Process Development Director

Company: Garudatx
Location: Cambridge
Posted on: September 18, 2023

Job Description:

The full-time role will be a key CMC leadership member, focused on developing Garuda's cell line development and manufacturing capabilities. Working closely within the R&D and CMC Departments, the ideal candidate will be responsible for leading process development, qualification, and technology transfer, in addition to establishing a well-functioning process sciences group that can perform a variety of cell manipulations (iPSC reprogramming, gene editing, expansion and differentiation) to support clinical materials production. The position is located inCambridge, MA and requires some travel to local (metro Boston) manufacturing sites.Key Responsibilities Include:

• Lead a high-performing team, consisting of engineers and scientists to define and drive the execution of Garuda's cell therapy process development strategy. This includes planning and hiring talent, technology investments, regulatory strategy as well as interaction with our external partners.
• Lead the continuous maturation of our cell therapy process development business processes.
• Lead matrixed process development teams to advance development, process characterization, technology transfer, and regulatory authoring of our candidates.
• Interface closely with R&D, Quality and External Manufacturing organizations to execute and support clinical and commercial technology transfers to internal and external facilities.
• Collaborate with key stakeholders (Mfg., Quality, Supply Chain, Clinical, etc.) to define, optimize, and maintain effective interfaces, hand-offs, and business processes
• Provide technical and organizational mentorship to leads, scientists, and engineers.
• Advance platform and functional initiatives through direct contributions and matrixed leadership
• Authoring and review of regulatory submissionsMinimum Qualifications:
  • PhD with 3+ years of related experience, MS with 7+ years of related experience, or BS with 10+ years of related experience is required.
  • Degrees in Biological, Bioengineering, Chemical Engineering or process related sciences are required. Advanced degree preferred.
  • Extensive (> 10 years) cell culture experience required. Experience with iPSC cells and their derivatives preferred.
  • At least 5 years prior cell therapy manufacturing experience required. At least 5 years working in process development and/or manufacturing of cell therapy products preferred.
  • Expertise in cell processing and culture technologies for clinical materials production required. Experience with > 15 liter scale perfusion and/or stirred tank bioreactors for cell culture preferred.
  • Strong knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820) required.
  • Strong leadership and problem-solving skills
  • Attention to detail and careful record-keeping.
  • Excellent organizational skills and ability to manage multiple projects.
  • Excellent oral and written communication skills, able to write technical reports and protocols.
  • Flexible team player excited to collaborate with internal and external partners.Preferred Qualifications:
    • Experience with cell and gene therapies; experience with iPSC-derived cell products is highly preferred.

Keywords: Garudatx, Cambridge , Process Development Director, Executive , Cambridge, Massachusetts