Director, Analytical Development
San Diego, CA Process Development
Description

Your Impact:

The Analytical Development team plays an integral role alongside multiple cross functional groups. 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, Cell therapy, early process development, QC and Regulatory to commercialize curative gene delivery and editing drugs and cell therapy products. The Analytical Development team is responsible for assay development and optimization for both raw material and final cell/gene therapy product. Hence, Analytical team demands a highly collaborative team and leader who is open to knowledge transfer and collaboration with all dependent functions 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 rare diseases 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 Director, Analytical Development will be responsible for leading the development of analytical methods for Poseida’s gene therapy products. 


Responsibilities may include but are not limited to:

  • Establish and lead the analytical capabilities across for our CAR-T and gene therapy products.
  • Recruit and manage a team of Analytical Process Scientists and Associates
  • Representing Analytical Development on cross functional Cell and Gene therapy CMC development teams.
  • Establish methods for characterization of process and product, and final product release for novel gene delivery and editing therapies, including mRNA, sgRNA, lipid nanoparticles (LNP), adeno-associated virus (AAV), 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 product release assays and new analytical methods to improve understanding of Poseida’s products.
  • Define specifications and perform lifecycle management of method by trending key parameters.
  • Lead the development of analytical and functional testing methods for Poseida’s critical raw materials cell and gene therapy programs.
  • Support internal and external 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 (e.g., early process development, Manufacturing Science and Technology) and Quality Control units, as well as external third-party testing organizations.
  • Author and review regulatory submissions and filings as requested by Regulatory.
Requirements

Requirements, Knowledge, Skills, and Abilities:

  • Ph.D. in immunology, microbiology, molecular biology, or other related scientific discipline with 12+ 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 substances or drug products.
  • Expertise in all stages of the method development lifecycle from method feasibility to validation.
  • 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%.


Director, Analytical Development Salary Range: $178,000 to $220,000

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.


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.