Sr. Scientist, Process Analytical Development
San Diego, CA Process Development
Description

Your Impact:

The Analytical Development team interacts with many other departments so we are looking for someone highly collaborative who can define roadmaps and communicate ideas and vision to cross-functionally. In this role you will work alongside raw materials, gene therapy, process development, and CMC groups 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

We are seeking an experienced and motivated Sr. Scientist to join the Process Analytical Development team at Poseida Therapeutics. This position works with the Operations team to develop and/or optimize assays for DNA/RNA raw materials and drug product characterization and release. The Analytical Development Scientist participates in laboratory activities related to molecular biology and chromatography-based methods for the qualification/quantitation of nucleic acids, proteins, and drug/lipid metabolites. He/she is also involved in developing a roadmap for assay optimization and transfer to internal or external QC labs. Under minimal supervision, the role includes gap assessment, 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 analytical development, and is excited to take on new challenges in a fast-paced and dynamic environment. 


Responsibilities 

These may include but are not limited to:

  • Design and execute experiments to develop, qualify, and transfer methods for the testing and release of DNA/RNA products
  • Lead bioanalytical method development utilizing molecular biology and analytical chemistry tools for DNA and RNA products. 
  • Lead method development for bioassays and potency assays to characterize gene therapy candidates using AAV and nanoparticles.
  • Develop standard operating procedures, analytical test methods, qualification protocols, and stability strategies 
  • meeting the highest industry standard
  • Execute laboratory experiments in collaboration with more junior technical staff to generate high quality data by following best practices of assay and instrument operations
  • Analyze, document and present study outcomes and conclusions to key stakeholders
  • Lead method and analytical technology transfers from Poseida to contract testing labs as appropriate
  • Provide technical and scientific leadership relating to support of analytical operations on troubleshooting in QC and long-term strategic optimization
  • Provide in depth and hands on technical expertise to aggressively progress the company’s portfolio
  • Author assay development and qualification reports and regulatory documents (pre-INDs, and INDs). 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
Requirements

Requirements, Knowledge, Skills and Abilities

  • PhD degree in a relevant scientific discipline e.g. molecular biology, immunology, analytical chemistry, pharmaceutical science, biophysics etc. with 5 plus years of relevant industry experience in analytical development, technology transfers and method lifecycle management (a combination of education and experience may be considered)
  • In depth experience with analytical method development for characterization and release with experience in cGMP requirements and testing in clinical and commercial QC.
  • Proven leadership in method optimization and remediation, CMC tech-transfer, analytical control strategies and method qualification/validation
  • Ability to interpret and apply ICH guidance, cGMP, USP, regulatory requirements and industry best practices
  • Extensive experience in all aspects for the technical transfer of analytical methods between facilities is required
  • Experience in analytical techniques such as Flow cytometry, PCRs, gel electrophoresis, fragment analyzer, sequencing, LC-MS/MS, HPLC/UPLC, light scattering (DLS, MALS, NTA), and other relevant molecular biology and analytical chemistry methods for characterizing the physiochemical properties of nucleic acids
  • Expertise in the design, development, optimization and qualification of mechanism-of-action indicating potency assays
  • Proficiency in Design of Experiments (DoE) and data analysis a plus
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
  • Self-motivated, detail-oriented, and willing to accept temporary 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
  • Excellent interpersonal, verbal and written communication skills are essential
  • Attention to safety, good laboratory practice, and good documentation practice

  

Salary Range: $122,850 to $179,025

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!