Senior Manager, Drug Product

Manufacturing Seattle, Washington


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

The Manager, Drug Product will report to the Director, Manufacturing Operations and will be based in Seattle, WA.

Key Responsibilities:

  • Supports drug product manufacturing, and acts as primary point of contact between Zymeworks and CMOs.
  • Drives liquid and Lyophilized drug product manufacturing processes suitable for both clinical and commercial use.
  • Troubleshoots complex drug product manufacturing challenges requiring in-depth knowledge of lyophilization and liquid fill equipment. 
  • Supports technology transfer, review of master batch records, change control process, technical manufacturing deviation investigations, and review of executed batch records.
  • Provides onsite support during production at CMOs to ensures overall compliance, appropriate resolution to critical issues, and timely progress updates.
  • Assists operational objectives by providing information and recommendations to strategic plans and budget reviews, and supporting department budget activities
  • Act as Person in Plant (PIP) to oversee process development and manufacturing activities at CMOs.
  • Author drug product related regulatory reports and submissions.
  • Regularly interacts with and gains acceptance of stakeholders, including CMC, Clinical Operations, Regulatory Affairs, Quality, senior departmental staff, and Process Development functions, to ensure effective cross-functional communication.
  • May manage employees. Monitors performance encourages growth and facilitates the development of team members’ skills through training, mentorship opportunities and sharing of knowledge.
  • Leads through example to establish an environment fostering effective and collaborative working relationships.

 Education and Experience:

  • University degree and a minimum of 5 years’ related experience in clinical or commercial Drug Product manufacturing management or equivalent combination of education and experience.

Skills and Abilities:

  • Industry experience in a manufacturing setting or working with CMOs is preferred.
  • Participation in PAIs and experience supporting regulatory inspections a plus.
  • Lyophilization experience preferred.
  • 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.
  • In-depth knowledge of the clinical drug development process (Phase I-III).
  • In-depth knowledge of cGMPs and familiar with US and EU regulations and quality standards applicable to antibody-based therapeutics and antibody-drug conjugates.
  • Strong attention to detail and problem-solving skills, with excellent project management skills.
  • Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
  • Excellent customer-service orientation, high degree of professionalism, and the ability to work with limited direction.
  • Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks.
  • Ability to multi-task and shift priorities quickly while working under tight deadlines.

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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