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Senior Manager, Manufacturing Sciences Upstream, Bern Client: Recrutis
Location: Bern
Job Category: Other
Job Reference: 446ff13b08e6
Job Views: 3
Posted: 14.03.2025
Expiry Date: 28.04.2025
Job Description: For one of our clients, a leading Worldwide Biotech company in the Bern area, we are currently looking for a Manufacturing Sciences Upstream Process Technology Lead .
JOB PURPOSE:
As a key leader in Upstream Process Technologies, you will join the Global Manufacturing Sciences Department at the 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.
MAIN TASKS:
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.
Provides guidance and coordinates USP Process Transfer & Sciences SME activities including GMS lab operations & studies. Establish efficient workflows.
Leads 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.
Leads technical process investigations, root-cause 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 A 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 state-of-the-art upstream bioprocess technologies (including PAT) & manufacturing operations.
Proven project management experience and capability to work effectively in a team environment.
Good interpersonal skills, with the ability to influence behaviours, 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.
If you are a highly experienced technical expert in upstream drug substance manufacturing operations and process sciences and like leading projects with cross-functional teams, this role is for you!
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