Director of Process Development

Redmond, WA

Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. 

Essential Duties and Responsibilities: 

  • Provide expert technical leadership across Process Development, leading both strategic and day-to-day activities across upstream and downstream process development of proteins.  

  • Oversee and manage process characterization and process validation studies, as well as technology transfer 

  • Lead the development of analytical strategy within a cross-functional team in support of clinical large molecules therapeutics programs. Establish phase-appropriate analytical development, characterization, and release strategies. 

  • Manage CMO/CTL relationships to ensure development and qualification of appropriate analytical methods to enable analytical development, release, and stability testing at CMOs/CTLs 

  • Work with protein engineering and immune-oncology (PE&IO) departments and cross-functional partners to build product understanding that serves as the foundation of the analytical strategy including establishing manufacturing feasibility, CQAs, and specifications throughout development. 

  • Partner with manufacturing and QC and provide analytical development expertise required to support drug product release, characterization, and scaling. 

  • Accountable for CMC analytical data– type, documentation, integrity, organization, and integration of datasets with cross functional partners for development purposes and regulatory submissions 

  • Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and GMP manufacturing 

  • Compilation of CMC sections for IND and BLA submissions 

  • Lead or participate in Project and CMC development teams, as required 

Qualifications: 

Education: 

  • Ph.D. in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or related field with at least 8+ years of laboratory experience in an industrial setting and with experience in CMC strategy and/or drug development. 

  • M.S. in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or related field with at least 10+ years of laboratory experience in an industrial setting. 

Experience: 

  • Experience in CMC strategy and/or drug development. 

  • Deep understanding of the design, development, optimization, and tech transfer of large molecule drug substance manufacturing processes. 

  • Expertise in developing/optimization/troubleshooting/execution/tech transfer of biophysical and/or analytical methods for the following: reduced and non-reduced peptide mapping, intact LCMS, released glycans, HPLC/UPLC (including but not limited to RP-HPLC, SEC, HIC and IEX), CE and iCE (cIEF) SDS-PAGE, ELISA and other general biochemical analyses/methods for protein/mAb analysis 

  • Expertise in quality attributes of therapeutic proteins with emphasis on chemical modifications including glycosylation, oxidation, deamidation, aspartate isomerization, and others 

  • Expertise with biophysical methods for protein/mAb characterization, such as MS, CD, DSC, MFI, and light scattering 

  • Ability to analyze and interpret complex data sets from multiple methodologies 

  • Experience/knowledge in bioprocess, formulation development and/or relevant analytical assay development. 

  • Strong independent problem-solving skills and ability to apply advanced innovative scientific approaches. 

  • Experience interfacing with GMP contract test laboratories and contract manufacturing organizations 

  • Experience with assessment of method robustness (assay performance characterization) required to support phase appropriate method qualification 

  • Familiarity with requirements for phase appropriate method validation and testing 

  • Demonstrated experience in cross-functional and functional leadership roles. Demonstrated collaboration skills working cross-functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively. 

  • Experience in drafting, reviewing, approving, and supporting regulatory filings and responses 

  • Proficient in ICH and FDA regulations and guidance.