Director of Process Development and Manufacturing

6 days ago

Seattle, Washington, United States SystImmune Full time
Job Title: Director of Process Development and Manufacturing

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). We are seeking a highly experienced Director of Process Development and Manufacturing to join our team in Redmond, WA.

Job Summary:

The Director of Process Development and Manufacturing will play a key role in bridging SystImmune's operations between the U.S. and China. This role involves close collaboration with the manufacturing facility and R&D center in Chengdu, China, as well as engaging with global partners in drug co-development.

Key Responsibilities:
  • Provide technical leadership in the process development of small molecules, overseeing both strategic and day-to-day activities.
  • Lead and guide process characterization, validation studies, and technology transfer initiatives for small molecule therapeutics, with a focus on collaboration between Redmond and Chengdu teams.
  • Work closely with the manufacturing facility and R&D center in Chengdu to ensure alignment in process development, scale-up, and manufacturing activities.
  • Facilitate technology transfer and ensure consistency between sites, maintaining high-quality standards and regulatory compliance.
  • Identify and manage processes, and ensure successful technology transfer for scale-up and GMP manufacturing, particularly between the U.S. and China.
  • Execute and manage material requests and receiving from partners, and the Chengdu facility, ensuring timely and compliant delivery.
  • Engage with global partners in drug co-development to support joint ventures, ensuring successful integration of process development strategies.
  • Coordinate with partners to align on manufacturing feasibility, critical quality attributes (CQAs), and specifications throughout development.
  • Develop and implement analytical strategies to support antibody and ADC development, including phase-appropriate analytical development, characterization, and release strategies.
  • Collaborate with cross-functional teams to establish critical quality attributes (CQAs) and specifications.
  • Oversee analytical development, release, and stability testing at external partners.
  • Ensure the integrity, organization, and integration of CMC analytical datasets, supporting development and regulatory submissions.
  • Partner with manufacturing and QC teams in both Redmond and Chengdu to ensure successful product release, characterization, and scaling.
  • Provide technical support and troubleshooting during production campaigns across global sites.
  • Compile and review CMC sections for IND, BLA, and other regulatory submissions.
  • Participate in Project and CMC development teams as required.
Requirements:
  • Ph.D. in chemistry, pharmaceutical sciences, or a related field with at least 10+ years of laboratory experience in an industrial setting.
  • M.S. in a relevant field with at least 12+ years of laboratory experience in an industrial setting.
  • Extensive experience in CMC strategy and small molecule drug development.
  • Deep understanding of the design, development, optimization, and tech transfer of small molecule drug substance manufacturing processes.
  • Expertise in developing, optimizing, troubleshooting, and tech transferring analytical methods for small molecules.
  • Proficient in analyzing and interpreting complex datasets from multiple methodologies.
  • Significant experience interfacing with GMP contract test laboratories and contract manufacturing organizations.
  • Expertise in method robustness assessment, validation, and testing.
  • Demonstrated experience in cross-functional and functional leadership roles with strong collaboration and stakeholder relationship management skills.
  • Rich experience in accepting and passing on-site inspections conducted by FDA.
  • Familiar with EHS requirements relevant to the manufacturing processes of small molecule drug substances.
  • Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses.
  • Comprehensive knowledge of ICH and FDA regulations and guidance for small molecules.
  • Language Skills: Proficiency in reading and writing Mandarin Chinese is required to effectively collaborate with the Chengdu facility and global partners.
What We Offer:

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

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