Senior 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:

- 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.

- Technology Transfer:

• 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.

The hiring pay range for this position is $260,000 - $290,000 per year based on skills, education, and experience relevant to the role.

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 hr@systimmune.com