Search Jobs: Results: Director of Formulation Development

This is a technical CMC leadership role (Director of Formulation Development) within a rapidly expanding pharmaceutical company with multiple drugs in the development pipeline (phase I to III).  The role would not have direct reports at this time but interact with a cross-sectional groups to lead CMC activities:

 

This formulation development leader will have a strong background in pharmaceutical CMC development for small molecule drug candidates as they apply to the different phases of drug development, including:

  • Process chemistry development and scale up
  • Formulation design, development and scale up (solid orals mainly, but others as well, liquids, and semisolids)
  • QbD
  • Specification setting

 The successful candidate should also have relevant experience in the following functions:

  • Preparation of CMC sections of regulatory filings (NDA)
  • Managing contract development and manufacturing organizations (CMOs) conducting manufacturing under cGMP
  • Working with colleagues across different departments (pharm dev, process dev, analytical, quality, reg affairs) to advance company projects efficiently

 Responsibilities:

  • Provide project leadership and technical oversight on all CMC-related formulation and process development activities
  • Initiate, negotiate and manage external contracts and collaborations for cGMP manufacture at CMOs
  • Author and/or coordinate the preparation of the drug substance and drug product sections of CMC and related regulatory submissions.

 Qualifications and knowledge:

  • Ph.D. in pharmaceutical sciences or closely related, with substantial formulation development experience in the CMC area working in the development of human drug candidates. 
  • 10+ years of pharmaceutical industry experience.
  • Track record of preparation of CMC sections of regulatory submissions
  • Experience in initiating, negotiating and managing CRO and CMO manufacture of drug substances and drug products
  • Current knowledge of the GMP rules and regulations for the manufacture of APIs and pharmaceutical finished products for human clinical use
  • A good understanding of formulation and analytical development
  • Mid to small pharma experience a plus

 

Other requirements:

  • Highly motivated self-starter who is able to work well in a team environment
  • Excellent interpersonal and communication skills
  • Effective problem solving skills
  • Results oriented
  • Ability to effectively manage multiple projects to meet timelines and quality requirements
  • Flexibility and the ability to work effectively with scientists in other disciplines

Job Details

Name:   Joanne Gehas   Date Posted:   06/16/2017
Office:   Raleigh   Telephone:   (919) 760-3005
Email:   jgehas@fpcraleigh.com   Fax:   (919) 848-1062
Industry:   Pharmaceutical
Function:   Sciences   Sub Category:   Formulations Development, ...»
Keywords:   formulation, NDA, CMC, small molecule, solid orals, tablets, GMP, process development   Region:  
State:   North Carolina   City:  
Education:   PhD   Job Number:   J53990-RALE

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