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Title: Fill & Finish Lead
Location: Schaffhausen, Switzerland
Rate: Open
Openings: 1 Lead
Contract/Perm: Contract (18-Months)
Join the team and be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.
探花合集 is seeking a Fill & Finish Lead to join our client's team in Schaffhausen, Switzerland. This role focuses on leading fill and finish projects within the pharmaceutical industry, particularly in analgesics and anaesthetics.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Key responsibilities
- Lead Fill Finish (and Device Assembly) projects (Focus on fill & finish)
- Representation of Fill Finish Pilot Plant interfacing with the Drug Product Development group, the Drug
- Delivery Systems group, the supply management team ensuring timely clinical supplies.
- Ensure that manufacturing relevant information and technical capabilities are in place for the operations team to flawlessly produce the DP/DA according to GxP, EHS and business requirements
- Ensure timely plant readiness and support the operations team in the execution of the experimental/clinical activities
- Ensure timely delivery of clinical material from to Pack&Label sites (internal and/or external)
- Manage the overall relationship with internal/external stakeholders and act as the single point of contact between the organization and pilot plant facility
- Provide pilot plant input & requirements as required
- Source raw materials and components when required
- Ensure that manufacturing processes are consistent with agreed platforms and are scalable and transferable to commercial operations
- Ensure and/or support planning, execution and documentation (protocols, reports, memo)
- Support investigations, CAPAs, change controls according to assigned responsibilities, and performs critical raw data review for key documents
- Forecasts and monitor actual spending vs budget
- Maintain compliance with all company policies and procedures
Requirements
- A degree in Pharmaceutical/Biochemical/Chemical or relevant Sciences or comparable experience in pharmaceuticals or in a related field with demonstrated ability (3+ years) OR a PhD with proven experience (1+ years)
- Demonstrated proficiency and experience in biologics drug product development and/or device assembly within the biopharmaceutical industry is helpful
- Demonstrated proficiency and experience of biopharmaceutical process design is helpful
- Solid understanding and experience of technology transfer operations is preferred
- Solid understanding and experience in fill/finish operations and/or device assembly is preferred
- Proven track record of creativity and problem solving
- Ability to collaborate with cross-functional teams is a must
- Excellent oral and written language skills in English (German is a plus)
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
探花合集 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 探花合集 is acting as an Employment Agency in relation to this vacancy.
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