Description: Your Impact:
The Analytical Development team plays an integral role alongside multiple cross functional groups. So someone highly collaborative who can communicate and influence ideas and strategic vision to key stakeholders will thrive here. In this role you will work alongside discovery groups, raw materials, gene therapy, process development, QC and Regulatory to commercialize cancer-fighting drugs. The AD team is very collaborative, open to knowledge transfers, and has each other’s back so you will have ample opportunity and support. The team itself works on multiple high-visibility projects at any time so there is room to grow both laterally and vertically. If you are passionate about science, about curing cancer and want to be part of a work family we want to hear from you.
Position Summary:
Poseida is seeking an exceptional candidate to join our Process Development Team. The Associate Director, Analytical Development will be responsible for development of analytical methods for cell therapy process and product development.
Responsibilities
These may include but are not limited to:

• Establish and lead the process analytical capabilities across process development for our CAR-T and gene therapy products.
• Recruit and manage a team of Analytical Process Scientists and Associates
• Establish methods for characterization of process and product and final product release for CAR-T product or other cell and gene therapy products
• Perform CRO assessments and lead the transfer of test methods to collaborators and CROs
• Drive the development of QC-friendly late-stage product release assays and new analytical methods to improve understanding of Poseida’s products
• Develop a reference standard program to support late-stage process
• Define specifications and perform lifecycle management of method by trending key parameters. Build an assay risk register to support the same
• Lead the development of analytical and functional testing methods for Poseida’s critical raw materials.
• Support Quality Control and Quality Assurance as necessary and participate in the technical assessment of Out of Specification and Non-Conforming investigations.
• Establish and maintain strong collaborative relationships with company’s R&D, and QC units
• Contribute to regulatory filings as requested by Regulatory

Requirements: Requirements, Knowledge, Skills and Abilities:

• PhD or Master’s degree in immunology, microbiology, molecular biology or other related discipline with a minimum of 10 years of industry experience in analytical development for cell and gene therapies (an equivalent combination of education and experience may be considered).
• Proven leadership experience with recruiting, managing and developing teams
• Industry experience with development of analytical methods, such as flow cytometry, qPCR, qRT-PCR, ELISA, cell-based potency assays, RNAseq, and gel electrophoresis.
• Experience developing assays for Quality Control testing of drug substance or drug product
• Ability to work in a fast-moving dynamic small company environment.
• Outstanding written and oral communication skills are essential
• Ability to present thoughts clearly and concisely to a wide variety of stakeholders including senior management
• High sense of integrity and professionalism and the ability to work well in a cross functional team environment
• May require travel up to 15%

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!

Job Type: Full-time

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