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Senior Manager, Upstream Manufacturing

Zymeworks
Seattle, WA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Why Work for Us?

Innovation. Act with Integrity. Collaboration. Embrace Diversity. Care

We come from many countries, cultures, races, ethnicities, abilities, and nationalities. We bring our passions including singing, biking, swimming, dancing, cooking, volunteering, parenting, coaching and much more! We are proud of our nearly equal balance of men and women and strengthened by our non-binary and transgender team members. Every employee belongs.

We offer challenging career opportunities, competitive benefits and an environment that recognizes and rewards performance.

Company Description

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of next-generation bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer.  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 seeking a highly motivated professional who is looking to grow their career with our company. This position will report to the Director, Manufacturing Operations and will be based in Seattle, WA.

As a condition of employment, Zymeworks requires all employees to be fully vaccinated against Covid-19 and provide verification of such.

Key Responsibilities

  • Serves as a strategic manager for the company’s external production operations to drive manufacturing and program timelines. 
  • Works directly with the Manufacturing Operations Director, Process and Analytic Sciences, Manufacturing Sciences and Technology and Validation functional teams to plan and implement execution of upstream manufacturing operations.
  • Serves as primary point of contact with contract manufacturing organizations (CMOs) and performs person-in-plant duties as needed to provide technical support for ongoing manufacturing. 
  • Provides technical support for all CMC activities, including investigations, CAPAs, Change Controls, technology transfers, operation and lifecycle management of cGMP manufacturing processes, ensuring all product delivery schedules are met. 
  • Authors and reviews technical CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls and deviations. 
  • Drives timely decisions and facilitates active communication and information flow between CMOs and Zymeworks team members. 
  • Fosters strong, long-lasting cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and external manufacturing entities to ensure successful development of all products. 
  • Monitors and reports Upstream processes performance to ensure DS meets Company objectives.
  • Promotes a culture of continuous improvement in product quality and productivity.
  • Works closely with all internal and external resources to ensure DS supply availability
  • Assists in the selection process for CMOs and other outsourcing partners. 

Qualifications and Experience

  • University degree in science or engineering and a minimum of 7 years related experience in biopharmaceutical GMP operations or an equivalent combination of education and experience. 
  • Experience working with contract manufacturing organizations 
  • Experience in Mammalian cell culture processes
  • 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 
  • Proficiency with cGMP and ICH guidelines. 
  • Proficiency with MS Office.  
  • Embody and champion Zymeworks’ values: Innovate. Act with Integrity. Collaborate. Care.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion. 
  • An equivalent combination of education and experience may be considered.
  • Embody and champion Zymeworks’ values: Act with Integrity. Collaborate. Care.
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion.

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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Zymeworks

Address

Seattle, WA
98161 USA

Industry

Finance and Insurance

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