Director of Process Development (MSAT) - San Diego, CA

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Job description

**Director of Process Development (MSAT) - San Diego, CA**

We are seeking an experienced and highly motivated individual with extensive cell gene therapy experience to build and lead Process Development and Manufacturing Science and Technology teams MSAT in advancing the next generation of iPSC-derived NK cells and macrophage immunotherapies. The Director, PD, and MSAT will manage process development to develop optimized processes to manufacture our allogeneic iPSC-derived cell-therapy products. Additionally, you will manage the MSAT group that will not only be responsible for the Tech Transfer of processes to our CDMO and internal manufacturing facilities. Additionally, include developing and implementing process changes to improve manufacturing success and/or robustness. This position will report directly to the Sr. VP, Technical Operations Head of CMC. This will be a full-time position and the level of the position and compensation package will be competitive and tailored to the specific level of the candidate.

**Key Responsibilities:**

+ Provide oversight of tech transfer of products from R&D to PD, develop and optimize the process to manufacture iPSC-derived NK and macrophage cellular products, and train internal members of Tech Transfer team on the manufacturing process.

+ Provide oversight of MSAT group in the development and implementation of process improvements to enhance the success/robustness of the manufacturing process at CDMO.

+ Collaborate with internal stakeholders, Quality Assurance and Regulatory Affairs, to implement process changes.

+ Manage analysis of manufacturing data to generate strategies for process improvements and develop process limitations.

+ Ensure successful tech transfer of manufacturing process to CDMO and internal manufacturing

+ Become a key stakeholder in developing scaled-up, closed-loop manufacturing processes to support manufacturing an allogeneic cell therapy product line.

+ Collaborate with VP, Smart Manufacturing to evaluate and implement end-to-end automated manufacturing processes.

+ Provide oversight of CMC sections of regulatory e.g., IND and amendments filings made to Regulatory Agencies.

**Basic Qualifications and Experiences:**

+ Ph.D. in the relevant scientific field or Masters Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Biological Sciences.

+ A minimum of 5 years of experience managing cell-based therapy PD and/or MSAT teams.

+ Experience developing stem cells e.g, embryonic stem cells and/or iPSC, HSC manufacturing processes is required.

+ Experience with tech transferring manufacturing processes to CDMO or previous work experience at a CDMO is highly desired

+ Experience with a range of cell expansion systems e.g., G-Rex, bench scale single-use bioreactors , systems to concentrate and formulate final cell product as well as equipment and processes to rapidly implement fill finish into bags or vials.

+ Proven capability to build strong relationships and alignment with internal and external stakeholders.

+ Practical experience and knowledge of the cGMP manufacturing and regulatory requirements as applied to cell-based therapy products.

+ Highly motivated with experience in effectively hiring, mentoring, developing, and leading multi-disciplinary groups of scientists and engineers into becoming a high-performance and accountable collaborative team.

**_For immediate consideration apply today!_**

**_Questions? Please reach out to Dustin at _**

**_\#TJP2021_SPEC_**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

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