industry Technology Transfer Glp Uv/vis Fda R&d Sop Ind

Melissa Joseph Education Details

Frequently Asked Questions about Melissa Joseph

What company does Melissa Joseph work for?

Melissa Joseph works for Chymesis, Llc

What is Melissa Joseph's role at the current company?

Melissa Joseph's current role is Principal Consultant and Owner.

What is Melissa Joseph's email address?

Melissa Joseph's email address is me****@****ept.com

What is Melissa Joseph's direct phone number?

Melissa Joseph's direct phone number is +133665*****

What schools did Melissa Joseph attend?

Melissa Joseph attended Duke University, Duke University.

What skills is Melissa Joseph known for?

Melissa Joseph has skills like Laboratory, Chromatography, Clinical Trials, Cro, Gas Chromatography, Chemistry, Hplc, Gmp, Regulatory Affairs, Validation, Quality Assurance, Method Development.

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