Process Development Scientist, Early Process Development
San Diego, United States
Job Description
This position is highly cross-functional and will work closely with R&D, Manufacturing Science and Technology, Analytical Development and Manufacturing teams to develop, optimize, and integrate next generation processes and technologies for cell therapy manufacturing. The individual will focus on improving process understanding and performance with the intent to increase manufacturing success. She/he will be responsible for cell processing, process engineering scale-up/scale-down, bioreactor process parameters, assessment of novel technologies, cryopreservation, and equipment maintenance. Under minimal supervision, she/he will be expected to design and perform experiments, organize and carefully document results, analyze and interpret data, and communicate findings. The individual will be expected to complete scientific and technical tasks on aggressive timelines. This position requires exceptional attention to detail, excellent communication skills, and the desire to develop junior team members.
Responsibilities
These may include but are not limited to:
- Design and drive process optimization studies in support of allogeneic CAR-T programs. Experience with Design of Experiment (DoE) a plus
- Critically evaluate new technologies and process automation to create robust, reproducible, and scalable next generation manufacturing processes. Stay current with relevant literature
- Assess new platform suitability across cell therapy programs
- Prepare and conduct training for process improvements and technology transfers
- Contemporaneously review and analyze data, communicate results, and draft technical reports
- Present ideas and data in team and cross-functional meetings. Be an active participant and intellectual leader
- Work closely with MSAT in support of change control initiatives and manufacturing investigations
- Assist in the development of standard operating procedures and technology transfer documentation to internal or external manufacturing
- Document laboratory procedures and experiments with great attention to detail in laboratory notebooks
- Provide leadership to more junior team members
Requirements, Knowledge, Skills and Abilities:
- Ph.D. in Immunology, cancer biology, or engineering science with 0-2 years of related industry experience (an equivalent of education and relevant experience in pharmaceutical manufacturing, research or industrial laboratory may be considered)
- Experience with managing junior team members
- Demonstrated excellent aseptic technique and suspension cell culture proficiency
- Experience with cell separation, cell processing, cell culture, and manipulation of primary mammalian cells
- Understand manufacturing needs and ability to adapt as required
- Self-motivated with ability to work on multiple projects at once
- Demonstrated ability to troubleshoot, optimize and solve challenging research problems
- Must be an organized and detail-oriented person with excellent verbal and written communications skills
- Technical writing and protocol/report writing a plus
- Experience in statistical analysis using JMP or equivalent
- Adequate understanding and knowledge of immunology and CAR-T cell therapy
- Experience in several of the following areas preferred: CAR-T cell therapy, process development, process characterization, scale-up, cGMP clinical manufacturing, automation, Design of Experiment (DOE)
Process Development Scientist Salary Range: $98,000 to $114,000
The final salary 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.
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Career Focus: Biology, Engineer, Immunology
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