Global Drug Substance Lead
Sandoz Canada
Kundl, Austria
vor 2 Tg.

Position purpose :

Lead late-phase drug substance (DS) process development and process transfer activities, provide scientific support within Drug Substance Lead group, Schaftenau / Kundl area.

Major accountabilities / area of responsibilities :

  • Provide scientific leadership for various late-phase drug substance development activities, e.g. process characterization;
  • manufacturing process transfers.

  • Collaborate closely with key stakeholders, interfaces within the organization and maintain efficient communication towards them.
  • Write / lead / review defined development related documentation, e.g. characterization studies, transfer protocols, reports; control strategy documents.
  • Lead / contribute to various DS development related or project management related meetings, e.g., CMC meetings, troubleshooting meetings.
  • Contribute to responses for health authorities, support audits and inspections.
  • Ensure that the right and consistent development resources are applied, contribute / support achieving top performance.
  • Contribute to continuous improvement of scientific knowledge and approaches.
  • Ensure, strengthen the application of harmonized standards, relevant SOPs.
  • Minimum :

  • Advanced degree in life sciences.
  • Minimum 5 years of experience from biotechnology / pharmaceutical environment.
  • Excellence in English (oral and written).
  • Desirable :

  • Ph.D. in scientific discipline (e.g. Bio-or chemical engineering, pharmacy, chemistry), preferably with focus on biopharmaceutical processes.
  • Excellent communication skills in English (oral & written); German knowledge is a plus.
  • Experiences and solid understanding of biologics DS development and / or large-scale manufacturing processes.
  • Experiences with Pre-Approval Inspections, reviewing submission documents to health authorities, and knowing GMP is a key advantage.
  • Excellent organizational skills, team player, flexible and dedicated personality.
  • Demonstrated skills working in cross-functional / international environment.
  • Ability to coordinate a number of tasks simultaneously, prioritize and deliver against tight timelines.
  • Ability to design / evaluate / summarize / report upstream and downstream development studies, DoEs.
  • Ability to lead / facilitate meetings composed of cross-functional experts.
  • Excellent problem solving mind-set, attitude to resolve challenges, interdisciplinary thinking.
  • Ability of properly balancing between efforts, risks and benefits.
  • Please apply online (Job ID 249235BR)

    Contact : Marcel Otto, Talent Acquisition & Staffing Business Partner

    We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.

    The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 54.960 per year).

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