Director, Process Development/CMC - Small Molecules

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.

Position Overview:

The Director of Process Development/CMC -Small Molecules 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. The Director will oversee the strategic and operational aspects of small molecule process development, ensuring that processes are optimized for both local and global needs. Proficiency in reading and writing Mandarin Chinese is required to effectively collaborate with the Chengdu facility and global partners.

Essential Duties and Responsibilities: 

- Technical Leadership:

• Provide expert 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.

-  Collaboration with Chengdu Facility:

• 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.

-  Global Partner Interaction:

• 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.

-  Analytical Strategy 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.

-  Manufacturing and QC Partnership:

• 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.

- Regulatory Submissions:

• Compile and review CMC sections for IND, BLA, and other regulatory submissions.
• Participate in Project and CMC development teams as required.

Qualifications:

- Education:

• 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.

- Experience:

• 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.
  

The hiring pay range for this position is $220,000 - $280,000 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 [email protected]

Are you interested in this position?

Apply Now