Senior Director of Process Development

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: - Technical Leadership: Provide expert leadership across Process Development, overseeing both 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. - Analytical Strategy Development: Lead the development of analytical strategies within cross-functional teams to support clinical large molecule therapeutics programs. Establish phase-appropriate analytical development, characterization, and release strategies. - CMO/CTL Management: 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. - Material Management: Execute and manage material requests and receiving from CMO, partners, both domestic and international. - Cross-Functional Collaboration: 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. - Manufacturing and QC Partnership: Partner with manufacturing and QC to provide analytical development expertise for drug product release, characterization, and scaling. - CMC Analytical Data Management: 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. - Regulatory Submissions: Compile 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 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. - Experience: 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. Note: This is a senior leadership role, and the candidate must exhibit exceptional strategic vision, leadership skills, and a proven track record of successful process development in the biopharmaceutical industry. 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. SystImmune offers 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. Interested applicants should send their CV and cover letter to hrsystimmune.com J-18808-Ljbffr