Job Req ID:  587
Location: 

Seattle, WA, USA

Additional Locations:  N/A
Department: 

Senior Scientist, Upstream Process Development

Company Description
Zymeworks is a publicly listed (NASDAQ: ZYME) clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, biospecific 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. 

 

Why Work With Us

Nothing is more critical to our success than the quality of our team.   The work we do is meaningful and impactful - we care about each other as well as the patients we serve.  We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.  

 

We have an exciting opportunity for an Upstream Scientist or 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.

 

Zymeworks is proudly headquartered in our brand new, net-zero facility located in the vibrant Main St biotech hub of Vancouver, BC, with operations in Seattle, WA, San Francisco, CA and Dublin, Ireland.  We offer a hybrid work environment with most team members working in-office three days per week. 

 

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 Experience

  • A PhD, MSc, or BSc, in Chemical/Biochemical Engineering, Biological Sciences or related disciplines with at least 4 years (2 years for PhD) of industrial experience for Scientist position, or 6 years (4 years for PhD) of industrial experience for Sr. Scientist position.  The experience needs to be in the upstream process development with mammalian cell culture.
  • The job title of Scientist or Sr. Scientist will be determined based on the years of experience and the relevance of experience to the job.
  • 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.

 

Total Rewards

We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth.  We regularly benchmark our compensation against leading biotechnology companies in our geographies.  

 

Our team enjoys: 

  • Industry leading vacation and paid time off
  • Excellent health and wellness benefits
  • Zymelife health and wellness benefits
  • Paid time off to volunteer in your community
  • Matching RRSP / 401K program
  • Employee Share Purchase Program
  • Employee Equity Program

 

All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability. 

 

NOTE TO AGENCIES:  Zymeworks values our relationships with our recruiting partners.  We only accept resumes from those partners who have been contracted with us.  Zymeworks is not responsible for any fees related to resumes that are unsolicited or are received without contract.  

Date:  Jan 19, 2023