MS DSP Senior Laboratory Specialist
vor 21 Stunden
Job Title: MS Senior Laboratory Specialist DSP Position
Location: CHE - Neuchâtel
Primary DutiesThe Manufacturing Science (MSci) department is the owner of the process; hence this team of Subject Matter Experts (SMEs) is a key player for all complex issues or projects involving the product.
MSci Senior Laboratory Specialist DSP is the SME for the lab scale product/process at Neuchâtel and covers the planning and execution of "scale down" purification activities, supports the DSP laboratory team regarding protocol execution, troubleshooting, and process robustness improvement projects at laboratory scale.
Key Responsibilities- Perform the following tasks as support to another team member, as a coach, or as project lead:
- Planning and execution of "scale down" purification activities
- Complex investigations and product impact assessment in protocols/studies deviations related to product
- Process/equipment improvement projects including technology transfer
- Small scale/scale down product validation activities
- Writing of reports/review of documents and reports
- Perform relevant escalation/communication of critical issues
- Ensure efficient lab scale project performances through Quality by Design (QbD) and Continuous Process Improvement approaches
- Train and coach new lab members
- Manage documentation associated with laboratory activities
- Control the laboratory equipment under responsibility, ensure their maintenance, and solve operating problems independently
- Manage the stocks and inventory of consumables necessary for laboratory activities and participate in laboratory logistic activities
- Master's in biochemistry, biotechnology, or relevant scientific discipline
- Minimum 5 years of experience in the pharmaceutical industry, ideally in process development
- Good knowledge of a GMP environment and quality requirements
- Extensive experience and theoretical knowledge of proteins and chromatography/UF processes
- Strong communication skills and team spirit with the ability to effectively communicate at multiple levels in the organization
- Fluent in French and English (C1/2)
- Good knowledge of Unicorn software
- Good knowledge of the Windows environment and Microsoft Office Suite
- Knowledge of Minitab software is a plus
- Basic LIMS and Trackwise knowledge
- Strong knowledge of recombinant protein purification and scale down
- Hands-on experience in chromatography/UF processes
- Good knowledge of recombinant protein analytical methods (Activity, ELISA, SDS, etc.)
- Knowledge in cell culture and statistics is a plus
- Basic knowledge of quality systems (Trackwise, LIMS)
- Experience in installation and qualification of lab equipment
- Strong organizational and follow-up skills, as well as attention to detail
- Able to deal with statistics and scientific data
- Strong analytical and problem-solving skills regarding purification issues, scale up/scale down issues, and analytical issues
- Scale down model design and qualification to be representative of manufacturing scale
- Ability to make data-driven decisions promptly and appropriately in complex situations
- Ability to manage multiple priorities
- Manufacturing science teams in Neuchâtel, Singapore, and Thousand Oaks, and occasionally with other Manufacturing science teams
- Quality control teams in Neuchâtel, Vienna, and Orth
- Locally with all departments: Automation, Metrology, ISS, Manufacturing, QA, Engineering
- GMSCi Pharm Science in Vienna
Hands-on experience working in a laboratory environment with a strong EHS and GxP mindset.
LocationsCHE - Neuchâtel
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
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