Biotechnologe (m/w/d) (Ingenieur/in - Biotechnologie)

Join our R&D team in Munich

Leukocare AG, based in Martinsried, Germany is a biotechnology company specializing in the development of biopharmaceutical formulations. Operating at the interface of drug and product development, Leukocare combines in-depth knowledge of formulation development with bioinformatics and artificial intelligence. Leukocare's innovative best-in-class drug product formulations can be used for a wide range of modalities: Biologics & Biosimilars, Vaccines & Viral Vectors, and Biofunctionalized Devices. Currently, Leukocare employs 50 people.

Managing multiple client projects simultaneously in terms of timeline, quality, and cost and acting as a commercial representative to clients
Identifying risks, elaborating mitigation strategies, and executing measures
Proactively upselling in running projects
Enhancing client satisfaction and client relationship management

University degree preferably in sciences (biotechnology, pharmacy, biology, or similar)
At least 5 years’ experience in scientific research, project management, or similar in biotech or pharma
At least 2 years of experience leading complex cross-functional projects
Experience in CMC (drug product development, GMP DS or DP manufacturing, formulation, analytics)
Fluent in English; knowledge of German is a plus
Strong communication and presentation skills
Customer centricity
Good negotiation skills
Strong problem-solving skills
Self-organized with excellent time management skills
Teamwork, flexibility, high workload capacity, independent work
Exciting and versatile tasks await you in a highly professional, collegial, and interdisciplinary team. We offer flat hierarchies, a flexible working time model, an open company culture, and a company pension scheme. Personal initiative is expressly desired and encouraged. You will actively support the growth of Leukocare's business. We value long-term cooperation and offer development prospects within the company. We therefore promote your individual skills through tailored development measures such as training and coaching.

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.


Das Arbeitssicherheitsmanagementsystem der MPG stellt eine SAP-basierte, zentralisierte Plattform aus Werkzeugen zur Erfassung, Dokumentation, Organisation und Speicherung arbeitssicherheitsrelevanter Daten und Prozesse dar. Das System wird fortlaufend von fachlicher und technischer Seite aus umfassend betreut und weiterentwickelt.


Wir suchen schnellstmöglich einen


Mitarbeiter (m/w/d) für das Arbeitssicherheitsmanagementsystem der MPG

Das Angebot richtet sich insbesondere an Naturwissenschaftler (m/w/d) und Ingenieure (m/w/d), die sich beruflich in die Bereiche Arbeitssicherheit, Organisation und Management entwickeln möchten. Teilzeit ist prinzipiell möglich.

Unterstützung bei der fachlichen Aktualisierung, Weiterentwicklung und Prozessoptimierung des zentralen Arbeitssicherheitsmanagementsystems der MPG (SAP-basiert)
Unterstützung bei der Umstellung des Managementsystems auf eine neue SAP-Plattform (S/4HANA)
Fachlicher Support der Anwender*innen und Fachkräfte für Arbeitssicherheit der Institute bei der Nutzung dieser Software
Interaktion mit verschiedenen Fachbereichen und Disziplinen der Institute und der Generalverwaltung der MPG
Unterstützung bei der Durchführung von Anwenderkreistreffen, Workshops und Schulungen

Hochschul- oder Universitätsabschluss (B.Sc. / B.Eng., M.Sc. / M.Eng.) bzw. vergleichbare naturwissenschaftliche oder technische Berufsausbildung
Ausgeprägtes Interesse an Naturwissenschaften, Gesundheitsschutz und Arbeitssicherheit
Freude am Arbeiten im Team und ausgeprägte Hands-on-Mentalität
Bereitschaft und Freude, sich aktiv in neue Themen einzuarbeiten
Hohe Lernbereitschaft, gepaart mit hohem Engagement und hoher Motivation
Erfahrungen im Forschungsbereich und in der Arbeitssicherheit sind von Vorteil
Sicherer Umgang mit EDV-Applikationen und hohe IT-Affinität
Gute Englischkenntnisse in Wort und Schrift

Interessante, verantwortungsvolle und abwechslungsreiche Tätigkeit in einer renommierten Forschungseinrichtung mit internationalem Umfeld
Intensive und ausführliche Einarbeitung, flache Hierarchien
Anspruchsvolles Projekt und großer Gestaltungsspielraum sowie viel Freiraum für Eigeninitiative
Sehr gutes Betriebsklima, familiäres Arbeitsumfeld und wertschätzender Umgang
Modern eingerichteter Arbeitsplatz
Flexible Arbeitszeiten und die Möglichkeit des mobilen Arbeitens
Vielfältige Fortbildungs- und Entwicklungsmöglichkeiten (z. B. EDV, Projektmanagement, Sprachkurse etc.)
Vereinbarkeit von Beruf und Familie (Kinderbetreuungseinrichtung vor Ort, Kooperation mit einem Familienservice)
Soziale Leistungen des öffentlichen Dienstes (betriebliche Altersversorgung, Jahressonderzahlung, vergünstigte Jobtickets)
Aktives betriebliches Gesundheitsmanagement und Sportangebote (u. a. Boulderwand, Tennisplätze, Firmenfitness, Möglichkeit zur Nutzung des EGYM Wellpass)

The Max Planck Institute of Biochemistry (MPIB) in Martinsried is one of the world's leading research institutions in the fields of biochemistry, cell and structural biology and biomedical research. With approximately 30 scientific departments and research groups and about 750 employees, the MPIB is one of the largest institutes of the Max Planck Society.

Research scientist (m/f/d), postdoc (m/f/d) or engineer (m/f/d) in electron microscopy

in the Department of Cell and Virus Structure/CryoEM Technology

to work with Dr. John Briggs and Dr. Juergen Plitzko

We are looking for a scientist or engineer with a strong technical background in transmission electron microscopy, who is interested in performing research in methods and technology for cryo-electron microscopy and tomography.

The Max Planck Institute of Biochemistry has a vibrant community of electron microscopists that develops and uses novel cryo-electron microscopy, tomography, and FIB-SEM methods and that works closely with industrial partners. The institute has a rich history of successful hardware and software development in this area and currently operates a large fleet of TFS electron microscopes including four Titan Krios, an Arctica, two Glacios, an Arctis plasma-FIB and two Aquilos FIB-SEMs. A subset of these microscopes are assigned to technology development and state-of-the-art applications and are managed by the research groups of John Briggs and Juergen Plitzko. These groups include staff with backgrounds including physics, materials sciences, electrical engineering, biochemistry and bioinformatics, providing many opportunities for interdisciplinary collaborations as well as international cooperation.

In this position you will

·       Perform scientific research aimed at developing, implementing and optimizing new and improved methods and workflows for cryo-electron tomography, microscopy and focussed-ion beam milling.

·       Collaborate with other scientists and companies developing and testing new hardware and software for electron microscopy and associated equipment.

·       Collaborate with and support other scientists to learn and apply new and improved cryo-electron tomography and related techniques to biological questions.

·       Help to ensure the smooth operation of the electron microscopes used for research and development.

The ideal candidate will have a scientific, engineering or technical background and will have several years of experience in high-resolution transmission electron microscopy, preferably cryo electron microscopy, including tomography. They will have a strong, demonstrated interest in the technical and methodological aspects of electron microscopy. We are looking for a colleague who enjoys independent research and at the same time is a community-minded and collaborative individual who wants to support other scientists to apply new or state-of-the-art methods. The working language is English. Excellent inter-personal skills are required.

The salary level will be according to TVöD (Bund) (public salary scale). The initial appointment is for two years with the possibility for extension.

The Max Planck Society strives for gender equality and diversity. Furthermore, the Max Planck Society has set itself the goal of employing more severely disabled people. Applications from severely disabled people are expressly encouraged.

For further information about the MPIB, please visit www.biochem.mpg.de (http://www.biochem.mpg.de) . Informal enquiries can be directed to
Dr. John Briggs ([email protected] (https://mailto:[email protected]) ).

Please note: We kindly ask that you apply exclusively via our online application management. Applications by e-mail will not be considered for data protection reasons.

Have we aroused your interest? Please submit your application documents (pdf-files) via our
online application website (https://recruitingapp-5446.de.umantis.com/Vacancies/490/Application/CheckLogin/31?lang=gerger) by May 17, 2024.

Senior Regulatory Affairs Manager (gn) CMC - Drug Product
Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of more than 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.

To support our team in Martinsried near Munich, we are looking for suitable candidates for this full-time and permanent position, to begin work as soon as possible.
    Planning, writing and compilation of regulatory documents for with focus on CMC documentation for sterile drug product development, site transfers and lifecycle activities
    Coordination of regulatory activities with involved stakeholders (e.g. internal functional departments, external CMOs/CROs, license partners)
    Development and implementation of CMC regulatory strategies during product development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are considered and implemented in the development programs
    Participation in technical project teams and point of contact for external partners and CMOs/CROs for regulatory topics
    Review and approval of documents/plans/reports from CMOs/CROs and internal functional departments
    Regulatory compliance check of documents and evaluation of change controls
    Support design control for combination products and related regulatory documents
    Providing professional guidance and coordinating project support from colleagues
    Leading discussions internally and with external partners and participation in health authority meetings

    Scientific background with master’s degree or PhD preferably in biotechnology, biochemistry, biology or equivalent
    Minimum five years of experience in CMC RA area preferably with focus on aseptically manufactured drug products
    Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA required
    First experience with design control process for combination products or medical devices would be of advantage
    Experience with biosimilars and knowledge of corresponding EMA/FDA guideline requirements would also be of advantage
    Very strong matrix leadership and communication skills
    Excellent team-player, able to coordinate, prioritize and manage a variety of tasks and issues, proactive and result-oriented, able to work independently
    Fluency in written and spoken English (German language a plus)
    Proficiency in MS-Office

    Flexible working time
    Hybrid work
    30 days paid vacation
    Formycon pension
    Group accident insurance
    Formycon card
    Continuing education offers
    Team spirit, great working atmosphere and much more!

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.