Manager, Quality Control Microbiology

Rentschler Biopharma SE; Milford (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Job summary

Rentschler Biopharma SE in Milford, MA, sucht einen Manager Quality Control Microbiology zur täglichen Leitung des Mikrobiologielabors, Planung von Proben, Sicherstellung der GMP-Einhaltung und Berichterstattung. Sie berichten direkt an den Senior Manager Quality Control Microbiology.

Zu den Aufgaben gehören die Bearbeitung von Abweichungen, CAPAs, Change Controls, Mitarbeiterschulung und Audits sowie die Gewährleistung der Audit-Readiness und Laboreffizienz.

Qualifications

• BS in Mikrobiologie oder verwandten naturwissenschaftlichen Fachrichtungen.
• Mindestens 7 Jahre relevante Berufserfahrung.
• Mindestens 3 Jahre Führungsverantwortung.
• Fundierte Kenntnisse in Umweltmonitoring, Versuchs-/Utilities-Tests und Mikrobiologie-Verfahren.
• Kenntnisse FDA/EMA/USP sowie GMP-Vorschriften.

Responsibilities

• Planung und Priorisierung des täglichen Mikrobiologielaborsbetriebs.
• Überwachung von Arbeitslast, Probenbeständen und Kapazitäten für termingerechte Ergebnisse.
• Verfassen, Begutachten und Abschluss von Abweichungen, CAPAs und Change Controls.
• Unterstützung bei Audits, Inspektionen und Vorbereitung auf Inspektionen.

Education

Bachelor of Science in Mikrobiologie

Tools

Microsoft Office

Job description

locationsMilford, MA, United Statestime typeVollzeitposted onHeute ausgeschriebenjob requisition idJR2819Advancing medicine to save lives. Together.Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.The Manager, Quality Control Microbiology is responsible for the day-to-day management of microbiology laboratory operations, ensuring timely execution of testing activities, staff scheduling, and compliance with GMP requirements. This position focuses on operational execution, maintaining laboratory efficiency, and supporting investigations, change management, and audit readiness activities. The Manager reports directly to the Senior Manager, Quality Control Microbiology.Duties and ResponsibilitiesManage and prioritize daily microbiology laboratory operations to ensure timely execution of routine, stability, environmental monitoring, utility, and non -routine testingDevelop and maintain laboratory testing schedules, resource plans, and personnel assignments to meet operational timelines and business prioritiesMonitor laboratory workload, testing queues, sample inventory, and capacity to ensure efficient utilization of resources and on-time delivery of resultsEnsure completion of all assigned testing activities in accordance with approved procedures, protocols, and GMP requirementsAuthor, investigate, and support closure of deviations, laboratory investigations, CAPAs, and change controls and ensuring timely closure of these quality recordsReview laboratory documentation, test records, and supporting data to ensure accuracy, completeness, and compliance with GMP and data integrity requirementsSupport document revisions, and continuous improvements of laboratory procedures and documentationSupervise, coach, and develop microbiology personnel, including performance management, workload balancing, and day-to-day technical guidanceEnsure personnel training, qualification, and compliance with all applicable training requirementsSupport internal audits, regulatory inspections, and client audits, and ensure the lab maintains a continuous state of inspection readinessMonitor laboratory performance metrics and implement actions to improve efficiency, compliance, and operational effectivenessOversee equipment maintenance, calibration, qualification, and lifecycle activities to ensure continued operational readinessMaintain safety requirements of lab and lab personnelQualificationsBS in Microbiology, biological science, or related scientific discipline7+ years of related experience3+ years in a management/leadership role(s)Experience authoring deviations, CAPAs, and change controlsStrong knowledge of environmental monitoring, utility testing, and microbiological methodsWorking knowledge of FDA, EMA, USP, and GMP regulationsUnderstanding of GMP’s with expectations of a commercial GMP environmentMust communicate effectively (verbal and written) with QC Management and peers. Written communicate skills require full competence in following detailed written instructions, creating/revising SOP’s, and reportsHands on skills and knowledge of quality lab operations including the operation and troubleshooting of lab equipmentAdvanced knowledge of basic chemical and biological safety procedures/precautions Proficient in Microsoft Office – Outlook, Word, Excel, PowerPointWorking ConditionsLaboratory environment/equipment working within MicrobiologyPersonal Protective Equipment must be worn as requiredNormal office working conditions: computer, phone, files, fax, copierPace may be fast and job completion demands may be highPhysical RequirementsFrequent lifting up to 10 lbsFrequent standing/walking to work in lab environment for extended periodsFrequent sitting for extended periods to use computer____________________________________________________________________________Base Pay Range$110,000 - $150,000Disclosure StatementRentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.Brauchen Sie Hilfe?Wenn Sie Unterstützung beim Hochladen Ihrer Bewerbung brauchen, wenden Sie sich bitte an unser Recruiting-Team: [e-mail]