Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation 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 looking for a Vice President, Commercial Operations to join our Senior Management team. This is an executive position, with leadership responsibility for CMC, Process Development, Formulations as well as for the QA and QC groups.
This position will report to the President & Chief Executive Officer and will be based in Seattle, WA.
- Leads all process development and manufacturing efforts critical for the advancement of Zymeworks’ clinical drug candidates. Establishes, implements and oversees CMC strategy for all manufacturing ranging from pre-clinical, Phase I, Phase II/Phase III through commercial manufacturing ensuring that appropriate scientific, regulatory and quality standards are followed.
Develops, leads and drives the execution of quality assurance strategy for new pharmaceutical development. Ensures effectiveness of quality programs and compliance with applicable regulations and corporate quality expectations.
- Provides technical oversight and project leadership on all Supply Chain and CMC development activities including formulation development, process development and transfer, manufacturing, validation, stability and data review.
- Provides leadership to the CMC, Process Development, QA and QC functions, nurturing a culture of engagement, respect and high-performance within a team environment. Provides leadership, coaching and feedback; mentors and empowers personnel.
- Works with cross-functional program teams providing budgets, updates, and project management support required to achieve pre-clinical and clinical development goals and timelines.
- Drives the CMO/contractor selection process and manages the supply chain operations with CMO’s, suppliers, and internal stakeholders to ensure timely release of drug product required for all clinical studies.
- Prepares CMC documents/sections for product submissions including IND, NDA, NDS, etc. for regulatory bodies.
- Facilitates the preparation process for internal and external audits.
- Directs all aspects of clinical trials material for phase 1 thru 3 studies.
- Establishes and oversees process development strategy and translates into deliverables and milestones to ensure phase-appropriate manufacturing processes; provides informal and formal updates to senior management team.
Ensures timely delivery of quality drug product to support clinical and commercial development in alignment with corporate goals and objectives.
- Establishes and maintains strong relationships with senior executives so as to identify business needs and seek a full range of development solutions.
Qualifications and Experience
PhD in Chemistry, Chemical Engineering or related field and 15+ years’ drug development experience in progressively responsible CMC leadership roles or an equivalent combination of education and experience.
Skills and Abilities
Demonstrated ability to think holistically and long-term across a broad spectrum of industry trends and issues. Ability to envision, shape and communicate long term business objectives and priorities and be able to create competitive and breakthrough strategies and plans
Exceptional leadership skills with the ability to mentor and develop strong contributors. A track record of inspiring and aligning organizations around goals and contributing as an active role model in company values
- Proven history of building relationships and fostering engagement across multiple stakeholders, including the board, senior management, operational levels, suppliers and business partners
- Solid understanding of all facets and phases of CMC drug development
- Strong expertise in GMP regulations for the manufacturing of finished product for human clinical studies
- Knowledge of CMC requirements for regulatory filings covering all phases of pre-clinical and clinical development
- Demonstrated ability to negotiate and manage CRO and CMO contracts and activities
- Proven track record of moving compounds from pre-clinical toxicology studies through IND filing and human clinical studies
Strong track record of meeting and exceeding goals. Demonstrated ability to drive steep change as well as incremental, continuous improvements in quality, efficiency and growth through change initiatives and vigorous leadership
Ability to effectively use appropriate interpersonal styles and communication methods to influence, motivate and develop mutually beneficial relationships and outcomes
Excellent analytical and conceptual thinking abilities; forward-looking. Out of the box problem solving skills
Sound business acumen with a practical, results-oriented management style that can translate innovative, creative strategies and conceptual thinking into action plans
Demonstrated high level of integrity and ethics
Why Work for 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.