Mfg Scientist II, Downstream Process Transfer
Mfg Scientist II, Downstream Process Transfer
Biogen
Luterbach, Switzerland
About This Role
As our Mfg Scientist II Downstream Process transfer you will provide key technical subject matter expertise to Downstream process transfer & process sciences activities to support technology transfer & operations at the Solothurn Drug Substance manufacturing facility. Assignments may vary per overall MS team and site requirements.
What You'll Do
- Lead cross-functional process transfer sub-teams for new product introduction, PPQ or restart campaigns;
- Provide support & technical leadership to operations by leading complex process related investigations, impact assessments, CAPAs & GCCs;
- Lead design and execute process science lab studies to support facility fit, campaigns, investigations, and innovation;
- Perform data analysis to support process science studies, process consistency and improvements;
- Author and review technical protocols & reports for process validation, investigations, process sciences studies and regulatory commitments;
- Translate and guide cross-functional stakeholders in process knowledge.
Who You Are
You are a highly experienced technical expert in downstresm drug substance manufacturing operations and process sciences. You excel in coordinating technical expertise and leading cross-functional project teams to align with strategic goals and site priorities. You are self-driven with the desire to make a positive impact to peers, processes & patients.
Qualifications
- PhD, MSc or BSc in Biochemistry, Chemistry, Chemical or Bioprocess Engineering, Biology, or closely allied discipline. (BS with at least 8 years experience or MS with at least 4 years experience or PhD with at least 2 years experience);
- Deeply understands process descriptions and process control strategies;
- Masters process technology processes;
- Understands operational quality concepts and masters usage of quality management systems;
- Knowledgeable regarding manufacturing execution systems (Syncade and Delta V);
- Fully understands cGMP requirements and applies these requirements to all situations;
- Excellent investigational and writing skills;
- Communicates openly and honestly with others in both oral and written forms;
- Provides guidance and training to co-workers and supports team goals by example;
- English - minimum B1.
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