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Senior Manager, Manufacturing Operations

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Job Id JOB ID-10896 Standort Seattle, Washington Veröffentlichungsdatum 05/13/2024 Job Kategorie Biomanufacturing

Senior Manager, Manufacturing Operations – J.POD Cell Culture

The focus of this role is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for supervising and overseeing multiple shifts to cover 24/7 operations and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations.Additional job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implementation and maintenance of required cGMP compliant systemsThis individual may also participate in finite scheduling, aspects of technology and/or process transfer, identify process gaps and technology issues, determine solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets. 

Responsibility levels:

  • Provide expertise and makedecisions that impact project teams brings in new technologies&  literature "

  • Use technical expertise to design/ implement new equipment, new disposable assemblies, or new molecule projects without guidance of prior protocols.  

  • Provide technical guidance to others within the company - develop new protocols

  • High complexity, high (multi molecule)impact, challenging systems, coordinate interconnected systems/equipment, ID trends or non obvious issues/error traps/prevention

  • Coordinate with leadership to initiate and lead new teams toaddress technical challenges "

  • Communicate and/or present technical information to a diverse set of audiences, including senior management, regulatory agencies, and clients  - bridge to Sr manager - more targeted communication

  • Be a technical resource in multiple operational areas within functional group.  

  • Possess a deeper understanding of regulatory requirements.  

  • Contribute/ lead implementation of new technology or technical improvements.  

  • Represent Just externally

  • Lead a Process or cross-company team. Lead investigations of operational/ quality issues. Lead and develop direct reports in the upstream functional areas with direct reports. SME for specialized areas (ex.training)

  • Establish culture and hire to fit."

  • Develop an emotionally intelligent organizational culture that values diversity, encourages open communication, and supports employee well-being.

  • Supervise managerial tasks and team objectives.

  • Apply emotional intelligence in negotiations, understanding the emotional needs of stakeholders, and finding mutually beneficial solutions.

  • Consider the emotional impact of business decisions on various stakeholders, including employees, customers, and the community.

Educational Requirements:

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

  • Bachelor’s degree and 8 years of Manufacturing or Operations experience  

Qualification requirements:

  • Proven knowledge of cGMP requirements to ensure compliance

  • Significant experience in operations required for the manufacture of biotherapeutics

  • Proven record of accomplishment managing, supervising and developing staff 

  • Candidate must possess strong focus on quality and attention to detail

  • Excellent communication with senior leadership 

  • Possess effective task/time management organizational skills

  • Capacity to develop solutions to technical issues of challenging 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 are a must

  • Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team

  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • In-depth knowledge of biotech equipment, operations, and engineering principles 

  • Recognized technical mastery of disposable manufacturing technologies at commercial scale

  • Participation in client and regulatory agency audits 

  • Change control, NC/CAPA, and deviations

  • Fundamental understanding and basic operation of process automation (DeltaV

  • Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support 

  • Application of knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement

  • Active participation/lead technical projects with collaborators and vendors 

  • Experience with finite scheduling tools and allocation of resources and equipment

The base pay range for this position at commencement of employment is expected to be $92800 to $152425;  Base salary offered may vary depending on 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.

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.

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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