Senior Scientist, Purification Process Development
$116,250–$178,250 year
HybridBellevue, Washington, United States
Job Summary
Develop scalable purification processes for GMP manufacturing and characterize late-stage processes to define control strategies and perform risk analysis. Coordinate with research groups to evaluate manufacturability, collaborate on establishing critical quality attributes, and maintain downstream databases for development data and equipment. Author technical protocols, batch records, SOPs, and regulatory filings including IND, IMPD, and BLA sections while reviewing executed batch documentation for release. Serve as subject matter expert for process development experiments and GMP investigations, ensuring successful scale-up with external CDMO partners and DS supply availability. Maintain positive relationships with cross-functional teams and external stakeholders to communicate downstream progress and update manufacturing performance.
Required Qualifications
- PhD, MSc, or BSc, in Chemical/Biochemical Engineering, Biological Sciences or related disciplines
- at least 8 years (5+ years for PhD) of industrial experience in downstream process development
- some GMP manufacturing experience
- Experienced in downstream process development, characterization, scale-up and manufacturing in the cGMP environment
- Experience working with contract manufacturing organizations
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
- Ability to establish and maintain effective working relationships
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment
- Excellent oral and written communication skills, including the ability to integrate complex data to produce clear and accurate reports and presentations
- Strong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use
- Working knowledge of regulatory guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development
- Proficiency with cGMP and ICH guidelines
- Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development
- Experience working in a GMP manufacturing environment
- This role will be located in Bellevue, WA and is hybrid with a minimum of 3 days per week onsite
- This role is not eligible for relocation or immigration support
Desired Qualifications
- Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus
- Experience working in a GMP manufacturing environment a plus
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