Precigen Inc., a wholly owned subsidiary of Intrexon, is advancing an
exciting pipeline of novel cell and gene therapy products.  We are
seeking a Scientist, Cell Therapy Process Development who will manage
the process development, process optimization and manufacturing
troubleshooting in support of our lead cellular and gene therapy
candidates. The Scientist will work closely with internal program
stakeholders and the CMC team to develop manufacturing processes and
supporting analytical procedures that are suitable for use in GMP
manufacturing of a wide range of clinical trial materials and
participate in the technology transfer to contract manufacturing and
testing organizations.
The ideal candidate will have demonstrated
experience with gene and cell therapy product design. Experience with
modified T cell products (CAR-T, TCR) is preferred, but not required.

Lead process development /scale up activities for manufacturing of Precigen’s CAR-T, TCR cell product, as well as non-viral and viral vector products.

Participate in and provide manufacturing process troubleshooting support.

Work with program stakeholders in developing and implementing analytical methods for the manufacturing process.

Participate in team effort to establish early product definition, manufacturing science, and method of delivery and use in the clinic.

Develop and maintain detailed and comprehensive project budgets.

Prepare and participate in technology transfers to CMOs and contract testing laboratories.

Participate in the preparation of CMC sections for regulatory submissions (IND, Annual Reports, and BLA), invention disclosures, progress reports, and publications.

Present updates to project teams on process development and manufacturing support activities.

Maintain a high level of knowledge in gene and cell therapy, particularly in the field of CAR-T product development and manufacturing.

Collaborate with other internal Precigen departments with an eye toward future commercialization of our exciting biological products.

Serve as an internal resource for Precigen R&D regarding manufacturing science, analytical, formulation and delivery issues.

              
EDUCATION AND EXPERIENCE:

Ph.D. degree in Chemical Engineering, Molecular Biology, Analytical Chemistry, Immunology or equivalent with 5+ years’ experience in biotech development with particular experience in gene and cell therapy product design. Experience with oncology, gene modified T cell products (CAR-T, TCR) a plus.

Experience and knowledge in cell and gene therapy product design.

Experience and knowledge in process development for GMP cell therapy and vector product manufacturing.

Experience and knowledge in analytical development and implementation for GMP cell therapy and vector product manufacturing.

Experience in immunology.

Experience with technology transfer.

DESIRED KEY COMPETENCIES:

Excellent communication skills, perform well in a team environment

Self-motivated and independently minded.

Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.

Self-organizer, meticulous hands-on habits, keen attention to detail.

Strong quantitative and analytical skills.

Proficient in MS Project, MS Excel and other related tools.

Responsive, with a can-do attitude.

Ability to coordinate parallel tasks across multiple projects, demonstrating prioritization.

Ability to quickly adapt to a rapidly changing environment.

Ability to interpret and effectively execute upon a variety of communication channels.

EOE MFDV