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Manager, Manufacturing - Redmond, United States - Evotec WD
Description
Manager, Manufacturing – J.POD Solution Prep and Mfg Ops Support page is loadedManager, Manufacturing – J.POD Solution Prep and Mfg Ops Support
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locations
Redmond
time type
Full time
posted on
Posted 3 Days Ago
job requisition id
JOB ID-09814
Manager, Manufacturing Operations - Support | Redmond, WA
Just-Evotec is seeking a highly motivated Solution Prep and Mfg Ops Support Manager that desires a significant opportunity to improve worldwide access to biotherapeutics.
The focus of this job is to guide the successful execution of clinical and commercial manufacturing operations while ensuring cGMP compliance.
This position will be responsible for supervising and overseeing Day/Swing/Night shifts and to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in Solution Prep, Facility Cleaning and other GMP support operations.
Additional job responsibilities will 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 and implement and maintain required cGMP compliant systems.
The manager 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.
Basic Qualifications:
Master's degree and 3 years of Manufacturing & Operations experience
Bachelor's degree and 5 years of Manufacturing & Operations experience
Associate's 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 solution prep and facility cleaning operations as 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
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, self-starter with strong mechanical aptitude
Good interpersonal, team, and communication skills are a must
Excellent oral and written communication skills
Additional Preferred Qualifications:
In-depth knowledge of solution prep and facility cleaning.
Recognized technical mastery of disposable manufacturing technologies at commercial scale
Participation in client and regulatory agency audits
Experience with finite scheduling tools and allocation of resources and equipment
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 is a plus
Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
Active participation/lead technical projects with collaborators and vendors
The base pay range for this position at commencement of employment is expected to be $100,000 to $130,000; 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.
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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Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients.
The Company's multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products.
Evotec leverages this "Data-driven R&D Autobahn to Cures" for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders.
Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases.Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development.
Evotec operates globally with more than 5,000 highly qualified people. The Company's 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go toand follow us on X/Twitter @Evotec
and LinkedIn .
Please click on the link below to access and review our Privacy Information for Applicants:
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