Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation multifunctional biotherapeutics, initially focused on the treatment of cancer. Zymeworksâ 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.
About the Position
The Associate Director, Analytical Development is accountable for all phases of analytical method development and product characterization as well as supporting the GMP manufacture of novel therapeutic antibodies and antibody drug conjugates. This position is responsible for leading the analytical activities and supporting manufacturing collaboration with contract manufacturing organizations and quality control groups. This will include visits to development and manufacturing sites as necessitated by the ongoing activities. Cross-functional collaboration with other departments, including project management, clinical, quality assurance and regulatory will be routinely required.
Key Responsibilities
- Contributes their expertise to the strategic planning, direction and support of analytical method development and biochemical characterization for all phases of process development from first in human to late clinical phase and commercial filings.
- Collaborates within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for biotherapeutics including ADCs.
- Supports the method development, qualification and validation of methods for biotherapeutics.
- Participates in the development of RFPâs to solicit project specific bids from CMOs/CROs.
- Develops SOWs defining work to be performed and provide subsequent oversight of analytical development activities conducted at the CMO/CRO.
- Authors technical documents and deliver presentations to technical and project groups.
- Contributes to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
- Designs, manages and supports product characterization studies.
- Ensures that all developed methods are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.
- Actively works to foster an environment of effective and collaborative working relationships amongst employees, management, contractors and external partners.
- Ensures that all developed processes are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.
- Supports internal professional development and HR processes including goal setting, individual training, team development/training, and compliance.
Skills and Abilities
- University degree in analytical science, biochemistry or biophysics and a minimum of 8 yearsâ related experience in the pharmaceutical or biotechnology field.
- Experience with protein mass spectrometry, chromatography, capillary electrophoresis, cell-based bioassay and other analytical techniques is desired.
- Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment.
- Consistent analytical reasoning ability.
- Familiarity with regulatory guidelines for method qualification/validation and experience authoring regulatory sections for IND through BLA filings.
- Strong background in the regulatory compliance requirements for the production of biologicals and ADCs for clinical and commercial use.
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.
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