Your Impact
Our talented and collaborative analytical development team is seeking a highly motivated individual who possesses a strong work ethic, team-oriented attitude, and a passion for delivering next-generation cell and gene therapies to patients. In this role you will be working with team members to develop and optimize analytical assays to characterize Poseida’s cell and gene therapy products. You will have a direct impact in developing and optimizing new and existing analytical assays to help better characterize and understand Poseida’s drug products to help ensure patient safety and deliver the highest quality therapies.
Position Summary:
We are seeking an experienced and motivated Scientist II to join the Analytical Development team at Poseida Therapeutics. This position works with the Technical Operations team to develop and/or optimize analytical assays for cell and gene product characterization, release, and stability. The Scientist II participates in laboratory activities to support process development, evaluate and develop new analytical test methods, and perform product characterization for CAR-T cell products as well as gene therapy products. He/she is also involved in assay optimization, standardization, qualification, and transfer to internal or external QC labs. Under minimal supervision, the role includes performing assay development experiments, carefully documenting methods and materials, writing SOPs/reports/CMC sections of IND, and communicating findings. The ideal candidate has a proven track record of innovation, demonstrated skill set and knowledge in process and analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment.
Responsibilities may include but are not limited to:
- Develop or adapt analytical methods for cell therapy product release and characterization by designing and executing studies via design of experiment (DoE).
- Develop or adapt analytical methods for gene therapy product release and characterization by designing and executing studies via design of experiment (DoE).
- Design and execute exploratory experiments to better understand and define CQAs and optimize current analytical methods.
- Make recommendations to key stakeholders at Poseida.
- Independently research, plan and execute experiments and analyze data to determine next course of action and make recommendations to internal and inter departmental audiences.
- Perform risk and gap assessments for analytical methods and aim to enhance compliance and robustness.
- Execute routine laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations.
- Perform data analysis and document study outcomes and conclusions, summarize and present to key stakeholders.
- Design, execute, and approve method development, transfer, and qualification in support of process development, product characterization, product release and stability.
- Lead lifecycle management of analytical assays by trending the data assigning appropriate controls.
- Author assay development and qualification reports and regulatory documents. Ensure adherence to high technical standards and compliance with applicable regulatory guidelines in the generation of analytical data to support regulatory filings.
- Work with a cross-functional team to advance development of cell therapy products.
- Support training of junior Research Associates or other team members, as needed.
Requirements, Knowledge, Skills and Abilities:
- Ph.D. degree in a relevant scientific discipline (e.g., Immunology, Molecular Biology Biochemistry, or related field) with 2+ years of industry experience in analytical development, QC, technology transfer and method lifecycle management (a combination of education and experience may be considered).
- Expertise in cell-based assay development, potency assay development, analytical method development and cGMP guidance, preferably in the gene and cell therapy industry
- Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
- Demonstrated proficiency in experimental design, data analysis, control charts and capability assessments using Design of Experiments (DoE)
- In depth experience in analytical techniques such as Flow cytometry, qPCR, ddPCR, Nanodrop, Fragment Analyzer, ELISA, Isoplexis, Nanostring, metabolic analysis, HPLC and potency assays
- Experience with the development and optimization of NGS assay protocols a plus
- Ability to interpret and apply ICH guidance, cGMP, USP, regulatory requirements and industry best practices for analytical method development, technology transfer, method qualification/validation and process development.
- Development, transfer, and qualification of cell-based assays for QC release testing and product characterization
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities.
- Excellent interpersonal, verbal and written communication skills are essential.
- Self-motivated, detail-oriented, and willing to accept responsibilities outside of initial job description.
- Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams.
- Ability to think critically and demonstrated troubleshooting and problem-solving skills.
- Attention to safety, good laboratory practice, and good documentation practice.
- Experience with statistical programming or software (e.g., R) a plus.
Scientist II, Analytical Development Salary Range: $113,000 to $144,410 annually
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.
