Job Description

Why Work for Us? Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care We come from many countries, cultures, races, ethnicities, abilities and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs. We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance. Company Description Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworks’ suite of complementary therapeutic platforms and its fully-integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly-differentiated product candidates. We have an exciting opportunity for an Upstream Scientist/Sr. Scientist to join Process Development (PD) group at Zymeworks. The Upstream PD Scientist of is responsible for scientific and technical oversight of Zymeworks’ biologics upstream manufacturing process, including mammalian cell line development, cell banking, cell culture process development and scale-up, for both early- and late-stage projects. The candidate will play a Subject-Matter Expert (SME) role to support external network of biologics drug substance manufacturing, including upstream raw material tracking, cell banking, upstream document review, process data management, trending of upstream and primary recovery manufacturing performance, and future process improvement.

This position will report to the Director/Associate Director of Upstream Development in PD and will be based in Vancouver BC or Remote (Canada). As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such. Key Responsibilities

• 
  Oversee the late-stage upstream process, from cell line development, cell bank management, to primary recovery, for the manufacturing of biologic therapeutics using mammalian cell culture system with the fed-batch or perfusion mode.
• Perform as the upstream SME for the manufacturing of biological therapeutics at CDMOs, to support IND and BLA filings.
• Visit CMO sites when needed to inspect manufacturing readiness and process performance, perform PIP and troubleshooting duties if necessary.
• Provide technical support for upstream process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.
• Work collaboratively with peers in MS&T, Analytical Development, CMC management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers to achieve corporate objectives.
• Maintain upstream database for cell line, cell banks, and all culture related raw materials, equipment, and process history, and analyze upstream data using statistical analysis or other methods.
• Effectively communicate with managers, peers, and external partners, to comprehend upstream progress, present process data and trending results, and update manufacturing performance.
• Draft and review technical and regulatory documents for upstream development and manufacturing activities, to support regulatory filing and inspection.

Qualifications and Education

• 
  A PhD, MSc, or BSc, in Chemical/Biochemical Engineering, Biological Sciences or related disciplines with at least 5 years (3 years for PhD) of industrial experience in upstream process development with mammalian cells.
• Strong interpersonal and team skills, including the ability to work collaboratively in a fast-paced cross-functional environment.
• Strong data management skills with good understanding of statistical analysis.
• Excellent oral and written communication skills, including the ability to integrate complex data to produce clear and accurate reports and presentations.
• Excellent knowledge of upstream process development, characterization, scale-up and manufacturing in the cGMP environment.

NOTE TO EMPLOYMENT AGENCIES: Zymeworks values our relationships with our Recruitment Partners. We will only accept resumes from those partners whom have been contracted by a member of our Human Resources team to collaborate with us. Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract. #LI-PT1