Director Physicochemical Analytics

Job content

Do you have several years of experience in development management in the biotech industry ? Do you have an in -depth understanding of the scientific aspects involved in large molecules development ? You should then have a look at the following lines!

One of clients, specialized in biopharma and based in the Vaud canton, is looking for a Director Physicochemical analytics with a permanent contract.

Your Tasks

• Become accountable for the global strategy of physicochemical analytics and formulation development for biosimilar entities from project initiation up to product commercialization
• Ensure delivery of compliant physicochemical analytics and formulation packages to development teams, take accountability for their implementation by department members, labs, CROs and CMOs according to quality, timelines and cost
• Ensure support of regulatory function via the contribution to regulatory interactions and documents (IND/IMPD, CTAs, submissions) during development and commercial phase
• Support physicochemical analytics laboratory (mass spectrometry, liquid chromatography, capillary electrophoresis, ELISA, PCR, spectrophotometry) in method development ensuring high competency and quality standard to optimally support biosimilar projects
• Build and maintain scientific excellence, technical expertise and data integrity in the area of responsibility. Remain abreast of new developments in the biosimilar field and build strong reputation within the industry community
• Build and sustain strong interface with CROs and CMOs critical to the success of biosimilar development, ensuring development, validation and tech transfer of analytics as per project needs
• Ensure that biosimilar “mindset” and specialized requirements are communicated and adhered to by the dedicated internal and external resources
• May serve as a member of biosimilars development teams and/or CMC teams
• Build and sustain trust and transparency with key internal colleagues (RDMS, Project Management, Regulatory Affairs, Quality) and external customers (CROs, CMOs, collaborators, consultants) to ensure engagement with the Biosimilars team objectives
  

Your Profile

• Advanced scientific degree: PhD in analytical chemistry or equivalent, or Master degree with significant post-graduate experience
• Minimum of 10 years experience, with management responsibilities, in R&D in the biopharma industry, preferably with biosimilars. People management experience an advantage
• In depth experience in analytical sciences applied to proteins / mAbs and familiar with state of the art biochemical and biophysical analytical methods to determine primary, secondary and tertiary structure, purity/impurity, glycosylation, post-translational modifications, process-related contaminants, compendial testing and to support formulation development
• Fluency in English essential, both oral and written; additional languages (French) are an asset
• Significant exposure to / understanding of cross-functional CMC development of biotherapeutics
• Track record of successful interactions with Health Authorities in highly regulated markets
• Demonstrated success operating in a global matrix organization with the full breadth of functions contributing to drug development
• Experience of Physchem analytics through product development life cycle from clone development to QC release and commercial supply
• Management competencies
• Results orientation
• Communication and interpersonal skills
  

Does that sound like a match? Apply now to your next adventure!