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Senior Regulatory CMC specialist (Biologics) - Slovak Republic

Company: AXON Neuroscience R&D Services SE
Location: Bratislava, Slovak Republic
Reference: CMCP181
Closing Date: 08 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

AXON Neuroscience is a clinical-stage biotech company founded in 1999 in Austria. AXON employs a globally largest team of researchers focused exclusively on tau-immunotherapies and tau diagnostic platforms.

Requirements:

Company profile:

AXON Neuroscience is a clinical-stage biotech company founded in 1999 in Austria. AXON employs a globally largest team of researchers focused exclusively on tau-immunotherapies and tau diagnostic platforms. AXON owns several compounds with disease-modifying as well as early diagnostic potential for Alzheimer’s disease and other tauopathies with focus to bring a complex solution for people suffering from these devastating diseases. The two leading assets are the phase 2 active vaccine AADvac1 in AD and nfvPPA and a pre-clinical humanized monoclonal antibody AADvac2. AADvac1 is currently the most advanced tau drug candidate available to AD patients.

 

Requirements:

  • At least a Master's Degree or PhD preferred
  • At least 5 years of experience with pharmaceutical development of biologics

Regulatory

  • Extensive experience with Biologic CMC regulatory documents (MAA, BLA, CMC documentation for IND/CTAs, supplements), with FDA and EMA meetings (meeting documentation preparation and briefing books responses)
  • Practical knowledge of FDA, EMA and ICH guidelines, specifically focused on CMC regulations for biological compounds

Manufacture

  • Expertise in the late stage biologics development process (process validations) and approval activities
  • Extensive experience with manufacture of biologics, preferentially monoclonal antibodies, antibody-drug conjugates and peptide drug conjugates;
  • Experience with protein biochemistry, conjugation chemistries and specific structural and functional requirements of biologics
  • Understanding of analytical methods used for monoclonal antibodies and other biologics (HPLC, LC-MS/MS, MALS, etc.)

Personality

  • Have a solution-oriented approach to problem solving
  • Ability to lead complex projects and multi-disciplinary teams

 

Responsibilities include, but are not limited to:

  • Responsible for guidance of biologics manufacture at CMO
  • Responsible for implementing CMC regulatory strategies for assigned biologics in accordance with global/appropriate regulations, guidances and defined regulatory strategies.
  • Responsible for the preparation and review of information required for regulatory CMC dossiers for biologics.
  • Provide input to development of biologics and critically evaluate manufacturing process and supporting documentation to assess acceptability and identify potential risks.
  • Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation.
  • Provide input to selection and development of analytical methods for quality standards and characterization of biological drug candidates;

 

Notes:

Place of work: Bratislava, Slovak Republic

Days in office: 3 days weekly

Apply for this job: Senior Regulatory CMC specialist (Biologics) - Slovak Republic

Contact Information:

Address:  Head Office
Dvorakovo nabrezie 10
Bratislava
811 02
Slovakia
Tel:  421220921620
Website:  Visit Our Web Site

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