NBE/ATMP CMC Expert

Boehringer Ingelheim

NBE/ATMP CMC Expert

Boehringer Ingelheim

Biberach, Germany

OUR COMPANY

At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

THE POSITION

A lot to do despite Corona! Boehringer Ingelheim is still looking for new colleagues!

For our Research & Development (R&D) project teams for biologicals from hand-over from Research up to launch in major markets, we are looking for an NBE/ATMP CMC expert. With your expert knowledge and relevant industry experience in CMC development of biologicals you make a critical contribution to Boehringer Ingelheim.

Tasks & responsibilities

  • You are acting as CMC Expert for BI´s NBE/ATMP development projects in R&D project teams from hand-over from Research until launch in major markets;
  • In close collaboration with project management and individual biologicals CMC development functions, you leverage your cross-functional scientific/technical expertise in biologicals development as well as your sound knowledge of global regulatory guidelines to drive projects’ cross-functional CMC content proactively;
  • As an expert in the field of biologicals, you ensure that the content of CMC work-packages and documentation are phase appropriate, meet state of the art regulatory expectations and enable smooth approvals of regulatory submissions by considering current and evolving regulatory requirements;
  • Moreover, you identify critical CMC development issues and proactively drive strategies and implementations for their resolution;
  • You are closely working together with CMC Regulatory Affairs ensuring alignment regarding regulatory questions and strategies.

Requirements

  • Ph.D. in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry or Biology;
  • Several years of industry experience in different scientific/technical CMC development functions (cell line, process, pharmaceutical and/or analytical development) and/or in CMC regulatory affairs in a biopharmaceutical development organization;
  • In depth CMC development knowledge of antibodies/antibody-derived formats and oncolytic viruses/gene therapy products across the different stages of drug development;
  • Experience with global regulatory filings for biologicals (IND/IMPD, BLA/MAA);
  • Excellent communication and negotiation skills and ability to clearly and concisely communicate complex technical matters to senior management.

EFFECTS OF COVID-19

We will continue to hire talented people and we look forward to receiving your applications. As a result of COVID-19, we have introduced alternative working arrangements to ensure that our employees can stay safe and healthy, because the health of our employees is among our top priorities. At all company locations, we work remotely whenever possible. Additionally, we are now hosting virtual video interviews for applicants. During the limited in-person interviews we still have during this time, we pay special attention to distance and the hygiene rules recommended by the Robert Koch Institute. New employees who do not start on site in production or the laboratories are sent the necessary IT equipment, our Welcome Days take place online, and we plan to conduct their onboarding training virtually whenever possible.

WHY BOEHRINGER INGELHEIM?

This is where you can grow, collaborate, innovate and improve lives.

We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance. Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy. To learn more about what benefits could be waiting for you, please visit our Career area.

Want to learn more about us? Visit https://www.boehringer-ingelheim.com/.

Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

READY TO CONTACT US?

Please contact our Recruiting EMEA Team: Benjamin Witte, Tel: +49 (7351) 54-176426.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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