MSAT Process Lead
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Job Location:
Delémont - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Our offer
Role summary
- Provide technical leadership within Manufacturing Science and Technology by defining and maintaining the processes as part of Tech transfer / NPI activities such as
- ICH-Q3 risk assessments and testing strategies
- Establishment of an endtoend process for materials management (raw materials process consumables singleuse components).
- Translate GMP and regulatory expectations into robust risk management strategies ensuring compliance and reliable manufacturing & supply.
Your mission
Key responsibilities
Lead and author ICH Q3 risk assessments:
Cross-functional leadership:
Lead and author ICH Q3 risk assessments:
- Perform risk identification quantification and control strategy definition for processrelated impurities derived from materials of construction of product contact materials.
- Define and justify risk monitoring testing strategies using ICH Q9 principles and product knowledge.
- Own the lifecycle of process materials from specification through qualification use and change control.
- Establish material requirements and critical attributes; create critical materials qualification protocols and reports i.e for single use systems (SUS).
- Implement whenever necessary dual sourcing or alternate materials and identify obsolescence risks
- Lead material- or impurity-related deviations root cause analyses and CAPAs.
- Trend process related impurities and selected material quality attributes; build predictive monitoring and alert limits for APIs and critical process materials.
- New product introductions and tech transfer: Assess site start-up readiness and timelines with respect to new process materials.
- Maintain procedures templates and forms
- Ensure standardization and efficiency across processes
- Collect feedback from program managers and subject matter experts to improve and simplify the processes
- Support internal/external audits and regulatory authority inspections; present risk assessments process impurities control strategies and evidence of effectiveness.
Cross-functional leadership:
- Collaborate and find opportunities to harmonize approaches create synergies and contribute to the development of Raw Materials Center of Excellence.
Your profile
Minimum qualifications skills and competencies
- MS in Chemical Engineering Chemistry Pharmaceutical Sciences or related field.
- 5 years (Scientist/Engineer) in MSAT Process Development Quality or related GMP manufacturing role in pharma/biotech.
- Hands-on experience performing and defending drug product risk assessments (e.g. ICH Q3C and Q3D assessments)
- Demonstrated knowledge of raw material/process material qualification and specification setting in a GMP environment.
- Strong knowledge of cGMPs and ICH guidelines (Q3 series Q7 Q8 Q9 Q10; for biologics also Q11) BPOG USP <665>/<1663>/<1664>) and materials of construction.
- Experience with supplier technical management and dual-source/alternate material qualification.
- Clear technical writing and presentation skills; ability to communicate complex rationales to regulators and auditors.
- Bilingual French English
- On-site or hybrid; ability to spend time in development and manufacturing areas as needed with PPE and cleanroom gowning as required.
- Occasional travel to suppliers/CMOs and/or supporting on-site audits (up to 10%).
Contact
If you are ready to actively contribute and join a dynamic sector please submit your CV via our online form along with a cover letter highlighting your relevant experience and explaining why you are interested in this position.
In case of questions please reach out to
In case of questions please reach out to
About us
Adragos Pharma is a reliable Contract Development and Manufacturing Organization (CDMO) headquartered in Munich Germany. We provide comprehensive development and manufacturing services for drug products including sterile and non-sterile liquids solids and semi-solids. Our expertise also covers biologicals orphan drugs clinical trials fill-and-finish and lyophilization offering end-to-end solutions from product development to commercial supply.
With production sites in Germany France Greece Norway Japan and Switzerland we ensure high-quality manufacturing across all stages of the drug development process.
Founded in 2020 Adragos Pharma has rapidly grown through an ambitious buy & build strategy supported by FSN Capital. With a team of over 900 professionals we are expanding our operations across Europe North America and Japan to become a global leader in the CDMO sector.
As a key player in the pharmaceutical industry CDMOs like Adragos produce 25% of all drugs globally ensuring access to essential medications. With increasing healthcare demands we continue to innovate and set new standards in drug manufacturing.
You want to be part of our dynamic growth Then apply now!
With production sites in Germany France Greece Norway Japan and Switzerland we ensure high-quality manufacturing across all stages of the drug development process.
Founded in 2020 Adragos Pharma has rapidly grown through an ambitious buy & build strategy supported by FSN Capital. With a team of over 900 professionals we are expanding our operations across Europe North America and Japan to become a global leader in the CDMO sector.
As a key player in the pharmaceutical industry CDMOs like Adragos produce 25% of all drugs globally ensuring access to essential medications. With increasing healthcare demands we continue to innovate and set new standards in drug manufacturing.
You want to be part of our dynamic growth Then apply now!
Required Experience:
Senior IC
Key Skills
About Company
Adragos Pharma is a reliable Contract Development and Manufacturing Organization (CDMO) headquartered in Munich, Germany. We provide comprehensive development and manufacturing services for drug products, including sterile and non-sterile liquids, solids, and semi-solids. Our expertis ... View more
