MSAT Product Scientific Expert
MSAT Product Scientific Expert – Microbiology/Pharma/GMP/CMO/Statistical tools and methodologies/
Project: For our customer a big pharmaceutical company in Basel we are looking for MSAT (Manufacturing Science and Technology) Product Scientific Expert (m/f/d).
Background: The Pharma Technical Operations (PT) Global MSAT & Engineering (PTT) group takes bold steps to modernize technical operations so we can deliver medicines for patients more quickly, efficiently and reliably. In partnership with PT colleagues, we shape and accelerate technology innovation and product lifecycle management for tomorrow, while standardizing and driving operational excellence in PT today. The PTT – global Manufacturing Science and Technology (gMSAT) department focuses on technical support for commercial products in our internal and external drug substance and drug product network, implementation of new technologies, network standardization and distribution technologies. The PTT MSAT Scientific Experts provide technical leadership and implements solutions across PT manufacturing and distribution networks. Responsibilities are to drive technical product lifecycle improvements and deliver technical solutions for robust, efficient, manufacturable, sustainable, and compliant manufacturing process across internal and external PT manufacturing network.
The perfect candidate. We are looking for an experienced candidate who is available asap and can jump right into the daily business. The Microbiology background should be paired with GMP and CMO knowledge and the mentioned soft skills. Fluent in English is a must.
Tasks & Responsibilities:
* Assess performance of manufacturing processes for products in scope and the portfolio and implement improvements related to robustness, speed and efficiency together with safety and sustainability elements. Resolve product issues, risks, and opportunities. Ensure maintenance of the process validated state at CMOs
* Authors and reviews technical documents (such as: manufacturing documents, qualification documents, etc.) and regulatory submissions for products in scope and the portfolio. Contributes to health authority information requests as well as internal and external quality audits
* Contribute to and drive process and technology initiatives that deliver improvement to product robustness (i.e. zero defects, manufacturability, supply chain resilience, cost of goods, sustainability) and forward-looking capabilities (incl. novel / new technologies) throughout the product lifecycle. This may include transitions of pipeline molecules from development to commercial through product/site launch risk mitigations.
* Drive robustness improvements of manufacturing and/or distribution processes in support of technical transfers and/or integration of new technologies, also translating technical elements of product strategies into technical objectives and outcomes, enabling transparency and PTx prioritization
* Contribute and/or lead matrix cross-PT network teams consist of engineers and scientists to deliver aligned network technical solutions for product lifecycle improvements, materials knowledge & sciences, process data analytics, knowledge management, and/or new technology implementation
* Deliver on projects or initiatives relevant to technical product lifecycle, technical standardization, and/or new technology per focus areas
* Owns and manages process and product technical knowledge for the assigned product families and/or site (ie internal and external manufacturing network)
Must Haves:
* Min. Bsc/Msc degree in Biotechnology, pharmaceutical or process/chemical engineering
* Min. 5 years of experience as Scientific Expert in the field of large molecules / sterile DRUG PRODUCT manufacturing or development
* Strong Knowledge in interacting and managing an external CMO, especially transferring the needs
* Hands-on knowledge of GMP, microbiology and drug product requirements
* Experience and capability in detail-oriented documentation
* Experience in Statistical tools and methodologies (e.g. Minitab) and understanding of data and analytics as well as capability to present them to different audiences
* Fluency in English, German is advantage
* Ability to communicate and collaborate with different stakeholders
* Self-driven and project management skills
* You anticipate complex problems and contribute to problem solving by identifying key influencing factors and pointing out possible solutions. You communicate clearly and effectively to explain complex concepts and convince high-ranking executives of alternative points of view
Reference Nr.: 923524OK
Role: MSAT Product Scientific Expert
Industry: Pharma
Workplace: Basel/Kaiseraugst
Workload: 80%-100%
Start: asap (latest Start Date: 1.9.2024)
Duration: 12 months
Deadline: 11.07.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com. Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.
About us: ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering. We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.
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