Manager, Manufacturing

3 weeks ago

Redmond, United States Just - Evotec Biologics Full time

Manager, Manufacturing Operations - Support | Redmond, WAJust-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 experienceBachelor's degree and 5 years of Manufacturing & Operations experienceAssociate's degree and 10 years of Manufacturing & Operations experienceHigh school diploma / GED and 12 years of Manufacturing & Operations experienceQualification Requirements:Proven knowledge of cGMP requirements to ensure complianceSignificant experience in solution prep and facility cleaning operations as required for the manufacture of biotherapeuticsProven record of accomplishment managing, supervising, and developing staffCandidate must possess strong focus on quality and attention to detailPossess 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 mustExcellent oral and written communication skillsAdditional Preferred Qualifications:In-depth knowledge of solution prep and facility cleaning.Recognized technical mastery of disposable manufacturing technologies at commercial scaleParticipation in client and regulatory agency auditsExperience with finite scheduling tools and allocation of resources and equipmentChange control, NC/CAPA, and deviationsFundamental 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 plusApplies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancementSignificant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the teamActive participation/lead technical projects with collaborators and vendorsThe 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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