Position Summary:
Poseida is seeking a highly capable and talented Process Engineer to join our MSAT team to support process development of Poseida’s allogeneic cell therapy programs. She/he will focus on evaluation of new technologies to improve process performance that translate in increasing manufacturing success. The candidate will be expected to play an integral role in the planning and execution of process improvement and donor screening studies in support of Phase I-III clinical programs. The position will be based out of the newly created PD-MSAT group and given an opportunity to contribute to the development of overall CMC project strategies. The idea candidate will have extensive experience in cell culture, statistical process control methodologies, and analysis of large datasets. This position is located at our headquarters in San Diego, CA.
Responsibilities may include but are not limited to:
- Assist in design and drive execution of process optimization and process improvement studies in support of allogeneic programs
- Evaluate alternative technologies to create robust, reproducible, and scalable next generation manufacturing processes
- Maintenance of large-scale cell cultures in GRex, Wave, and stirred-tank bioreactors
- Critically review and analyze data, communicate results, present findings, and draft technical reports
- Assist in the development of standard operating procedures and technology transfer to internal or external manufacturers
- Perform experiment in support of manufacturing investigation and OOS
- Support Change Control initiatives and implement process changes in GMP environment
- Assist with regulatory packages and submission as needed
- Present ideas and data in cross-functional meetings
- Develop and maintain data tracking systems for clinical manufacturing process data and process development data, including collaborating with external partners
- Perform process monitoring using statistical process control methodologies and JMP statistical software
- Identify and troubleshoot out of trend results in manufacturing processes
- Perform data analysis supporting process investigations, validations, process transfers, and regulatory submissions
- Participate in a cross functional development team to advance CMC activities
Requirements, Knowledge, Skills and Abilities:
- Bachelor’s or Master’s degree in chemical engineering, bioengineering or related discipline with a 5+ years or relevant experience (an equivalent combination of education and experience may be considered). Master’s degree, preferred.
- Bioprocessing with a primary focus on the development, manufacture, distribution, and delivery of cell-based or biologic therapy products preferred
- Prior Cell Therapy experience and/or MSAT experience highly desired
- Basic understanding of cGMP requirements and ICH guidelines is preferred
- Excellent communication, presentation and facilitations skills required within a team setting
- Scientific acumen, problem solving and creative thinking, able to find process solution in a dynamic environment
- Proven ability to troubleshoot technical issues as they arise, and to work with automation instrumentation and software
- Ability to multitask, independently organize time, and plan specifics of work
- Proven ability to think outside the box, be creative and be comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Must be physically capable to lift 50 pounds
Process Engineer Salary Range: $99,000 to $120,000
The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience with the industry, education, geographic location, etc.
Who We Are and What We Do
Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients’ lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single treatment cures for patients in need. Our portfolio of product candidates is specifically designed to overcome the limitations of current generation cell and gene therapeutics.
At Poseida we put people first. Our team is passionate about improving patients’ lives through innovation. See what our team has to say about our culture:
“My favorite part about Poseida is all the people that I get to work with. Everyone is so passionate about what we’re doing here and there’s so much camaraderie. It feels like one big enthusiastic family.”
“My favorite part about working at Poseida is the amazing culture and working environment. Everybody is friendly, professional, collaborative, and has a remarkable can-do and positive attitude.”
As we advance our compelling pipeline, there are endless opportunities for impact and growth. We encourage you to apply today!
Recruitment Fraud Alert
Alert: Beware of Employment Scams
Poseida Therapeutics, Inc. has received reports of employment-related scams. These scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida’s Human Resources team. Be advised that Poseida Therapeutics does not extend unsolicited employment offers. Furthermore, Poseida Therapeutics does not request payment information or charge prospective employees with any fees during the recruitment process.
If you would like to pursue employment opportunities with Poseida Therapeutics, Inc., please visit our official careers website https://poseida.com/careers-culture/ or official Poseida Therapeutics LinkedIn page. Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent. You may report fraudulent job advertisements or contacts via our Contact Us page at https://poseida.com/contact-us/ and select the subject “Careers.” If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.