Biologist, Chemist - Teamlead, Regulatory Affairs (m/f/d)

The Max Planck Institute for Biological Intelligence (MPI-BI) focuses on basic research on topics in behavioural ecology, evolutionary research and neuroscience. Here, around 500 employees from around the world study how animal organisms acquire, store, apply and pass on knowledge about their environment in order to find ever-new solutions to problems and adapt to a constantly changing environment. World class scientific research work is at the core of the IMPRS-BI mission. We provide an English-speaking, structured PhD programme with ready access to state-of-the-art facilities. To foster high quality of scientific research, IMPRS-BI students are offered expert supervision; the thesis is conducted under the guidance of the direct advisor and a thesis advisory committee.
An additional training curriculum in scientific, computational, and transferable skills, tailored to each student’s individual needs, endows our graduates with a competitive edge in the job arena, both in academia and beyond. We encourage highly qualified candidates with a strong commitment to basic research to apply.
Applicants should hold a MSc with a background in biology, chemistry, physics, psychology, cognitive neuroscience, computer science, mathematics or related fields. Outstanding candidates with a BSc shall be considered for the fast-track program of GSN-LMU, our partner PhD program.
For more information, eligibility criteria and online application please visit our website: https://imprs-bi.mpg.de/ The new IMPRS-BI offers first-rate training to doctoral students interested in the question of how nervous systems develop and have evolved to allow animals to pursue their goals, navigate their environment and employ behavioral strategies that are adapted to, and shape, their respective ecological niche.

An English-speaking, structured PhD program
Access to state-of-the-art facilities
Individual supervision and mentoring
Full funding, with no tuition costs
Training in scientific, computational and transferable skills

The Graduate School Life Science Munich (LSM-LMU) offers an international doctoral programme in life sciences covering areas of Anthropology, Biochemistry and Cell Biology, Ecology, Evolution, Genetics, Microbiology, Plant Sciences, Systematics and Zoology to motivated and best qualified next generation researchers at one of Europe’s top Universities. The research training on a specific project will be supplemented by seminars, retreats, methods courses, training in transferable skills and participation in at least one international conference.
LMU is situated in Munich, one of the most beautiful cities in Germany. With its unique blend of cosmopolitan flair and traditional warmth, Munich is home to 1.3 million residents and stands as the political, cultural, and economic capital of Bavaria. Ranked as the fourth-best university city in the world, Munich has evolved over the past four decades into one of Europe’s leading hubs for science and industry. The Munich area hosts the German or European headquarters of numerous high-tech companies. Despite its modern advancements, Munich is still affectionately known as the "city with a kind heart." LSM calls for doctoral applications on a yearly basis, open from the 1st of September until the 24th of October 2024.

Please find below the doctoral projects´ descriptions:


Geigenberger group (Plant Metabolism):
Project 1: https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/cold-acclimation-geigenberger.pdf
project 2: https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/light-acclimation-geigenberger.pdf


Grath group (Evolutionary Biology): https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/sonja-grath-lsm-2024.pdf


Jung group (Microbiology):
https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/kjung-2023.pdf


Leister group (Plant Sciences):
https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/leister-trr-23.pdf


Osman group (Cell Biology):
https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/osman_cell-bio-2024.pdf


Robatzek group (Plant Biology):
https://www.lsm.bio.lmu.de/apply/pdh_projects/lsm-doctoral-projects/robatzek-23.pdf


DAAD-GSSP associated projects- Only international (non-German) applicants, who have not been in Germany longer than 15 months by the nomination time at the DAAD (around Feb/March 2025) are eligible for the DAAD-GSSP scholarships! https://www.lsm.bio.lmu.de/apply/pdh_projects/pdh_projects_daad-lsm/index.html


CSC-LMU associated projects- Only Chinese candidates are eligible for the CSC scholarships. https://www.lsm.bio.lmu.de/apply/pdh_projects/pdh_projects_csc-lsm/index.html


You hold or currently pursuing a Master's degree (MSc) in biology, biochemistry, bioinformatics, biophysics, biotechnology, medicine or in another related discipline.



Fluency in both written and spoken English.
As a doctoral candidate of the Graduate School LSM, you will be part of a vibrant, diverse, active, and truly international research community. We value interdisciplinarity, as it allows you to expand your research network and exposes you to new perspectives and ideas for solving complex research problems and pursuing novel research findings. We aim to prepare young life scientists for the new era of molecular, systems-oriented biosciences. LSM doctorates are given the opportunity to learn and master a variety of techniques. Furthermore, the graduate program holds various workshops and seminars to impart skills that are indispensable for every thoughtful and responsible scientist. The LSM coordination office, together with the student council and the LSM buddy support initiative, assists you with many administrative matters to ensure a smooth onboarding in Munich and at LMU.

Further information and details about the online application process, requirements and eligibility can be found here: www.lsm.bio.lmu.de/apply

Scientist I Mass Spectrometry Protein Analytics (gn)
Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 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 limited to 2 years position, to begin work as soon as possible. The mass spectrometry group of Formycon currently consists of five analysts and is equipped with two ESI-MS systems and one Orbitrap. Our area of activity is the characterization of biosimilars in a regulated environment. In this context, we perform routine analyses for e.g. similarity assessment, stabilities, process development. The powerful MS-systems in combination with a validated evaluation software (Waters_connect and Chromeleon) enables us to perform a broad method spectrum (peptide mapping, subunit analysis and intact mass).
Mass spectrometric routine measurements for the characterization of proteins
Improvement of MS-data evaluation and qualification of analytical methods
Independent evaluation and compliant documentation of experiments as well as compilation of development plans and reports
Qualification and maintenance of equipment and troubleshooting of technical problems

Master degree in a life science field or similar qualifications
Profound practical experience in mass spectrometry of proteins and peptides
Professional experience in the pharmaceutical/biotech industry, especially in a GMP/GLP-regulated environment is considered advantageous
Well organized person with ability to work independently and result-oriented
Very good team player with sound troubleshooting skills
Fluent in written and spoken English required, German knowledge is desirable
A work permit for Germany is mandatory

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!

quattro research ist ein interdisziplinäres Team von Wissenschaftlern und IT Spezialisten. Wir entwickeln innovative Lösungen und Produkte für unsere Kunden aus der Life Science-, Pharma- und Chemieindustrie.

Zur Verstärkung unseres Teams in München suchen wir eine(n)

Software Developer Life Science (m/w/d)
Sie programmieren im Team Software für Pharma-, Chemie- oder Biotech-Unternehmen. Entsprechend der Kunden und Projekte, werden bei uns eine Vielzahl an verschiedenen Techniken eingesetzt. Schwerpunkte sind dabei die Applikationsentwicklung mit Python, Java, Kotlin und JavaScript sowie die Datenbank-Entwicklung in Oracle oder PostgreSQL. Sie begeistern sich für die spannende Symbiose aus Life-Science und IT. Sie haben ein abgeschlossenes Studium der Informatik, Bioinformatik oder ein naturwissenschaftliches Studium mit Programmiererfahrung. Sie können sich rasch auf neue Aufgaben einstellen und sind unseren Kunden ein qualifizierter Ansprechpartner in allen Fragen des Datenmanagements.
Gute Englisch- und Deutschkenntnisse in Wort und Schrift runden Ihre Qualifikation ab. Eine Einarbeitung in angenehmer Arbeitsatmosphäre durch freundliche Kollegen. Wir bieten Ihnen einen interessanten und sicheren Arbeitsplatz. Flexible Arbeitszeiten sowie die Möglichkeiten zur Teilzeit sind für uns selbstverständlich. Durch Fortbildungen und Konferenzen unterstützen wir Sie in Ihrer persönlichen Weiterentwicklung.

We welcome applications via our website from 01 September - 13 October 2024.

The International Max Planck Research School for Molecules of Life (IMPRS-ML) offers fully funded PhD student positions in the areas of biochemistry, structural biology, biophysics, cell biology, systems biology, and computational biology. We are looking for outstanding graduates from all over the world to join our network of passionate young scientists in Munich.

The strongest asset of our graduate program is our vivid and international research community. IMPRS-ML brings together two renowned Max Planck Institutes, the MPI of Biochemistry and the MPI for Biological Intelligence, as well as two leading partner universities, the LMU and TUM, to deliver first-class training for the world’s most promising young scientists.

At IMPRS-ML, we are dedicated to pushing the boundaries of knowledge. Our research groups focus on exploring the structure, function, and dynamics of biomolecules. They investigate how and where these molecules interact in biological systems to generate appropriate responses to environmental cues.

More than 30 distinguished and internationally recognised group leaders actively participate in the PhD program and offer challenging and cutting-edge research projects in the following areas:

Biochemistry
Biophysics
Bio-imaging
Computational Biology
Gene Regulation
Immunobiology
Proteomics
Structural Biology
Signaling
Systems Biology
IMPRS-ML provides comprehensive scientific training in a superb and vibrant research environment with state-of-the-art facilities to students aiming for a successful career in science. Our doctoral researchers work within international teams of scientists in an interdisciplinary setting with extensive access to expertise and support. Seminars, summer schools, elective courses, career development training and participation in international conferences supplement laboratory work. We invite highly qualified candidates with a strong commitment to basic science to apply.

Applicants should hold an MSc (or equivalent degree) with a strong background in biological sciences, biochemistry, biophysics, biotechnology or a related discipline. Outstanding candidates with a first-class BSc degree (or equivalent degree) are eligible to apply for the fast-track option.

For more information, eligibility criteria and online application please visit our website: https://imprs-ml.mpg.de/
Excellent career opportunities in a vibrant international research community
A structured PhD program created by Munich-based Max Planck Institutes and Universities with English as the main language
State-of-the-art facilities and cutting-edge research projects
Individual supervision and mentoring by world-leading scientists
Full funding for international and German students, with no tuition fees and additional funding for scientific trainings and internships

Team Lead Regulatory Affairs CMC Drug Product (gn)


Manager First Level
Medicine, Pharmacy, Laboratory
Quality Management, Quality Assurance




Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 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. As Head of Regulatory Affairs CMC Drug Product you will be responsible for aligning and implementing regulatory strategies for Formycon’s product pipeline with regard to drug product development and manufacturing including design control aspects in the context of drug-device combination product development.

In this role you will lead a team of ≥ 5 RA managers. You will be acting as a regulatory expert coaching your team and aligning regulatory strategies with experts from various departments, external partners and CDMOs. Your reporting line is to the VP Regulatory Affairs and Quality Management. Your main tasks include the following:

Align RA CMC DP strategy for Formycon’s development projects and approved products (focus on aseptically manufactured parenteral products in various dosage forms) with project management, DP, device & packaging development departments and other RA CMC groups (DS and Analytics)
Review and align strategy for essential overarching concepts with focus on DP aspects (e.g. L&E studies, combination product development including design control, process characterisation and validation studies including transport validation) and define presentation in regulatory dossiers
Ensure timely preparation and appropriate review of regulatory documents for Briefing Books, IMPD/IND, BLA/MAA submissions and variation packages
Establish and implement strategies for drug-device combination products during development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the combination product development programs. Liaise with clinical department for design of human factor studies
Oversee preparation of documentation packages and submission to Notified Bodies for receipt of Notified Body Opinions according to Article 117 and coordinate establishment and maintenance of design history files
Guide RA CMC Drug Product team in defining the best strategy for each submission and their content
Support defining response strategies for requests from authorities in close collaboration with involved SME departments and CDMOs
Maintain knowledge of global competitive landscape, regulatory environment, and regulations with focus on drug product aspects including drug-device combination product development and design control
Participate in meetings with regulatory agencies (e.g. EMA, FDA)
Manage capacity allocation in team and coordinate regulatory CROs in charge of assigned work packages
Compile and maintain budget and capacity plans

Scientific background with master degree or PhD, preferably in biology, chemistry, biochemistry or equivalent
Minimum of 6 years work experience in Regulatory CMC area including experience with parenteral products and drug-device combination products
Thorough knowledge of the drug development process with demonstrated experience in multiple development phases up to submission
Experience with drug-device combination products...

We welcome applications via our website from 01 September - 13 October 2024.

The International Max Planck Research School for Molecules of Life (IMPRS-ML) offers fully funded PhD student positions in the areas of biochemistry, structural biology, biophysics, cell biology, systems biology, and computational biology. We are looking for outstanding graduates from all over the world to join our network of passionate young scientists in Munich.

The strongest asset of our graduate program is our vivid and international research community. IMPRS-ML brings together two renowned Max Planck Institutes, the MPI of Biochemistry and the MPI for Biological Intelligence, as well as two leading partner universities, the LMU and TUM, to deliver first-class training for the world’s most promising young scientists.

At IMPRS-ML, we are dedicated to pushing the boundaries of knowledge. Our research groups focus on exploring the structure, function, and dynamics of biomolecules. They investigate how and where these molecules interact in biological systems to generate appropriate responses to environmental cues.

More than 30 distinguished and internationally recognised group leaders actively participate in the PhD program and offer challenging and cutting-edge research projects in the following areas:

Biochemistry
Biophysics
Bio-imaging
Computational Biology
Gene Regulation
Immunobiology
Proteomics
Structural Biology
Signaling
Systems Biology
IMPRS-ML provides comprehensive scientific training in a superb and vibrant research environment with state-of-the-art facilities to students aiming for a successful career in science. Our doctoral researchers work within international teams of scientists in an interdisciplinary setting with extensive access to expertise and support. Seminars, summer schools, elective courses, career development training and participation in international conferences supplement laboratory work. We invite highly qualified candidates with a strong commitment to basic science to apply.

Applicants should hold an MSc (or equivalent degree) with a strong background in biological sciences, biochemistry, biophysics, biotechnology or a related discipline. Outstanding candidates with a first-class BSc degree (or equivalent degree) are eligible to apply for the fast-track option.

For more information, eligibility criteria and online application please visit our website: https://imprs-ml.mpg.de/
Excellent career opportunities in a vibrant international research community
A structured PhD program created by Munich-based Max Planck Institutes and Universities with English as the main language
State-of-the-art facilities and cutting-edge research projects
Individual supervision and mentoring by world-leading scientists
Full funding for international and German students, with no tuition fees and additional funding for scientific trainings and internships

Team Lead Regulatory Affairs CMC Drug Product (gn)


Manager First Level
Medicine, Pharmacy, Laboratory
Quality Management, Quality Assurance




Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 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. As Head of Regulatory Affairs CMC Drug Product you will be responsible for aligning and implementing regulatory strategies for Formycon’s product pipeline with regard to drug product development and manufacturing including design control aspects in the context of drug-device combination product development.

In this role you will lead a team of ≥ 5 RA managers. You will be acting as a regulatory expert coaching your team and aligning regulatory strategies with experts from various departments, external partners and CDMOs. Your reporting line is to the VP Regulatory Affairs and Quality Management. Your main tasks include the following:

Align RA CMC DP strategy for Formycon’s development projects and approved products (focus on aseptically manufactured parenteral products in various dosage forms) with project management, DP, device & packaging development departments and other RA CMC groups (DS and Analytics)
Review and align strategy for essential overarching concepts with focus on DP aspects (e.g. L&E studies, combination product development including design control, process characterisation and validation studies including transport validation) and define presentation in regulatory dossiers
Ensure timely preparation and appropriate review of regulatory documents for Briefing Books, IMPD/IND, BLA/MAA submissions and variation packages
Establish and implement strategies for drug-device combination products during development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the combination product development programs. Liaise with clinical department for design of human factor studies
Oversee preparation of documentation packages and submission to Notified Bodies for receipt of Notified Body Opinions according to Article 117 and coordinate establishment and maintenance of design history files
Guide RA CMC Drug Product team in defining the best strategy for each submission and their content
Support defining response strategies for requests from authorities in close collaboration with involved SME departments and CDMOs
Maintain knowledge of global competitive landscape, regulatory environment, and regulations with focus on drug product aspects including drug-device combination product development and design control
Participate in meetings with regulatory agencies (e.g. EMA, FDA)
Manage capacity allocation in team and coordinate regulatory CROs in charge of assigned work packages
Compile and maintain budget and capacity plans

Scientific background with master degree or PhD, preferably in biology, chemistry, biochemistry or equivalent
Minimum of 6 years work experience in Regulatory CMC area including experience with parenteral products and drug-device combination products
Thorough knowledge of the drug development process with demonstrated experience in multiple development phases up to submission
Experience with drug-device combination products...