The Consultant CMC is the quality expert in the Granzer team, providing knowledge on broad range of drug substances (from small molecules to synthetic oligonucleotides to biologicals) and drug products (from solid orals to sterile solutions to nanoparticulate formulations). This function will cover all quality related topics from pre-clinical development to approved commercial products.

 

Tasks & Responsibilities:

 

 

• Provide advice to clients on quality aspects of drug development and regulatory requirements, in close collaboration with cross-functional experts from the team

• Ensure that the content of CMC work-packages and documentation are phase appropriate, meet regulatory expectations and enable approval of regulatory submissions

• Preparation of quality sections for MAA and BLA/NDA as well as for IMPD and IND

• Perform gap analyses of client-provided packages. Identify critical CMC development issues and develop strategies for their resolution

• Support due diligence processes

• Prepare briefing packages for agency meetings (e.g. scientific advice, oral explanation, EoP2) and conduct such meetings together with the client

• Management of operational and strategical aspects with CDMOs

• Coordination of filing activities within the cross-functional Granzer team and with contributing parties

• Continued observance of regulatory guidance and regulations

 

Requirements:

 

• Ph.D. or master’s degree in Pharmacy, Chemistry, Biopharmaceuticals, Biochemistry, Biology or comparable

• At least five years in a scientific/technical CMC development or CMC – regulatory affairs function

• Experience with regulatory filings (IND/IMPD, BLA/NDA/MAA).

• Excellent communication and negotiation skills in English. German language skills are a plus

• Experience with CMC and regulatory requirements for all development stages, from pre-clinical to Phase III or commercial

• Highly motivated team player with strong interpersonal abilities

• Sound knowledge of Microsoft Office applications

• Willingness to travel moderately (Meetings with clients, agencies or CMOs)

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team, we provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz

 

 

The Consultant “Medical Device” supports the device parts of drug-device combination products, In Vitro diagnostics and companion diagnostics in a drug development environment.

 

Tasks & Responsibilities:

 

• Provide advice to clients on technical, quality, clinical aspects of drug-device combination product development in close collaboration with cross-functional experts from the team.
• Ensure that content of medical device work-packages and documentation are appropriate and enable CE certification and perform gap analyses for regulatory compliance.
• Support Notified Body submissions (including NBOp as per MDR Art. 117, clinical investigation, 510(k))
• Preparation of device-related module-3 sections for MAA and BLA/NDA submissions of drug-device combination products regulated as medicinal products
• Prepare briefing packages for meetings with Notified Bodies and agencies and conduct such meetings together with the client
• Management of operational and strategical aspects with CMOs

 

Requirements:

 

• Ph.D. or master’s degree and at least five years experience in the field including experience in drug development
• Experience with regulatory filings (technical documentation for CE-certification & STED/application for clinical investigations/pre-RFD/RFP/IDE/De Novo/510(k)/PMA)
• In depth understanding of medical devices (MDR, IVD, IVDR; 21 CFR Part 820) and QA (ISO 13485)
• Experience with medical devices and regulatory requirements for all device life-cycle stages and with relevant processes including risk management and usability engineering
• Team player with strong interpersonal abilities and excellent communication skills in English.

 

We offer:

A professional and friendly working environment located in Munich. Working together with a dedicated small and effective team. We provide an outstanding and more than competitive salary, with a very attractive bonus system tailored to your expertise and our business success.

 

Contact:

If you are interested please send your application documents to Dr. Stefan Blesse, blesse@granzer.biz