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
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