Upstream Process Development Jobs in Bothell, 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.

The Director/ Senior Director of Analytical will lead the Analytical teams, working collaboratively with the Director of Process Development, Head of Cell Science in Redmond, WA and CMC leads in Chengdu. This role is responsible for driving analytical strategy, method development, and release assay designs to support early-stage biologics development and GMP manufacturing. The role is responsible for integration of analytical workflows with upstream and downstream processes and is accountable for analytical method transfer to the company's GMP manufacturing site in China.

Key Responsibilities

1. Leadership & Strategy:
   • Manage and mentor Analytical teams.
   • Develop strategies for analytical method development, validation, and tech transfer.
   • Drive innovation in integrated discovery and manufacturability for novel biologics.
2. 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 analytical datasets, supporting development and regulatory submissions.
   • Support regulatory filings (e.g., IND, BLA) with robust analytical data and interpretation.
   • Partner with QC teams in Chengdu to ensure successful product release, characterization, and scaling.
3. Collaboration & Integration:
   • Partner closely with the Director of Process Development for PAT workflows.
   • Participate in cross-functional PD/CMC working groups to meet project milestones.
   • 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.

Qualifications

• Advanced degree (PhD preferred) in Analytical Chemistry, Biochemistry, or related field.
• At least 10+ years of laboratory experience in an industrial setting. Extensive experience in analytical development for biologics, including method validation and tech transfer.
• Proven experience supporting co-development alliances and global technology transfers.
• Strong leadership skills with a proven track record of managing multidisciplinary teams.
• Knowledge of GMP regulations and global regulatory expectations.

Experience:

• Extensive experience antibody or ADC drug development.
• Deep understanding of the design, development, optimization, and tech transfer of antibody or ADC manufacturing processes.
• Expertise in developing, optimizing, troubleshooting, and tech transferring analytical methods for antibodies or ADCs.
• Proficient in analyzing and interpreting complex datasets from multiple methodologies..
• 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.
• Proficient in drafting, reviewing, approving, and supporting regulatory filings and responses.
• Comprehensive knowledge of ICH and FDA regulations and guidance for biologics and ADCs.
• Language Skills: Proficiency in reading and writing Mandarin Chinese is required to effectively collaborate with the Chengdu facility and global partners.

The expected base salary range for this position is $190,000 - $280,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
 
SystImmune is a leading and 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.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

Powered by JazzHR

X7cHDNLTSo