Upstream Process Technology Lead

Upstream Process Technology Lead

Biogen

Luterbach, Switzerland

About This Role

As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities.

You lead cross-functional teams to facilitate new product introduction, process transfers, validation and advance process technologies. You will oversee technical support for manufacturing campaigns, and provide leadership in addressing process deviations & change controls.

As part of a talented team of Process Engineers & Scientists, you coordinate daily activities & provide scientific leadership for lab studies to advance process understanding, support investigations & drive process improvements. You author and review technical documents, lead engagements during regulatory audits & filings and communicate project & technical issues.

What You'll Do

  • Key technical leader in USP process technologies, accountable for coordination of technical and laboratory activities in support of technology transfer, continued cGMP manufacturing & process improvements;
  • Provide guidance and coordinates USP Process Transfer & Sciences SME activities incl. GMS lab operations & studies. Establish efficient workflows;
  • Lead cross-functional project teams to enable process transfer, validation & process life cycle activities;
  • Accountable for technical manufacturing support through process monitoring, resolution of technical issues & participation in operations governance huddles;
  • Lead technical process investigations, root-cause analysis and definition of appropriate corrective measures & effectiveness checks. Author and assess change controls;
  • Author technical protocols/reports for process performance qualification, continued process verification, investigations, and regulatory submissions;
  • Trend & analyze process data to guide & implement advancements of USP process technologies, process robustness & productivity initiatives;
  • Communicate project/campaign/technical status to stakeholders and leadership while assuring alignment with strategic goals and site priorities.

Qualifications

Who You Are

You are a highly experienced technical expert in upstream 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.

Required Skills

  • Educational Qualification: Degree in relevant technical discipline - Either a Bachelor's degree plus 10 years of relevant experience, a Master's degree plus 8 years of relevant experience or a PhD plus 4 years of relevant experience;
  • Excellent technical experience with state-of the art upstream bioprocess technologies (incl. PAT) & manufacturing operations;
  • Proven project management experience and capability to work effectively in a team environment;
  • Good interpersonal skills, with the ability to influence behaviors, negotiate, and resolve challenges with poise, tact, and diplomacy;
  • Strong data analysis, technical writing, presentation and communication skills;
  • Practical knowledge and application of cGMP and FDA/EMA compliance regulations and inspections, with experience interfacing with inspectors and/or agency personnel.

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