Associate Director, Biologics Process Development

Location: OH
Job Type: Direct Hire
Salary: $120,000.00 - $145,000.00
Degree: Master of Science; Doctor of Philosophy;
Date: 12/7/2017
Job ID: 02488285
Job Description
Company is seeking a Principal Engineer to lead projects in the Biologics process development and clinical manufacturing projects. The individual will design, develop, scale-up and optimize drug substance and drug product unit operations for protein therapeutics. Experience managing projects from Discovery integration through GMP manufacturing, with both internal and external partners are required. The candidate should have strong technical, communication and interpersonal skills, be able to multi-task, and to work across diverse, cross-functional teams both onsite and across sites.

The key duties of this role are to provide technical leadership in biologic/protein therapeutic process development and early stage clinical manufacturing (Phase I/II). The role will also be responsible for leading tech transfer of drug substance and drug product processes to CMOs for Phase III and Commercial operations. Extensive experience in upstream process development and early phase clinical manufacturing required. Demonstrated ability to develop, optimize and scale up robust bioreactor processes using statistical experimentation and QbD principles is essential. Additionally, knowledge of chromatography, lyophilization, filtration and viral reduction downstream process steps is highly desirable. Mentoring junior level Scientists and Research Associates is also essential.
 

QUALIFICATIONS

  • Extensive experience in statistical design of experiments and QbD principles
  • Process development in upstream (bioreactor)
  • Process definition through optimization
  • Strong problem solving skills
  • Experience in developing process risk assessments
  • Clinical manufacturing to commercial manufacturing of DS
  • Sound working knowledge of current regulatory requirements
  • Experience with process validation
  • Experience with commercial manufacturing
  • DP manufacturing experience helpful
  • Strong writing skills required for process documentation, technical reports and regulatory filings
  • Build strong relationships with internal and external stakeholders to advance program goals

EDUCATION AND EXPERIENCE

MS or PhD in Chemical or Bioengineering

MS with 12-15 years bioprocessing experience in mammalian cell culture

Ph.D. with 8-10 years bioprocessing experience in mammalian cell culture

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Command Consultants, Inc * 602 Arkland Place * Nashville, TN 37215
Telephone: (917) 804-5966 NY or (615) 730-7945 Nashville * E-mail mark@commandconsultants.com

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