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- Aufgaben: Lead cross-functional teams in upstream process technologies and oversee technical support for manufacturing.
- Arbeitgeber: Join a leading Worldwide Biotech company in the Bern area, making an impact in drug substance manufacturing.
- Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Warum dieser Job: Be a key player in advancing bioprocess technologies and improving manufacturing processes.
- Gewünschte Qualifikationen: Requires a relevant degree and extensive experience in upstream bioprocess technologies and project management.
- Andere Informationen: Ideal for experienced technical experts who thrive in dynamic, team-oriented settings.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
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 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 incl. 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 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 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 area 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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Head Of Global Indirect Operational Procurement (M / F / D) Arbeitgeber: Mid-sized company specializes in industrial connection and networking technologies
Kontaktperson:
Mid-sized company specializes in industrial connection and networking technologies HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Head Of Global Indirect Operational Procurement (M / F / D)
✨Tip Number 1
Make sure to highlight your experience with upstream bioprocess technologies in your conversations. This role requires a deep understanding of these technologies, so be prepared to discuss specific projects where you've successfully implemented or improved these processes.
✨Tip Number 2
Demonstrate your project management skills by sharing examples of how you've led cross-functional teams in the past. This will show that you can effectively coordinate activities and drive results in a collaborative environment.
✨Tip Number 3
Familiarize yourself with cGMP and FDA/EMA compliance regulations, as this knowledge is crucial for the role. Be ready to discuss how you've navigated regulatory challenges in previous positions.
✨Tip Number 4
Prepare to communicate your technical expertise clearly and confidently. Strong presentation and communication skills are essential, so practice explaining complex concepts in a way that is easy to understand for stakeholders.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Head Of Global Indirect Operational Procurement (M / F / D)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the Head Of Global Indirect Operational Procurement position. Tailor your application to highlight your relevant experience in upstream bioprocess technologies and project management.
Highlight Relevant Experience: In your CV and cover letter, emphasize your technical expertise in upstream drug substance manufacturing operations. Provide specific examples of your experience with process transfers, validation, and leading cross-functional teams to demonstrate your suitability for the role.
Showcase Technical Writing Skills: Since the role involves authoring technical documents and reports, include examples of your technical writing in your application. This could be previous reports, protocols, or any documentation that showcases your ability to communicate complex information clearly.
Prepare for Regulatory Knowledge: Given the importance of cGMP and FDA/EMA compliance in this role, be prepared to discuss your practical knowledge and experiences related to regulatory inspections. Highlight any interactions you’ve had with inspectors or agency personnel in your application.
Wie du dich auf ein Vorstellungsgespräch bei Mid-sized company specializes in industrial connection and networking technologies vorbereitest
✨Showcase Your Technical Expertise
Be prepared to discuss your experience with upstream bioprocess technologies in detail. Highlight specific projects where you led process transfers or improvements, and be ready to explain the technical challenges you faced and how you overcame them.
✨Demonstrate Leadership Skills
Since this role involves leading cross-functional teams, share examples of how you've successfully managed teams in the past. Discuss your approach to guiding team members through complex projects and how you ensure alignment with strategic goals.
✨Prepare for Regulatory Discussions
Given the importance of compliance in this role, familiarize yourself with cGMP and FDA/EMA regulations. Be ready to discuss your experience with regulatory audits and how you've navigated inspections in previous roles.
✨Communicate Effectively
Strong communication skills are crucial for this position. Practice articulating your thoughts clearly and concisely, especially when discussing technical issues or project statuses. Consider preparing a few key points to convey your ideas effectively during the interview.
