About this role
Job title: Lead Process Experts TechOps (MSAT) - Sisslerfeld Site Development 100% (a)
About the Role Lead Process Expert TechOps (MSAT) will join Bachem's Greenfield GMP-regulated downstream API production site at Sisslerfeld to drive the setup and development of processes and structures at the interface of production, Quality, Engineering and Project Management. You will own the receiving unit for process transfers, drive technology transfers and qualification activities, and support commissioning and site development.
What You'll Do
- Plan, build, lead and develop the TechOps organization for the site development project.
- Take on the fachliche Verantwortung as the "receiving unit" for process transfers into production and ensure transfer readiness.
- Conduct GMP assessments and create/implement transfer plans.
- Prepare, coordinate and execute Process Performance Qualification (PPQ).
- Create GMP assessments and risk analyses to support risk-based decision making.
- Support scale-up evaluations and process reviews during equipment and process development.
- Accompany the commissioning of new equipment and systems and support qualification campaigns.
- Establish and document TechOps business processes aligned with site development.
- Provide technical support to production on process questions and deviation analysis.
- Collaborate closely with Manufacturing, TechOps, Engineering, QA and Project Management.
- Assist during regulatory inspections and customer audits in the build/start-up phase.
What We're Looking For
- Completed university degree in Chemistry, Pharmaceutical Chemistry, Biotechnology or a comparable engineering/science discipline; ideally with a PhD.
- Several years of experience in large-scale downstream or upstream processing of APIs in a GMP-regulated environment.
- Solid knowledge of preparative chromatography; experience with freeze-drying and spray-drying is a plus.
- Strong knowledge in chemical production, process engineering, plant design and regulatory requirements (ICH Q7, FDA, EMA).
- Experience planning and conducting Tech Transfers; structured and solution-oriented with the ability to pragmatically solve problems in complex/unclear situations.
- Team-oriented personality with clear, open communication and the ability to bring interfaces together.
- Very good German and English language skills in written and spoken form.
Nice to Have
- PhD (promotion) is desirable.
Compensation & Benefits
- Dynamic and fast-growing work environment with internal development and continuous training opportunities.
- Flexible working hours with the possibility of home office and option for additional vacation days with reduced workload.
- Company kindergarten on the Bachem campus and other family-friendly benefits.
- 60% of pension contributions paid by Bachem AG with option for additional retirement provision via our Wahlsparplan.
- Access to partner discount programs and benefits platforms.
- Fresh, healthy and varied meals in the employee restaurant and a variety of free sports activities on the campus.