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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
The Manufacturing Histology Lead at Cell Marque STL oversees and participates in manufacturing projects and tasks relating to slide manufacturing, block qualification, and block transfers for Control Slides, QC, and Stability; focuses on coordinating, planning, and ensuring production schedules are followed and escalating issues when they arise; implements and utilizes LEAN and Six Sigma methodologies; ensures the labs are aligned with company goals; assists with developing budgets and monitors costs; delivers detailed presentations to management and staff on department activities; performs against departmental and company goals and workflows; ensures safe work practices; carries out administrative duties relating to leading a team of hourly employees. Specific responsibilities include:
Lead and perform processes in the Slide Manufacturing lab and processes related to block qualification as it supports operationsCreate and maintain manufacturing schedules to ensure that scheduled deadlines are metComplete all work in compliance with established cGMP, FDA, OSHA, USDA, EPA, ISO and Quality System regulations, as applicable, to assure output meets established quality and regulatory specifications.Develop, write, and update documents pertaining to lab procedures and product manufacturing to maintain cGMP and ISO compliance; write lab reports or project summaries as requestedRegularly provide status updates to management and present updates to others as neededEscalate any non-conformances and lead the investigation process as neededAs requested, participate in the implementation of cGMP and ISO compliance standards and assist with investigations dealing with manufacturing processes.Aid in developing budgets and cost monitoringCommunicate clearly with the team and facilitate transfer of information from leadership to the teamEducate and enforce Good Manufacturing Practices and compliance with regulationsLead and maintain GMP assessment and improvement efforts for responsible manufacturing labsImplement and utilize LEAN and Six Sigma methodologiesMake recommendations in areas needing improvementAssist in training other staff members as requestedParticipate in developing procedures and forms using paper-based or software-based systems as applicableFacilitate scheduled performance evaluations for the team and work with the Manufacturing Manager to enter reviews into the systemEscalate behavioral and performance issues to management as necessaryLook for ways to improve and promote quality; demonstrate accuracy and thoroughnessExhibit objectivity and openness to others’ views; give and welcome feedback; support others’ efforts to succeedObserve safety procedures; report potentially unsafe conditions; use equipment and materials properlyStrive to continuously build knowledge and skills; share expertise with othersDemonstrate effective group presentation skills; lead, participate in, and present in meetingsRespond promptly to management or employee needs; meets commitmentsApproaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration, presents a professional image in all business mattersConsistently meets productivity standards; strives to increase productivity without sacrificing quality and safety; leads a team to effectively accomplish productivity goalsIdentifies and resolves problems in a timely manner; readily develops alternative solutionsDevelop strategies to achieve organizational goalsDemonstrate persistence and overcome obstacles; measure self against standard of excellenceDisplay original thinking and creativity; meet challenges with resourcefulness; develop innovative ideas Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality ManualOther duties as assigned or required to support the business
Who You Are:
Minimum Qualifications:
Bachelor’s Degree in Biology, Biochemistry, or other Life Science discipline 2+ years of experience in a lab setting within a regulated manufacturing environment
Preferred Qualifications:
Highly detail-oriented with exceptional organizational skills and ability to effectively multi-taskFamiliarity with GMPs, and/or ISO or FDA regulationsStrong written and verbal communication skillsAbility to manage time, prioritize multiple tasks, and work effectively in an open manufacturing environment with minimal supervision and/or directionProficient in Microsoft Office 365: Word, Excel, PowerPoint, SharePoint, and OneDrive applicationsProficiency in SAP Ability to write clearly and informatively and edit own work for correct spelling and grammarAbility to present numerical data effectively; able to professionally routine reports, correspondence, and e-mailsAbility to speak clearly and persuasively in positive and/or negative situationsAbility to listen and gain clarification to address issues professionally and within company policies and guidelinesAbility to read, analyze, and interpret complex instructions, correspondence, policies, procedures, technical documents, financial documentsAbility to make timely decisions and exhibit sound and accurate judgment
RSREMD
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html