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Manager, Manufacturing

1 month ago

Seattle WA United States Evote Full time

The focus of this job is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for supervising a shift to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations. Additional job responsibilities include:

  1. Generation and maintenance of cGMP manufacturing and technical documentation
  2. Troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations
  3. Ensuring staff training and compliance
  4. Execution of plant start-up commissioning and validation activities
  5. Implementing and maintaining required cGMP compliant systems
  6. Participating in finite scheduling, aspects of technology and/or process transfer
  7. Identifying process gaps and technology issues, determining solutions and remediation plans
  8. Providing support for regulatory and site inspections
  9. Providing input to department capital and expense budgets

Note: Manufacturing operations in Jplant Seattle occur 7 days a week, day shifts only and extended shifts as required based on process requirements. 40 hours, days only. Shifts could be: Monday to Friday, Tuesday to Saturday or Sunday to Thursday, between 8:00 am till 5:00 pm.

Educational Requirements:

  • Master’s degree and 4 years of Manufacturing or Operations experience; or
  • Bachelor’s degree and 6 years of Manufacturing or Operations experience

Qualification Requirements:

  • Proven record of accomplishment managing, supervising and developing staff
  • Knowledge of cGMP requirements to ensure compliance
  • Significant experience in cell culture operations required for the manufacture of biotherapeutics
  • Strong focus on quality and attention to detail
  • Excellent communication with senior leadership
  • Effective task/time management organizational skills
  • Capacity to develop solutions to technical issues of moderate scope
  • Ability to organize, analyze/interpret, and effectively communicate data and results
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills
  • May lead cross-functional teams within and external to Just
  • Responds to equipment alarms
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • In-depth knowledge of cell culture equipment, operations, and engineering principles
  • Recognized technical mastery of disposable manufacturing technologies at commercial scale
  • Participation in client and regulatory agency audits
  • Using technical depth and breadth to develop solutions to deviation investigations, lead CAPA projects, or coordinate troubleshooting issues with vendors
  • Fundamental understanding and basic operation of process automation (DeltaV)
  • Experience in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns
  • Application of knowledge and expertise to solve complex technical problems
  • Active participation/lead technical projects with collaborators and vendors
  • Experience with finite scheduling tools and allocation of resources and equipment

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $91,560 to $126,500; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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