Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation bispecific and multifunctional biotherapeutics. 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.
About the Position
Zymeworks is currently seeking a Associate Director, Antibody Drug Conjugate (ADC) Process Development in the Process Developemnt and Analytics group. The successful candidate will be accountable for all phases of conjugation process development as well as supporting the GMP manufacture of novel drug-linkers. This position is responsible for leading the process development and supporting the subsequent manufacturing of novel biotherapeutics and ADCs in collaboration with contract manufacturing organizations. This will include frequent 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.
The Associate Director, Antibody Drug Conjugate (ADC) Process Development will be based in Seattle, WA and will report to the head of the Process Development and Analytcis department.
• Contributes their expertise to the strategic planning, direction and support of conjugation process development for all phases of clinical 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 ADCs.
• Supports the GMP manufacture of ADCs as well as the drug-linker intermediate.
• Leads project-specific efforts in process development, scale-up, production and tech transfer of processes within and between CMOs.
• Participates in the development of RFP’s to solicit project specific bids from CMOs/CROs.
• Develops SOWs defining work to be performed and provide subsequent oversight of experiments and activities conducted at the CMO/CRO.
• Develops highly productive manufacturing processes in a timely manner for novel ADC therapeutics. Brings issues to the attention of appropriate personnel as necessary.
• 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 process characterization studies and develop control strategies for process validation.
• Contributes to budget projections, raw/clinical material and staffing forecasts.
• Actively works to foster an environment of effective andcollaborative 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 and a minimum of 8 years’ related experience or equivalent combination of education and experience.
• Ability to lead through example and to establish an environment fostering effective and collaborative working relationships.
• 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 QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.
• Strong background in the regulatory compliance requirements for the production of biologicals and ADCs 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.
• Strong oral, written and listening skills.
• Proficiency with MS Office.
Why Work With Us?
Zymeworks’ employees are passionate, engaged and extremely motivated to succeed. We are excited by the cutting-edge science and technology, the endless possibilities this union holds and the sheer opportunity to be a part of something big. To learn more about Zymeworks Inc. and our current openings, please visit our website at www.zymeworks.com.
We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.
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.