Associate Director, Process Development

Sarepta Therapeutics   •  

Andover, MN

8 - 10 years

Posted 183 days ago

This job is no longer available.

The Position:

This position is part of the process development team, focusing on strategic planning and tactical execution of PPMO platform technology development, and continuous improvement of PMO platform technology, in conjunction with cross functional teams. He/she will lead the process development effort for feasibility evaluation, design, scale up assessment, and participation in internal production and technology transfer to external CMO. The candidate will also participate in assessing new and emerging technologies and developing strategies to incorporate the appropriate technologies into existing development pipeline. The ideal candidate will be well-organized with key competencies in all aspects of process development, especially in support of IND enabling activities, with skillsets including demonstrated subject matter expertise, effective interpersonal skills, and familiarity with IND/NDA filing requirements.

 

Primary Responsibilities Include:

  • Manage resources and progresses of overall process development activities
  • Identify opportunities for potential process improvement of existing platform technologies, and develop alternate processes, including upstream synthesis and downstream purification
  • Identify potential gaps and risks of existing processes/procedures, prioritize, and develop mitigation plans
  • Strategize development plans for PMO and PPMO platform technologies and benchmark with external industrial standards
  • Accumulate process knowledge to maintain and strengthen Sarepta’s global leadership position on the manufacturing process of oligonucleotide and the analogs  
  • Establish best practice for PMO and PPMO process development to provide guidance for future technology development within a QbD framework
  • Evaluate emerging technologies, such as PAT and process modeling tools, and their potential incorporation into the existing processes/operations based on risk and impact assessment
  • Collaborate with Manufacturing, Supply Chain, Quality Control, and Quality Assurance to support ongoing manufacturing activities
  • Act as CMC point of contact for early phase development and production
  • Support regulatory filings

 

Education and Skills Requirements:

  • Ph. D in organic/physical/analytical chemistry, or chemical/biochemical engineering
  • Over 8 years of process development or manufacturing experience, familiar with current ICH and FDA guidelines
  • Over 2 years of management experience, working with a diverse group of direct reports
  • Strong leadership and interpersonal skills with the ability to motivate others, and communicate effectively across CMC functional areas
  • Deep understanding and strong technical background in modern analytical science, PAT, and a demonstrated track record of their application in process development
  • Alignment with Sarepta Values of teamwork, excellence, innovation, drive, compassion, and resilience
  • Broad experience in discovery research, process development, and/or scale up experiencepreferred
  • Experience in downstream process development, e.g., purification, TFF and Lyophilization, preferred

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