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Senior Director of Process Development

2 months ago

Redmond, Washington, United States SystImmune Full time
{"title": "Senior Director of Process Development", "description": "Job Summary

Systimmune Inc. is a bio-pharmaceutical company focused on developing novel therapeutic multi-specific antibodies and antibody-drug conjugates (ADCs) for cancer treatment. We are seeking a Senior Director of Process Development to lead our process development efforts and oversee the development and qualification of analytical methods.

Key Responsibilities
  • Provide technical leadership across process development, overseeing strategic and day-to-day activities in upstream and downstream process development of proteins.
  • Lead and guide process characterization, validation studies, and technology transfer initiatives.
  • Develop and implement analytical strategies within cross-functional teams to support clinical large molecule therapeutics programs.
  • Establish phase-appropriate analytical development, characterization, and release strategies.
  • Manage relationships with CMOs/CTLs to ensure the development and qualification of appropriate analytical methods.
  • Oversee analytical development, release, and stability testing at CMOs/CTLs.
  • Execute and manage material requests and receiving from CMO, partners, both domestic and international.
  • Collaborate with protein engineering, immune-oncology (PE&IO) departments, and cross-functional partners to build a robust product understanding.
  • Establish manufacturing feasibility, critical quality attributes (CQAs), and specifications throughout development.
  • Partner with manufacturing and QC to provide analytical development expertise for drug product release, characterization, and scaling.
  • Accountable for the type, documentation, integrity, organization, and integration of CMC analytical datasets with cross-functional partners for development and regulatory submissions.
  • Identify appropriate CMOs, manage contracts, and oversee technology transfer to support scale-up and GMP manufacturing.
  • Compile CMC sections for IND and BLA submissions.
Requirements
  • Ph.D. in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or a related field with at least 12+ years of laboratory experience in an industrial setting and experience in CMC strategy and/or drug development leadership.
  • M.S. in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or a related field with at least 15+ years of laboratory experience in an industrial setting.
  • Extensive experience in CMC strategy and antibody-based drug development.
  • Deep understanding of the design, development, optimization, and tech transfer of large molecule drug substance manufacturing processes.
  • Expertise in developing, optimizing, troubleshooting, and tech transferring biophysical and analytical methods for proteins/mAbs.
  • Profound knowledge of quality attributes of therapeutic proteins, particularly chemical modifications such as glycosylation, oxidation, deamidation, aspartate isomerization, etc.
  • Proficient in 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 in bioprocess, formulation development, and relevant analytical assay development.
  • Strong independent problem-solving skills with ability to apply advanced innovative scientific approaches.
  • Significant experience interfacing with GMP contract test laboratories and contract manufacturing organizations.
  • Expertise in method robustness assessment and phase-appropriate method validation and testing.
  • Demonstrated experience in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills.
  • Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses.
  • Comprehensive knowledge of ICH and FDA regulations and guidance.
About Systimmune

Systimmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

We offer a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

Systimmune is an Equal Opportunity Employer.

"}