- Responsible for 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.
What You'll Bring
- 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.
- 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.
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.
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Our total rewards package that includes:
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits by country
- Zymelife health and wellness benefits
- Matching RRSP / 401K / Pension program
- Employee Share Purchase Program
- Employee Equity Program
- Paid time off to volunteer in your community
This role is not eligible for relocation or immigration support.
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.
