Principal Scientist, Analytical Development

Description

Your Impact

Our talented and collaborative Genetics Medicines team is seeking a highly motivated hands-on analytical leader to join our collaborative team. In this role, you will have the opportunity to drive the selection and development of analytical separations and biophysical techniques while working across organizational boundaries with partners spanning from R&D to QC.  You will directly impact by developing or improving the analytical understanding of Poseida’s novel genetic medicines products technology selection as you establish new release and characterization methods. 

Position Summary

Poseida seeks a seasoned Principal Scientist of Analytical Development to join our Genetic Medicines team. This individual will leverage their strong organizational, communication, and strategic leadership skills to drive the development of analytical separations and biophysical analysis methods.  This role will be responsible for the full lifecycle development of release and characterization test methods for Poseida’s advanced therapy modalities, including lipids, pDNA, sgRNA, mRNA, and lipid nanoparticles (LNP).  

Responsibilities 

These may include but are not limited to:

• Lead the development of analytical chemistry and biophysical analytical capabilities for Poseida’s advanced therapeutic products.
• Establish methods for characterization of process intermediates and final product release for novel gene delivery and editing modalities, including pDNA, mRNA, sgRNA, lipids, LNP, and adeno-associated virus (AAV).
• Lead method development, transfer, qualification, and validation of QC-friendly product release methods.
• Support the definition and justification of phase-appropriate release specifications.
• Represent Analytical Development on cross-functional gene therapy CMC development teams.
• Perform assessments of contract testing labs (CTL) and lead the transfer of test methods to collaborators and CTLs.
• 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 internal R&D and Quality Control teams, as well as external third-party testing organizations.
• Recruit and manage a team of analytical scientists and associates. 
• Author and review regulatory submissions and filings.

Requirements

 Requirements, Knowledge, Skills and Abilities

• Ph.D. in biochemistry, biophysics, chemistry or other related scientific discipline with 8+ years of industry experience in analytical development for biologics and gene therapies (an equivalent combination of education and experience may be considered).
• Demonstrated expertise encompassing all stages of the method development lifecycle for clinical and commercial products including method development, optimization, qualification, and validation.
• Expert knowledge of analytical chemistry and extensive hands-on development experience in chromatography (HPLC/UPLC/2D-LC) and electrophoretic techniques (Gel/CGE/CE,) for complex modalities such as proteins, nucleic acids, lipid, LNP, and/or AAV.
• Experience working with other biophysical analytical techniques such as LC/MS, SEC-MALS, Spectroscopy, DLS, CryoEM, and AUC. 
• Experience developing characterization and release assays for pDNA, mRNA, sgRNA, LNP, lipids, and/or AAV is strongly preferred.
• Experience or familiarity with sequencing techniques is desirable, such as Sanger, NGS, and RNAseq.
• Demonstrates knowledge of cGMP compliance, regulatory agency requirements and ICH compliance.
• Proven leadership experience with recruiting, managing and developing teams.
• 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%.

Principal Scientist, Analytical Development Salary Range: $144,000 to $180,000 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 propri