Evote
Manager (Nights)
Evote, Redmond, Washington, United States, 98052
Manager, Manufacturing (Night Shift) – J.POD Downstream Purification
| Just. – Redmond, WAJust is seeking a highly motivated night shift purification manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of downstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position shall be responsible for supervising a shift to cover 24/7 GMP manufacturing operation and requires significant on-the-floor presence, as well as technical subject matter expertise in purification 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, execution of plant start-up commissioning and validation activities, and implementing and maintaining 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.Note:
Nights, Redmond, WA - Night shift- 4 on, 3 off, 3 on, 4 off- Sun to e/o Wed and e/o Wed to Sat - 1900-0800.Educational Requirements:Master’s degree and 3 years of Manufacturing or Operations experience; orBachelor’s degree and 5 years of Manufacturing or Operations experienceQualification Requirements:Able to work night shiftKnowledge of cGMP requirements to ensure complianceSignificant experience in purification operations required for the manufacture of biotherapeuticsCandidate must possess strong focus on quality and attention to detailExecute downstream technology strategies from bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtrationExcellent communication with senior leadershipPossess effective task/time management organizational skillsCapacity to develop solutions to technical issues of moderate scopeAbility to organize, analyze/interpret, and effectively communicate data and resultsMotivated, self-starter with strong mechanical aptitudeGood interpersonal, team, and communication skills are a mustMay lead cross-functional teams within and external to Just. May be a core department lead in NPI.Responds to equipment alarms.Excellent oral and written communication skillsAdditional Preferred Qualifications:Proven record of accomplishment managing, supervising and developing staffIn-depth knowledge of purification equipment, operations, and engineering principlesRecognized technical mastery of disposable manufacturing technologies at commercial scaleParticipation in client and regulatory agency auditsUses technical depth and breadth to develop solutions to deviation investigations, lead CAPA projects, or coordinate more in-depth troubleshooting issues where vendors may be involved.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 supportApplication of knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementActive participation/lead technical projects with collaborators and vendorsExperience 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 $91,560-$125,350; 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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| Just. – Redmond, WAJust is seeking a highly motivated night shift purification manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of downstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position shall be responsible for supervising a shift to cover 24/7 GMP manufacturing operation and requires significant on-the-floor presence, as well as technical subject matter expertise in purification 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, execution of plant start-up commissioning and validation activities, and implementing and maintaining 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.Note:
Nights, Redmond, WA - Night shift- 4 on, 3 off, 3 on, 4 off- Sun to e/o Wed and e/o Wed to Sat - 1900-0800.Educational Requirements:Master’s degree and 3 years of Manufacturing or Operations experience; orBachelor’s degree and 5 years of Manufacturing or Operations experienceQualification Requirements:Able to work night shiftKnowledge of cGMP requirements to ensure complianceSignificant experience in purification operations required for the manufacture of biotherapeuticsCandidate must possess strong focus on quality and attention to detailExecute downstream technology strategies from bioreactor recovery, chromatography column purification, impurity removal, viral inactivation and filtration, UF/DF, and sterile filtrationExcellent communication with senior leadershipPossess effective task/time management organizational skillsCapacity to develop solutions to technical issues of moderate scopeAbility to organize, analyze/interpret, and effectively communicate data and resultsMotivated, self-starter with strong mechanical aptitudeGood interpersonal, team, and communication skills are a mustMay lead cross-functional teams within and external to Just. May be a core department lead in NPI.Responds to equipment alarms.Excellent oral and written communication skillsAdditional Preferred Qualifications:Proven record of accomplishment managing, supervising and developing staffIn-depth knowledge of purification equipment, operations, and engineering principlesRecognized technical mastery of disposable manufacturing technologies at commercial scaleParticipation in client and regulatory agency auditsUses technical depth and breadth to develop solutions to deviation investigations, lead CAPA projects, or coordinate more in-depth troubleshooting issues where vendors may be involved.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 supportApplication of knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementActive participation/lead technical projects with collaborators and vendorsExperience 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 $91,560-$125,350; 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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