Process Development Specialist

The Process Development Specialist will collaborate with the R&D team and external partners to support cell therapy manufacturing process development and characterization and process optimization for Drug Product preparation at the clinical site.  The Process Development Specialist will lead technology transfer of manufacturing processes and will support development of scaled-down manufacturing models to support process characterization and optimization for new cell therapy candidates.   Duties will include writing new manufacturing documents and coordinating the revision, review, and approval of manufacturing-related SOPs, validation protocols/reports and other GMP documents that are necessary for ensuring compliance with applicable U.S. and global standards. 

Responsibilities

• Work with the R&D team and external partners to develop manufacturing processes for expansion and differentiation of pluripotent stem cells.  Perform technology transfer of manufacturing processes to internal and external cGMP manufacturing teams.
• Develop and optimize cell culture processes for expanding and differentiating PSCs in both 2D and 3D (bioreactor) systems.  Translate small-scale processes into larger, scalable manufacturing processes, ensuring quality and reproducibility. 
• Prepare user specifications for equipment to support cGMP manufacturing.  Procure equipment and support qualification of equipment including writing IQ/OQ protocols and working with the team to execute qualification studies and write reports.   Prepare SOPs for equipment operation, maintenance, and calibration. 
• Work with Quality Assurance to prepare documentation to support cGMP manufacturing including raw material specification (RM), manufacturing procedures (MP) and related Standard Operating Procedures (SOPs).
• Participate in required cGMP training activities including training on required SOPs and manufacturing procedures. 
• Prepare protocols for aseptic process qualification studies and process engineering runs.  Work with the manufacturing team to execute qualification/validation studies and prepare documentation and reports for review by Quality Assurance and manufacturing staff. 
• Work with Analytical Development/Quality Control to develop in-process testing plans.  Assist in the development of appropriate analytical methods as needed. 
• Support Quality Assurance documentation functions for cGMP production, in-process testing, and release testing of cell therapies.   Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed. 

·       BS in Biology, Biochemistry, Bioengineering, or related field

·       5+ years of experience in cell therapy manufacturing or process development required.  Experience in PSC culture and differentiation techniques in both 2D and 3D (bioreactor) systems is required.

·       Experience in process development with hands-on experience in cell therapy production and aseptic manufacturing techniques is required.

·       Experience in writing SOPs and validation protocols for equipment and manufacturing processes is highly desirable

·       Experience with Good Documentation Practices is required.  Experience reviewing cGMP documentation is highly desirable.

·       Experience with flow cytometry including the following responsibilities operating and maintaining flow cytometers, preparing samples, performing data acquisition and analysis, and potentially training others

·       Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required.

·       Expertise using MS WORD, Excel, and database programs.  Experience in working with an eQMS and/or LIMS is also desirable. 

Kenai Therapeutics is advancing off-the-shelf dopamine neuron replacement therapies as a disease-modifying and potentially curative treatment for neurological disorders. Our next-generation, gene-modified iPSC platform leverages a novel approach to treating central nervous system conditions, such as Parkinson’s disease, by replacing neurons that are lost due to degenerative neurologic disorders and delivering therapeutic proteins. RNDP-001, our lead cell therapy candidate, is an iPSC-derived dopamine progenitor for the treatment of both idiopathic and inherited forms of Parkinson’s disease, and has displayed superior survival, innervation, and behavioral rescue in preclinical models of Parkinson’s diseases. Kenai also has two additional gene-modified programs in discovery phase for the treatment of mild to severe rapid progressing Parkinson’s disease and young onset Parkinson’s disease.

Kenai currently occupies state-of-the-art labs in San Diego and is hiring new members for that team. This is an excellent opportunity for a talented, highly motivated individual to make significant contributions to the development of next-generation therapies to treat devastating neurological disorders. 

 How to Apply

Interested candidates are invited to submit their resume and cover letter to [[email protected]] with the subject line "Process Development Specialist Application – [Your Name]."

Kenai Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

We look forward to reviewing your application and exploring how you can contribute to our exciting journey in advancing cutting-edge cell therapy treatments for degenerative neurological diseases.