Evotec WD
Senior Vice President, Global Manufacturing Operations
Evotec WD, Redmond, Washington, United States, 98052
Senior Vice President, Global Manufacturing Operations
Location:
Redmond, Field Based US - West Coast, SeattleTime Type:
Full timePosted On:
Posted 3 Days AgoJob Requisition ID:
JOB ID-11200This key role is responsible for shaping and overseeing the strategic direction of continuous manufacturing platforms, MSAT, Materials Management, and other relevant support functions within our global manufacturing network.Responsibilities:Leadership and Strategy
Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectivesDevelop/Build a scalable manufacturing organization to meet the corporate goalsProvide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challengesFoster a culture of quality and compliance throughout the organizationKey Responsibilities:
Manage site performance, ensuring operational excellenceReview and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirementsPlan staff and equipment operations schedulingSuccessfully execute advanced biologics manufacturing technologiesTroubleshoot and/or provide technical expertise to perform or lead investigationsAssist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systemsProvide support for regulatory and site inspectionsManage OPEX and CAPEX budgets; develop a culture of continuous improvementIncorporate and expand sustainability into manufacturing operationsBuild and develop staff for future roles and career progressionEnsure a culture of safetyEducational Requirements:
PhD or Master’s degree in biological or engineering science with 15+ years relevant experience orBachelor’s degree in biological or engineering science with 20+ years relevant experienceQualifications:
Extensive experience in late-stage/commercial biologics drug substance manufacturingTechnical mastery of cell culture and purification operations at commercial scaleProven knowledge of cGMP requirements to ensure complianceAdvanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operationsValidation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reportsStrong understanding of process automation (e.g. DeltaV) and BAS systemsExperienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP systemsPrevious experience managing the activities of individuals, work groups, and project teamsPossess strong focus on quality and attention to detailPossess effective task/time management organizational skillsMotivated, self-starter with strong mechanical aptitudeGood interpersonal, team, and communication skills are a mustExcellent oral and written communication skillsStrong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)Additional Preferred Qualifications:
Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelinesIn-depth knowledge of equipment, operations, and engineering principlesExperienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plusExperienced in Development, scale-up, and transfer of biologics production processesKnowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementActive participation/lead technical projects with collaborators and vendorsThe base pay range for this position at commencement of employment is expected to be $200,000 to $350,000. 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.About Us
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 to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.Please click on the link below to access and review our Privacy Information for Applicants:
#J-18808-Ljbffr
Location:
Redmond, Field Based US - West Coast, SeattleTime Type:
Full timePosted On:
Posted 3 Days AgoJob Requisition ID:
JOB ID-11200This key role is responsible for shaping and overseeing the strategic direction of continuous manufacturing platforms, MSAT, Materials Management, and other relevant support functions within our global manufacturing network.Responsibilities:Leadership and Strategy
Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectivesDevelop/Build a scalable manufacturing organization to meet the corporate goalsProvide strategic leadership to the global manufacturing organization, ensuring the team is equipped to meet current and future challengesFoster a culture of quality and compliance throughout the organizationKey Responsibilities:
Manage site performance, ensuring operational excellenceReview and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirementsPlan staff and equipment operations schedulingSuccessfully execute advanced biologics manufacturing technologiesTroubleshoot and/or provide technical expertise to perform or lead investigationsAssist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systemsProvide support for regulatory and site inspectionsManage OPEX and CAPEX budgets; develop a culture of continuous improvementIncorporate and expand sustainability into manufacturing operationsBuild and develop staff for future roles and career progressionEnsure a culture of safetyEducational Requirements:
PhD or Master’s degree in biological or engineering science with 15+ years relevant experience orBachelor’s degree in biological or engineering science with 20+ years relevant experienceQualifications:
Extensive experience in late-stage/commercial biologics drug substance manufacturingTechnical mastery of cell culture and purification operations at commercial scaleProven knowledge of cGMP requirements to ensure complianceAdvanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operationsValidation experience, including risk assessments (SIA and CIA), user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reportsStrong understanding of process automation (e.g. DeltaV) and BAS systemsExperienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP systemsPrevious experience managing the activities of individuals, work groups, and project teamsPossess strong focus on quality and attention to detailPossess effective task/time management organizational skillsMotivated, self-starter with strong mechanical aptitudeGood interpersonal, team, and communication skills are a mustExcellent oral and written communication skillsStrong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)Additional Preferred Qualifications:
Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelinesIn-depth knowledge of equipment, operations, and engineering principlesExperienced in technology and/or process transfer for late-stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plusExperienced in Development, scale-up, and transfer of biologics production processesKnowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementActive participation/lead technical projects with collaborators and vendorsThe base pay range for this position at commencement of employment is expected to be $200,000 to $350,000. 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.About Us
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 to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn.Please click on the link below to access and review our Privacy Information for Applicants:
#J-18808-Ljbffr