Team Leader, Downstream Process Development (m/f) DSP Development, Biopharmaceuticals, Sandoz GmbH, Schaftenau
Area of Responsibility
- Lead, manage and develop a downstream process development team; supervise and manage all development activities in accordance with budgets, project plans, and safety requirements.
- Planning, leading and managing all downstream development activities and projects (Biosimilars and new Biopharmaceuticals) in accordance with timelines and resources and by applying QbD elements.
- Oversee preparation of relevant source documents such as development reports, risk assessments, study plans and reports.
- Participate in technical sub teams and fulfill assigned project tasks and responsibilities Ensure appropriate qualification status to ensure that all development data generated meets the regulatory agencies’ expectations, and industry best practice.
- Carry out implementation of and compliance with development standards as described in development manuals, SOPs and regulatory guidelines.
- Education: University degree in life sciences (e.g. Biotechnology, Chemistry, Biochemistry or equivalent)
- Languages: English (fluent) / German (beneficial)
- Experience: At least 4 years (2 years with PhD) of work related industrial experience