Associate Director, Integrated Drug Substance Development
Description

  

Codiak is driven by a belief that the most innovative medicines are found at the intersections of scientific fields and that problem-solving across disciplinary boundaries is necessary to be a leader in bionanoparticle therapeutics.  The Integrated Drug Substance Development (IDSD) group at Codiak, which spans mammalian cell culture, purification, and payload loading, is seeking a talented, creative, and passionate cell culture scientist/engineer to bring impactful therapeutic modalities to patients with unmet medical needs. The IDSD group prides itself on integrity, collaboration, and flexibility while gaining satisfaction in bringing promising new modalities to the clinic.


The Associate Director is a senior role within Codiak’s CMC organization, responsible for leading an integrated drug substance development team. This position will be responsible for providing stewardship of cell culture advances across Codiak, including perfusion cell culture and scale-up from lab to manufacturing scale. Experience in early or late-stage development with expertise in perfusion cell culture is expected along with a nuanced understanding of phase-appropriate development strategies. As the head of an integrated team, the successful candidate will have a working knowledge of downstream unit operations or an interest in expanding one’s knowledge base. Excellent communication skills and demonstrated aptitude in collaborating across functions are essential.  


Given Codiak’s leadership in the emerging field of exosome therapeutics, individuals motivated to drive technology and innovation are ideally suited for this role. A key focus will be on process intensification to increase productivity. Knowledge of micro-scale and high throughput cell culture technology and practices is desirable. 


  

Essential Functions/Responsibilities

  1. Lead and mentor scientists/engineers with upstream and downstream processing expertise.
  2. Guide process development from lab-scale to tech transfer and GMP production at external CMOs and internal facilities.
  3. Interface with Research, Development, Quality, and Manufacturing colleagues to advance clinical programs.
  4. Collaborate cross-functionally with Regulatory to prepare regulatory submissions.
  5. Support expansion of internal GMP manufacturing capabilities.
  6. Conceive and implement studies to identify CPPs, CQAs and expand exosome bioprocess understanding.
  7. Collaborate with peer lab groups to sustain and foster a culture of integration, innovation and continuous improvement in the Process Sciences organization
  8. Along with other senior members of the CMC staff, help shape goals and strategic vision for the CMC organization. 
Requirements

  

  • PhD or commensurate years of education and experience with a scientific degree in biology, biochemistry, biochemical engineering, or related scientific discipline.
  • Typically requires 10 years experience (including Postdoc)
  • Hands on experience with bench and pilot/production scale bioreactors.
  • Experience in development and transfer of production processes for biologics, with specific expertise desirable in perfusion cell culture and in viral vector production; 
  • Excellent communication and presentation skills (oral and written);