Associate Director, Process Development-Upstream

Company: Remedy Solutions
Location: Raleigh
Posted on: January 27, 2023

Job Description:

Associate Director, Process Development-Upstream

• Full-timeRemedy Solutions is a dynamic recruiting firm representing US and International companies.A biopharm company located in North Carolina is seeking an Upstream Process Development Associate Director. This person will manage and serve as technical lead for a team of 7-8 direct reports in cell culture and harvest of mammalian cell lines (mainly CHO variants) in support of process development, scale-up, and technology transfer to cGMP manufacturing for Phase I through Phase III processes as well as build and maintain client relationships.
  • Serves as a subject matter expert, providing technical oversight to the team, and training to junior scientists. Familiar with functional area interdependencies, including cell culture, purification, analytical, and site readiness.
  • Develops the pathway/ technical direction for team members.
  • Provides technical leadership for product development efforts in the process and manufacturing areas. Conceptualizes and proposes process development and manufacturing based on biopharmaceutical data. Has in-depth understanding for data analysis and interpretation of cell culture data.
  • Provides technical support for clinical manufacturing and product testing.
  • Works toward developing a broad knowledge of state-of-the-art scientific principles, understanding of the evolving regulatory requirements; provide technical leadership in the group, serve as in-house advisor on key scientific discipline areas.
  • Oversees cell culture-specific project plans, including raw materials and equipment availability, in preparation of laboratory and pilot-scale runs from their team.
  • Responsible for producing high quality documentation and client reports suitable for publication and regulatory requirements.
  • Adheres to all safety requirements and assures that departmental employees comply with required safety procedures.
    • Degree within Chemical Engineering, Biotechnology or related area:
      • Master's degree with 10+ years' experience
      • Ph.D. with 6+ years' experience
      • Able to react to change productively and handle other essential tasks as assigned.
      • Subject matter expert in areas of process development including high throughput technologies such as ambr, technology transfer, scale-up of processes to pilot and manufacturing scales.
      • Advanced ability with Microsoft Office (Excel, PowerPoint and Word). Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).
      • Demonstrates ability to work both independently and as a member of a team.
      • Excellent customer service skills and the ability to meet strict client deadlines.
      • Flexibility of hours to support cell culture processes over weekend and holidays.
      • Ideal Candidate will have Ph.D. and significant experience working with mammalian cell culture and bioreactors and will have an in-depth understanding of biological and engineering factors that influence cell culture process performance and product quality. In addition, demonstrated experience to lead a team and work in multi-disciplinary team environment.All of your information will be kept strictly confidential according to EEO guidelines.

Keywords: Remedy Solutions, Raleigh , Associate Director, Process Development-Upstream, Executive , Raleigh, North Carolina