Sr. Manager, Upstream Process Technology

Biogen

Luterbach, Switzerland

About This Role

As Sr. Manager, Upstream Process Technology you will join the Global Manufacturing Sciences Department at the Solothurn drug substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities. You will 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 will coordinate daily activities & provide scientific leadership for lab studies to advance process understanding, support investigations & drive process improvements. You will 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.

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 think broadly, considering the bigger picture while navigating complex challenges, and you drive results by ensuring that every action contributes to achieving measurable outcomes. You are self-driven with the desire to make a positive impact on peers, processes, and patients.

Qualifications

Required Skills

Bachelor's degree in a relevant technical discipline with a minimum of 10 years of relevant experience;
Master's degree in a relevant technical discipline with a minimum of 8 years of relevant experience;
PhD in a relevant technical discipline with a minimum of 4 years of relevant experience;
Extensive experience in manufacturing operations within pharmaceutical or biotech facilities, with a strong background in cell culture technology;
In-depth technical expertise in advanced upstream bioprocess technologies, including Process Analytical Technology (PAT) and manufacturing operations;
Demonstrated project management experience with a proven ability to lead and collaborate effectively within a team environment;
People management experience;
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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