Manager Manufacturing Operations - Site Based Redmond WA
Manager Manufacturing Operations - Site Based Redmond WA
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Job Description
Manager Manufacturing Operations Support Redmond WA
JustEvotec is seeking a highly motivated Solution Prep and Manufacturing Operations Support Manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will be responsible for supervising 610 direct reports and overseeing Day Shift for a 24/7 operation.
The focus of this job is to manage the successful of clinical and commercial manufacturing operations while ensuring cGMP compliance. This position is responsible for managing a shift and requires significant onthefloor presence as well as technical subject matter expertise in operations. Additionally the manager oversees the GMP cleaning group. Job responsibilities include generation and maintenance of cGMP manufacturing and technical documentation troubleshooting and/or providing technical expertise to perform troubleshooting efforts ensuring staff safety training and compliance of plant startup commissioning and validation activities and implement and maintain required cGMP compliant systems. 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.
Shift Work Required Dayshift: WednesdaySaturday 4x10hrs 06:4517:30
Responsibility expectations:
Provide key input in area of Manufacturing Operations expertise that impacts other individuals decisions within the company
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. onboarding via current protocols
Use technical depth and breadth to develop solutions to deviation investigations leads CAPA projects or coordinate more in depth troubleshooting issues where vendors may be involved.
May lead crossfunctional teams within and external to Just. May be a core department lead in NPI. Responds to equipment alarms.
Significant contributions to controlled documents.
Present and/or defend data within and external to our organization (audits).
Communicates logical organized and clearly
Be a technical resource in multiple operational areas within functional group.
Have a deeper understanding of regulatory requirements.
Contribute/ lead implementation of new technology or technical improvements.
Attend conferences/forum
Lead teams within area of expertise within or external to the company.
Hire to fit established culture.
Supervise unit operations within MFG.
Educational Requirements:
- Masters degree and 3 years of Manufacturing & Operations experience
- Bachelors degree and 5 years of Manufacturing & Operations experience
- Associates degree and 10 years of Manufacturing & Operations experience
- High school diploma / GED and 12 years of Manufacturing & 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 leading 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 moderate scope
Ability to organize analyze/interpret and effectively communicate data and results
Motivated selfstarter
Excellent interpersonal team and communication skills
Demonstrating emotional intelligence in decisionmaking motivating teams and fostering a positive workplace culture.
Additional Preferred Qualifications:
Indepth knowledge of equipment operations and engineering principles
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
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 $91560 to $125350; Base salary offered may vary depending on individuals skills experience and competitive market value. Additional total rewards include discretionary annual bonus comprehensive benefits to include Medical Dental and Vision shortterm and longterm 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.
Required Experience:
Manager
Employment Type
Full-Time
