Senior Manager, Manufacturing Sciences Upstream

TN Switzerland; Bern; Vor Ort; CHF 100’000 - 150’000; Vollzeit

Zusammenfassung

An established industry player in the biotech sector is seeking a Senior Manager for Manufacturing Sciences Upstream. This pivotal role involves leading cross-functional teams to drive process transfers, validation, and improvements at a biologics manufacturing site. You will provide technical leadership, oversee laboratory activities, and ensure compliance with cGMP and regulatory standards. If you are passionate about advancing bioprocess technologies and thrive in a collaborative environment, this opportunity is perfect for you. Join a dynamic team and make a significant impact in the field of drug substance manufacturing.

Qualifikationen

• Degree in relevant technical discipline with extensive experience in upstream bioprocess technologies.
• Proven project management experience and strong data analysis skills.

Aufgaben

• Lead cross-functional teams for process transfer and validation activities.
• Oversee technical support for manufacturing campaigns and process improvements.

Kenntnisse

Upstream bioprocess technologies

Project management

Data analysis

Technical writing

Interpersonal skills

Ausbildung

Bachelor's degree in relevant technical discipline

Master's degree in relevant technical discipline

PhD in relevant technical discipline

Tools

cGMP compliance

FDA/EMA compliance

Jobbeschreibung

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Senior Manager, Manufacturing Sciences Upstream, Bern

Client:

Recrutis

Location:

Bern

Job Category:

Other

Job Reference:

446ff13b08e6

Job Views:

2

Posted:

18.04.2025

Expiry Date:

02.06.2025

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. Establishes 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. Authors and assesses 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!