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Manufacturing Sciences Upstream Process Technology
vor 1 Woche
Manufacturing Sciences Upstream Process Technology Lead
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JOB PURPOSE:
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As a key leader in Upstream Process Technologies you join the Global Manufacturing Sciences Department at the Drug Substance biologics manufacturing site to oversee all USP Process Transfer & Sciences activities.
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.
MAIN TASKS:
- Key technical leader in USP process technologies, accountable for coorindation of technical and laboratory activities in support of technology transfer, continued cGMP manufacturing & process improvements.
- Provides guidance and coordinates USP Process Transfer & Sciences SME activities incl. GMS lab operations & studies. Establish efficent workflows.
- Leads crossfunctional project teams to enable process transfer, validation & process life cylce activities.
- Accountable for technical manufacturing support through process monitoring, resolution of technical issues & participation in operations governance huddles.
- Leads technical process investigations, rootcause analysis and definition of appropriate corrective measures & effectiveness checks. Author and assess change controls.
- Authors technical protocols/reports for process performance qualification, continued process verification, investigations, and regulatory submissions.
- Trends & analyses process data to guide & implement advancements of USP process technologies, process robustness & productivity initiatives.
- Communicates project/campaign/technical status to stakeholders and leadership while assuring alignment with strategic goals and site priorities.
WHAT YOU NEED AS SUCCESSFUL CANDIDATE:
- 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 stateof 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.
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