For one of our clients, a leading Worldwide Biotech company in 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 join the Global Manufacturing Sciences Department at the 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.

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 cross-functional 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, 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 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 (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.

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!