Upstream Process Technology Lead
vor 2 Wochen
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.Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.
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