Director of Analytical Strategy for Biologics

SystImmune, Inc.; Redmond (WA); On-site; USD 190,000 - 280,000; Full time

Benefits offered by this job

100% paid employee premiums (medical/d

Dental and vision coverage

401(k) plan with 50% company match up

15 PTO days per year

11 paid holidays

Job summary

SystImmune, Inc. is seeking a Director/Senior Director of Analytical to lead analytical strategy for early biologics development and GMP manufacturing. You will drive method development, validation, and tech transfer, partnering with PD/CMC teams and QC to ensure high-quality analytics across U.S. and China sites.

The role emphasizes leadership, regulatory support, and collaboration with cross-functional teams, including the Chengdu facility, to enable successful product release.

Qualifications

• Advanced degree in Analytical Chemistry, Biochemistry, or related field.
• 10+ years in industrial analytical development for biologics.
• Experience with method development, validation, and tech transfer.
• Proven ability to lead multidisciplinary teams and regulatory support.
• Mandarin reading/writing proficiency for Chengdu collaboration.

Responsibilities

• Lead Analytical teams and set strategy for method development and tech transfer.
• Collaborate with PD/CMC groups to define CQAs and specifications.
• Oversee external partner testing and data integration for regulatory submissions.
• Support IND/BLA filings with robust analytical data.
• Coordinate technology transfer and scale-up with sites in the U.S. and China.

Skills

Leadership

Analytical development

Cross-functional collaboration

Regulatory knowledge

Data analysis

Education

PhD preferred

Analytical Chemistry

Biochemistry

Job description

SystImmune, Inc. is seeking a Director/Senior Director of Analytical to lead analytical strategy for early biologics development and GMP manufacturing. You will drive method development, validation, and tech transfer, partnering with PD/CMC teams and QC to ensure high-quality analytics across U.S. and China sites.

The role emphasizes leadership, regulatory support, and collaboration with cross-functional teams, including the Chengdu facility, to enable successful product release.