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Associate Director, Process Development

Employer
Zymeworks Inc
Location
Seattle, Washington
Salary
Competitive salary and benefits
Closing date
Jun 30, 2019

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Job Details

Associate Director, Process Development

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, Process Development to join our Therapeutics Development group. The successful candidate will be accountable for late phase and commercial process development. This position in Zymeworks CMC group is responsible for leading the process development and 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, Process Development will be based in Seattle, WA and will report to the Director, Therapeutics Preclinical Development.

Key Responsibilities:

  • Contributes their expertise to the strategic planning, direction and support of upstream and/or downstream process development for all phases of clinical development including support of late clinical phase and commercial filings.
  • Collaborates within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for novel biotherapeutics and ADCs.
  • 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 antibody, bispecific and 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 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.

How to Apply

If you are interested in this challenging opportunity, please apply online at https://zymeworks.bamboohr.co.uk/jobs/view.php?id=157 .  Due to the high volume of applicants, only those selected for interviews will be contacted.

Company

Zymeworks Inc

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