Director Physicochemical Analytics (m/f/d), Eysins

Fresenius Kabi Deutschland GmbH

Fresenius Kabi ist ein weltweit tätiges Gesundheitsunternehmen, das Medikamente und Medizinprodukte zur Infusion, Transfusion und klinischen Ernährung anbietet. Unsere Produkte und Dienstleistungen werden in der Therapie und Versorgung von kritisch und chronisch kranken Patienten eingesetzt.

Your assignments

  • 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 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

EDUCATION & LANGUAGES:

  • Advanced scientific degree: PhD in analytical chemistry or equivalent, or Master degree with significant post-graduate experience
  • Fluency in English essential, both oral and written; additional languages (French) are an asset

PROFESSIONAL SKILLS & EXPERIENCE:

  • Minimum of 10 years experience, with management responsibilities, in R&D in 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
  • 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

PERSONAL SKILLS & COMPETENCIES:

  • Management competencies: Build relationship, set goals, track progress, guide other leaders and delegate effectively. Achieve organizational focus on key priorities and demonstrate good judgment and business maturity to make sound decisions. Maintain a culture of active communication about performance, team orientation, accountability and commitment. Encourage staff development via on-the-job learning, coaching and training. Achieve agreement on key priorities and be effective in influencing management and peers to maximize opportunities. Lead and manage change.
  • Results orientation: Establish clear expectations and focus resources on key priorities. Deliver consistent performance with continual monitoring. Be flexible and responsive to change, able to manage priorities and deliver under pressure, and demonstrate creative problem-solving skills. Be decisive and action-oriented. Work effectively in a team-based organization, listen well, collaborate cross-functionally and readily build alignment.
  • Communication and interpersonal skills: Ability to simplify and convey complex concepts and strategies, orally and in writing. Chair meetings effectively and ensure discussions are advanced appropriately. Strong presentation skills, along with good listening skills. Seek broad input and feedback and apply effective follow-up. With a high level of confidence and savvy, be able to represent Fresenius-Kabi externally

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