Biologist (m/w/d) (Biologe/Biologin)

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(Senior) Manager Quality Management (m/w/d)

Wir bei Leukocare suchen Sie als Verstärkung für unser Qualitätsmanagement in München.

Die LEUKOCARE AG ist ein international agierendes Biotechnologie-Unternehmen mit Firmensitz in Martinsried bei München. Basierend auf unserer Technologie-Plattform entwickeln wir innovative Formulierungen zur Stabilisierung verschiedenartiger Biopharmazeutika, Impfstoffe und Medizinprodukte. Gemeinsam mit unseren internationalen Partnern aus Biotech, Pharma und Medizintechnik setzen wir diese Formulierungstechnologien in verschiedensten biotechnologischen Produkt- und Anwendungsbereichen ein.

Unterstützung der Unternehmensleitung bei der stetigen Weiterentwicklung des internen Qualitätsmanagement-Systems
Vereinbarung von Qualitätszielen mit den operativen Anforderungen einer Entwicklungsorganisation
Unterstützung der Fachabteilungen bei der Konzeption und kontinuierlichen Verbesserung von Prozessen
Unterstützung von Methoden- und Softwarevalidierung
Koordination von und Unterstützung bei der Erstellung, Überprüfung, Revisionierung sowie Freigabe von Vorgabedokumenten
Schulung und Beratung von Mitarbeitenden zu Qualitätsmanagement-Themen
Vorbereitung, Durchführung und Dokumentation von internen Audits
Koordination der Bearbeitung von Qualitätsabweichungsberichten
Betreuung von CAPA-Initiativen
Unterstützung und Beratung im Rahmen von Risikobewertungen
Koordination der Bearbeitung von Kundenreklamationen sowie Unterstützung der Ursachenforschung
Überprüfung der Erreichung von Qualitätszielen und Unterstützung der Erstellung des jährlichen Management Reviews

Abgeschlossenes naturwissenschaftliches oder pharmazeutisches Studium oder vergleichbare Qualifikation
Berufserfahrung im Qualitätsmanagement innerhalb von entwicklungsorientierten Unternehmen bzw. Unternehmensbereichen
Praktische Erfahrung mit den operativen Abläufen eines pharmazeutischen Entwicklungslabors
Ausgeprägtes Qualitätsbewusstsein
Vertrautheit mit ICH-Qualitätsrichtlinien und relevant ISO-Normen (z. B. ISO-9001, ISO-13485)
Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
Sicherer Umgang mit MS-Office-Anwendungen
Zuverlässige und strukturierte Arbeitsweise
Einsatzbereitschaft, Kommunikationsfähigkeit, ausgeprägte Teamfähigkeit, selbstständiges Arbeiten, analytisches Denkvermögen sowie Eigeninitiative
Auf Sie warten spannende und vielseitige Aufgaben in einem hochprofessionellen, kollegialen und interdisziplinären Team. Selbstständigkeit und Eigeninitiative sind ausdrücklich erwünscht und werden von uns gefördert. Wir bieten flache Hierarchien, ein flexibles Arbeitszeitmodell, eine offene Unternehmenskultur sowie eine betriebliche Altersvorsorge. Wir legen Wert auf eine langfristige Zusammenarbeit und bieten Entwicklungsperspektiven im Unternehmen. Daher fördern wir Ihre individuellen Fähigkeiten durch passgenaue Entwicklungsmaßnahmen wie Trainings, Coachings & Workshops.

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

Quality Assurance Manager (f/m/d)

Festanstellung, Vollzeit · Planegg-Martinsried
As a Quality Assurance Manager at CatalYm, you will play a crucial role in ensuring the highest standards of quality and compliance in our clinical development programs. You will be a key driver in maintaining and improving our Quality Management System (QMS) and ensuring inspection readiness. Your responsibilities will include:

Developing and Optimizing Quality Management Systems: support the development, maintenance and continuous improvement of Standard Operating Procedures, Working Instructions, Forms.
Audits: Contribute to the establishment and execution of the yearly audit plans including supervision of CAPA completion and effectiveness checks; Support auditor selection, contracting, and audit execution.
Clinical Trial oversight / Inspection readiness: Collaborate with clinical development teams to ensure robust trial oversight, vendor management, and inspection readiness.
Regulatory Inspections: support preparation and hosting of regulatory authority inspections
Clinical Risk Management: contribute / support clinical Risk Management and the development of risk mitigation strategies.
Training & Knowledge Management: Develop and execute training plans, conduct onboarding training and refresher sessions, develop and maintain training documentation system
Quality-related inquiries: organize and supervise QA mailbox, process inquiries within QA Team and ensure timely replies (either reply as Subject Matter Expert (SME) or contribute to elaboration of reply), participate in selected trial team meetings as SME
QA filing and archiving system: ensure state-of-the-art QA filing and archiving systems, serving as an expert for Trial Master File (TMF) processes.
Education and Experience Requirements:

Degree in natural science (B.Sc and above) or comparable qualification
Demonstrated knowledge of ICH GCP, global regulations and guidelines applicable for the conduct of clinical trials
3-5 years of experience in Quality Management in a GCP-regulated environment within the pharma/biotech industry
Several years of experience in conducting clinical trials according to ICH GCP
Knowledge in the planning, implementation and evaluation of audits in a GCP regulated environment

Skills and Competencies:

Strong analytical, problem-solving, and decision-making abilities
Well-organized with a structured and independent working style
Proactive, hands-on mentality with a team-oriented mindset.
Very good command in English
MS Office skills are required

Impact & Growth - Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
Innovation - Work on groundbreaking immuno-oncology therapies with a mission-driven team.
Collaboration & Culture - Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
Additional Benefits - Competitive compensation, professional development opportunities, and more!

Join us in shaping the future of cancer therapy!

CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us!

Head of Clinical Safety (f/m/d)

Festanstellung, Vollzeit · Planegg-Martinsried

Collaborates cross-functionally internally and with vendors.
Ability to ensure highest quality safety management at aspiring Biotech company.
Leading and mentoring of direct reports and peers on all safety related topics.
Manages the safety vendor and ensures adequate sponsor oversight of all tasks outsourced.
Writing and maintaining Safety SOPs / Templates and forms.
Ensuring inspection readiness and internal Lead in Safety inspections.

Advanced degree within life sciences, Pharmacy or medicine (MD or med. vet.) preferred.
Minimum of 10 years in Clinical Development of which minimum of 5 years in Clinical Safety. (experience in therapeutic area of Oncology / Immuno-Oncology preferred).
Significant experience in strategic safety (signal management, risk assessments, interactions with regulatory authorities) data review, safety reporting, authority interactions (US and EU).
Profound knowledge of all regulatory requirements in the area of GCP and Clinical safety.
Managerial skills to build and manage the Clinical Safety department.
Experience with safety databases (preferred ARGUS).
Proficiency in English, excellent writing skills.
Full-time availability with, ideally, 3-days per week presence in the office.

Impact & Growth - Be part of a dynamic, goal-oriented company where your contributions truly make a difference.
Innovation - Work on groundbreaking immuno-oncology therapies with a mission-driven team.
Collaboration & Culture - Enjoy a multicultural, open, and appreciative work environment and direct communication channels.
Additional Benefits - Competitive compensation, professional development opportunities, and more!

Join us in shaping the future of cancer therapy!

Das Max-Planck-Institut für Biochemie (MPIB) in Martinsried bei München zählt zu den führenden internationalen Forschungseinrichtungen auf den Gebieten der Biochemie, Zell- und Strukturbiologie sowie der biomedizinischen Forschung und ist mit rund 28 wissenschaftlichen Abteilungen und Forschungsgruppen und rund 750 Mitarbeitenden eines der größten Institute der Max-Planck-Gesellschaft zur Förderung der Wissenschaften e. V.

Zur Verstärkung unseres erfolgreichen Career Development Service- und Koordinationsteams suchen wir zum nächstmöglichen Zeitpunkt eine begeisterungsfähige, eigenmotivierte Persönlichkeit (m/w/d) mit hervorragenden Organisations- und Kommunikationsfähigkeiten als wissenschaftlicher

Koordinator (m/w/d) (Elternzeitvertretung)

Der Career Development Service am MPIB bietet koordinierte, umfassende und professionelle Unterstützung für Doktorandinnen, Postdocs (m/w/d) und unsere Forschungsgruppe leiterinnen. Wir bieten interdisziplinäre Ausbildungsmöglichkeiten, eine Reihe von Informationen, Beratung und Unterstützung, um die Forscher*innen am MPIB in jeder Phase ihrer Karriere zu unterstützen.

Pflege des Online-Bewerbungs- und Datenverwaltungssystems sowie der Webseiten des Career Development Service.
Beteiligung an der Koordinierung der Bewerbungsverfahren, einschließlich der Auswahl der Studierenden und der Datenverwaltung.
Organisation von Vorlesungen, Seminaren, Symposien, Retreats und anderen Veranstaltungen für Doktorandinnen und Postdocs (m/w/d). Planung, Organisation und Koordinierung der Ausbildungsprogramme für Doktorandinnen und Postdocs (m/w/d).
Networking, einschließlich der Erstellung von Newslettern, Alumni-Arbeit und Pflege unserer Social-Media-Plattformen.
Zusammenarbeit mit anderen Dienststellen des Instituts und mit anderen akademischen Einrichtungen in der Region zur Unterstützung der oben genannten Aufgaben.

Sie verfügen über einen Doktortitel im Bereich der Biowissenschaften und haben bereits erste internationale Erfahrungen in den Bereichen Bildung, Forschung oder Forschungsverwaltung gesammelt.
Der sichere Umgang mit Computeranwendungen (Microsoft Office, Internet, Datenbanken für soziale Medien, Content-Management-Systeme) ist unerlässlich.
Sie sind lösungsorientiert und ein hervorragender Kommunikator (m/w/d) im Umgang mit Menschen auf allen Ebenen und arbeiten gerne proaktiv und unabhängig in einem wettbewerbsorientierten, internationalen und sehr interaktiven Umfeld.
Darüber hinaus begeistern Sie sich sowohl für die Wissenschaft als auch für die Bildung.
Frühere Erfahrungen mit der Koordinierung von Graduiertenausbildung, Postdoc-Aktivitäten und -Schulungen, Wissenschafts- und Datenbankmanagement, Open-Campus-Plattformen und/oder Kommunikation in sozialen Netzwerken sind von Vorteil.
Gute Kenntnisse der deutschen und englischen Sprache in Wort und Schrift sind erforderlich.

Eine interessante und herausfordernde Tätigkeit in einem führenden internationalen und interdisziplinären Ausbildungsprogramm.
Ein Ihrer Qualifikation und Verantwortung entsprechendes Gehalt (TVöD Bund ab EG 13).
Die Stelle ist zunächst auf ein Jahr befristet.
Umfassende Sozialleistungen mit einer familienfreundlichen Institutskultur und flexiblen Arbeitszeiten.
Zahlreiche Weiterbildungs- und Entwicklungsmöglichkeiten.

Für den

Vertrieb / wissenschaftlichen Außendienst (m/w/d)

suchen wir ab sofort einen engagierten Mitarbeiter mit naturwissenschaftlichem Studium oder mit medizinisch-technischer Berufsausbildung m/w im Vertriebsgebiet Süd (PLZ-Gebiet 7, 8, 9) oder West (PLZ-Gebiet 3, 4, 5, 6)

Viramed® ist ein innovatives Biotechnologie Unternehmen im Bereich der humanmedizinischen Labordiagnostik mit Firmensitz in Planegg bei München.

Hochmoderne analytische Systeme zum Antikörpernachweis auf Chip-basierten Microarrays werden von Viramed® für eine leistungsfähige In-vitro-Diagnostik entwickelt und produziert.

Zu den Kunden zählen niedergelassene Laborärzte, Krankenhäuser, Universitäten und Forschungsinstitute.

Fachlich orientierter Verkauf von innovativen Labortests und Analysesystemen
Erschließung neuer Markt- und Vertriebspotentiale
Flexible Reisetätigkeit im Außendienstgebiet

Naturwissenschaftliches Studium, abgeschlossene Ausbildung als MTA, MTLA, BTA, CTA oder vergleichbare Ausbildung im medizinisch-technischen Bereich
Kommunikations- und Kontaktfreude
Berufserfahrung im Vertrieb wünschenswert
Verkäuferisches Talent, Eigeninitiative und Organisationsvermögen

Ein unbefristetes Arbeitsverhältnis
Abwechslungsreiche Aufgaben in einem hochqualifizierten Team
Eine eigenständige verantwortungsvolle Tätigkeit

metabion is a globally leading supplier of Custom Nucleic Acids renowned for its focus on reliable supplies of consistently high-quality products and services. Our vision is to be the best-in-class producer and service provider of premium custom oligonucleotides - dedicated to enhance scientific progress and to support diagnostic and therapeutic solutions. metabion´s aspiration is to ensure that quality is primary while trust is principle in its relationships with all stakeholders. We are committed to deliver excellence to biotechnological research and applications to promote creativity, innovation and progress for the well-being of our planet - its human and natural resources.

We are currently searching for a Customer & Sales Support Specialist to join our team at our headquarters, Semmelweisstrasse 3, 82152 Planegg, Germany.
Serve as the primary point of contact for metabion customers, providing exceptional support via email, chat, and phone.
Address inquiries related to product availability, specifications, and usage, ensuring prompt and accurate follow-up.
Manage the entire sales process, including validating inquiries, preparing quotations, processing orders, and ensuring their accurate and timely fulfillment. Collaborate with production, finance, and administration teams as needed.
Build and maintain strong client relationships by understanding their short- and long-term needs and aligning them with metabion’s offerings.
Monitor and contribute to the improvement of metabion’s sales-related KPIs, enhancing the efficiency of sales processes.
Provide innovative solutions to customer challenges while driving revenue growth.

A Bachelor’s degree in biology, chemistry, or a related life science field, or equivalent directly-related experience (e.g., two years of relevant industry experience as a technical assistant or similar role equates to one year of college in a related major).
Outstanding communication skills (both written and verbal) in German and English, with a keen eye for detail.

The ideal candidate brings along

A passion for working directly with customers and delivering exceptional service.
A proactive, solution-oriented approach to challenges.
Strong multitasking skills, with the capability to keep accurate records, follow instructions, and adhere to company policies.
Proficiency in using computers and organizational tools, with a scientific mindset.
The ability to work both independently and collaboratively as part of a team.
Positive attitude to drive success.
metabion is committed to providing equal opportunity to all employees and applicants for employment in accordance with all applicable laws, directives, and regulations of Federal, State, and local governing bodies and agencies. We welcome ideas and the changes they bring. We treat each other with dignity and respect.

CatalYm GmbH is a clinical-stage biotechnology company dedicated to advancing cancer treatment through pioneering Visugromab, a recombinant antibody targeting the immunosuppressive cytokine GDF-15. Under physiological conditions, GDF-15 is essential in feto-maternal tolerance and protection of injured tissues. In cancer, GDF-15 is markedly overexpressed across various tumor types, hindering the body's ability to mount effective immune defenses against tumors and contributing to resistance to treatment. Visugromab is designed to neutralize the activity of GDF-15, reinvigorate anti-tumor immune responses, and enhance the activity of cancer immunotherapy. In our commitment to advancing Visugromab, we're looking for a dedicated Associate Scientist to join our research team and contribute to making a difference for cancer patients.
(Associate) Laboratory Manager (m/f/d) - full / part time

The selected candidate will be a member of the Research team and will support the team on the advancement of our understanding of visugromab’s mechanism of action and the identification of novel drug combinations for cancer therapy by supporting the daily operations of a laboratory by overseeing staff, maintaining equipment, and ensuring adherence to safety and quality standards.

Supervise laboratory activities and train laboratory personnel.
Accountable for purchasing, receiving and invoicing.
Coordinate invoicing with Finance.
Assist with budgeting, scheduling, resource and material allocation.
Interact with external vendors and suppliers for quotes.
Support research goals by coordinating lab activities.
Oversee equipment maintenance, life cycle and inventory management.
Ensure compliance with safety, regulatory, and quality standards.
Assist in general laboratory activities (aliquots, buffer preparation, mycoplasma tests) when required.
Responsible for the Gafahrenstoffverordnungliste.

BTA, CTA, MTA, B.Sc. or comparable degree in biology, immunology, biomedicine, biotechnology or related disciplines. Lab management certifications are a plus.
Minimum of 2 years of hands-on experience in a laboratory setting.
Strong familiarity with lab equipment, techniques, and safety protocols.
Proficient in coordinating purchasing, receiving and invoicing.
Experience in coordinating schedules, delegating tasks, and mentoring junior staff.
Familiarity with risk assessment and lab safety best practices.
Strong communication skills for reporting to senior management and training staff.
Organizational skills to manage multiple priorities effectively.
A good command of written and spoken German and English.
Strong aptitude for working in a team.
Excellent problem-solving abilities, attention to detail and adaptability.
Proficient in MS Office working package (Excel, Word, Teams, PowerPoint).
A work permit for Germany is mandatory.

The opportunity to contribute to research directly impacting cancer therapy and clinical trials
Comprehensive training to enhance your scientific, technical, and interpersonal skills
A role in a pioneering environment as part of a dynamic biotech company on the rise
A collegial atmosphere characterized by a driven and supportive team
Opportunity for flexible work schedules and remote work arrangements, within the framework of company policies and dependent on project requirements
A secure and permanent employment contract

metabion is a globally leading supplier of Custom Nucleic Acids renowned for its focus on reliable supplies of consistently high-quality products and services. Our vision is to be the best-in-class producer and service provider of premium custom oligonucleotides - dedicated to enhance scientific progress and to support diagnostic and therapeutic solutions. metabion´s aspiration is to ensure that quality is primary while trust is principle in its relationships with all stakeholders. We are committed to deliver excellence to biotechnological research and applications to promote creativity, innovation and progress for the well-being of our planet - its human and natural resources.

We are currently searching for a Customer & Sales Support Specialist to join our team at our headquarters, Semmelweisstrasse 3, 82152 Planegg, Germany.
Serve as the primary point of contact for metabion customers, providing exceptional support via email, chat, and phone.
Address inquiries related to product availability, specifications, and usage, ensuring prompt and accurate follow-up.
Manage the entire sales process, including validating inquiries, preparing quotations, processing orders, and ensuring their accurate and timely fulfillment. Collaborate with production, finance, and administration teams as needed.
Build and maintain strong client relationships by understanding their short- and long-term needs and aligning them with metabion’s offerings.
Monitor and contribute to the improvement of metabion’s sales-related KPIs, enhancing the efficiency of sales processes.
Provide innovative solutions to customer challenges while driving revenue growth.

A Bachelor’s degree in biology, chemistry, or a related life science field, or equivalent directly-related experience (e.g., two years of relevant industry experience as a technical assistant or similar role equates to one year of college in a related major).
Outstanding communication skills (both written and verbal) in German and English, with a keen eye for detail.

The ideal candidate brings along

A passion for working directly with customers and delivering exceptional service.
A proactive, solution-oriented approach to challenges.
Strong multitasking skills, with the capability to keep accurate records, follow instructions, and adhere to company policies.
Proficiency in using computers and organizational tools, with a scientific mindset.
The ability to work both independently and collaboratively as part of a team.
Positive attitude to drive success.
metabion is committed to providing equal opportunity to all employees and applicants for employment in accordance with all applicable laws, directives, and regulations of Federal, State, and local governing bodies and agencies. We welcome ideas and the changes they bring. We treat each other with dignity and respect.