Senior Scientist, Purification Process Development

Zymeworks Inc.•Bellevue, WA

7d•$116,250 - $178,250

About The Position

This role is responsible for developing robust early-phase purification processes suitable for GMP manufacturing. The Senior Scientist will coordinate with research groups, collaborate with analytical development, and maintain a downstream database. They will also serve as a subject matter expert for process development experiments, GMP manufacturing, and investigations. Responsibilities include late-stage purification process characterization, risk analysis, defining control strategies, and process qualification. Collaboration with external CDMO partners for scale-up and technology transfer is crucial. The role involves reviewing executed batch documentation, authoring regulatory filings, and providing technical oversight of GMP manufacturing operations. Effective communication with managers, peers, and external partners is essential for updating on progress, presenting data, and managing manufacturing performance. Establishing and maintaining positive working relationships are key.

Requirements

A PhD, MSc, or BSc, in Chemical/Biochemical Engineering, Biological Sciences or related disciplines with at least 8 years (5+ years for PhD) of industrial experience in downstream process development with 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.

Nice To Haves

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.

Responsibilities

Developing a robust early phase process specifically related to all purification operations.
Develop scalable purification processes suitable for GMP manufacturing.
Coordinate with research group on upcoming projects and evaluate manufacturability.
Collaborate with analytical development to establish critical quality attributes (CQAs) and monitor process performance.
Maintain downstream database for purification development data, reports, purification related raw materials, equipment, and process history, and analyze downstream data using statistical analysis or other methods.
Author and review process development reports, technical protocols, batch records, SOPs, risk assessments, and technology transfer documentation.
Serve as subject matter expert to plan, review, approve, monitor, and analyze process development experiments, GMP manufacturing and investigations.
Responsible for late-stage purification process characterization; performing risk analysis, defining control strategy and process qualification.
Collaboration with external CDMO partners to ensure successful scale-up and technology transfer to GMP facility.
Review executed batch documentation in support of batch release.
Author relevant sections of regulatory filings, including IND, IMPD and sections of BLA, and provide responses to health authorities as required.
Provide technical oversight and support of GMP manufacturing operations.
Effectively communicate with managers, peers, and external partners, to comprehend downstream progress, present process data and trending results, and update manufacturing performance.
Establish and maintain positive working relationships with peers, management and external partners.
Works closely with all internal and external resources to ensure DS supply availability.