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Bioassay Expert in Research and Development (m/w/d) (DE)
[13330]
R&D, Bioassay, Bioanalytical Science
Job title: Senior Scientist Bioassay R&D (f/m/d) Industry: Biotech Skills: R&D, Bioassay, Bioanalytical Science Start of project: 01.09.2023 Duration of the project : 9 months Location: Bern, Switzerland Tasks: ·Responsible for providing critical cell-based assay expertise to complement the existing in-house product characterization team and delivering on cell-based functional assays as per project requirements using appropriate state of the art technology platforms. ·Responsible for defining phase-appropriate bioassay strategies for product development. In addition, enabling characterization of products and link to the targeted mechanism of action (MoA) using design of experiment (DOE) and analytical QbD ·Responsible for executing, developing, optimizing and qualifying functional assays (cellular and molecular-based assays as appropriate) to mimic in vivo product efficacy and/or safety ·Actively contribute to new methodologies and next generation technologies by keeping abreast of next generation platforms, identifying, evaluating, and implementing appropriate innovative approaches with a focus on potency assays • Responsible for supervising and coaching junior scientist in performing and developing cell-based methods ·Act as BAS Subject Matter Expert (SME) relating to cellular and biological-related assays, provide scientific input to multiple projects and technical teams ·As a functional assay SME, ensure successful transfer of assays and knowledge to contract labs/CROs including troubleshooting issues relating to challenges in setting up the assays at the CRO labs ·Author lab procedures, protocols, reports and SOPs for internal and/or external partners. Present at internal and external seminars and conferences. ·Collaborate with Group members and cross-functional teams to support product characterization, process development, and other studies. Ensure close collaboration with other local and global functions across the R & D network. Qualifications: ·Ph.D. in Cell Biology, Biochemistry, Biological Sciences or related fields with +3 years of biopharmaceutical industry experience in the field of cellular and molecular assay development for product development ·Excellent understanding of biological and cellular mechanism of actions (MoA) of different biomolecules (antibodies, therapeutic proteins) for the development of fit-for purpose assay to determine product safety and efficacy ·Proven track of record in applying the principle of analytical QbD for qualifying cellular and molecular-based assays to support product development programs ·Hands-on experience in a wide range of biological and immunological techniques (eg. FACS, chemiluminescence, fluorescence, FRET, LANCE, FP) as well as affinity-based techniques (SPR, BLI) ·A solid understanding of current statistical approaches and data analysis packages to evaluating potency results (e.g. GraphPad Prism, SoftMax Pro, JMP, Matlab, PLA). ·Hands-on experience in good cell culture practices such as excellent aseptic techniques, isolating, culturing and troubleshooting as required. Experience working with BSL2 level biological agents. ·Good understanding of scientific process, including hypothesis development and experimental design (DoE) with an ability to capture, design and record complex scientific data accurately and reliably ·Proficient English verbal and written communication skills with ability to work independently as well as in a team environment
Skills: R&D, Bioassay, Bioanalytical Science
- Responsible for providing critical cell-based assay expertise to complement the existing in-house product characterization team and delivering on cell-based functional assays as per project requirements using appropriate state of the art technology platforms.
- Responsible for defining phase-appropriate bioassay strategies for product development. In addition, enabling characterization of products and link to the targeted mechanism of action (MoA) using design of experiment (DOE) and analytical QbD
- Responsible for executing, developing, optimizing and qualifying functional assays (cellular and molecular-based assays as appropriate) to mimic in vivo product efficacy and/or safety
- Actively contribute to new methodologies and next generation technologies by keeping abreast of next generation platforms, identifying, evaluating, and implementing appropriate innovative approaches with a focus on potency assays • Responsible for supervising and coaching junior scientist in performing and developing cell-based methods
- Act as BAS Subject Matter Expert (SME) relating to cellular and biological-related assays, provide scientific input to multiple projects and technical teams
- As a functional assay SME, ensure successful transfer of assays and knowledge to contract labs/CROs including troubleshooting issues relating to challenges in setting up the assays at the CRO labs
- Author lab procedures, protocols, reports and SOPs for internal and/or external partners. Present at internal and external seminars and conferences.
- Collaborate with Group members and cross-functional teams to support product characterization, process development, and other studies. Ensure close collaboration with other local and global functions across the R & D network.
- Ph.D. in Cell Biology, Biochemistry, Biological Sciences or related fields with +3 years of biopharmaceutical industry experience in the field of cellular and molecular assay development for product development
- Excellent understanding of biological and cellular mechanism of actions (MoA) of different biomolecules (antibodies, therapeutic proteins) for the development of fit-for purpose assay to determine product safety and efficacy
- Proven track of record in applying the principle of analytical QbD for qualifying cellular and molecular-based assays to support product development programs
- Hands-on experience in a wide range of biological and immunological techniques (eg. FACS, chemiluminescence, fluorescence, FRET, LANCE, FP) as well as affinity-based techniques (SPR, BLI)
- A solid understanding of current statistical approaches and data analysis packages to evaluating potency results (e.g. GraphPad Prism, SoftMax Pro, JMP, Matlab, PLA).
- Hands-on experience in good cell culture practices such as excellent aseptic techniques, isolating, culturing and troubleshooting as required. Experience working with BSL2 level biological agents.
- Good understanding of scientific process, including hypothesis development and experimental design (DoE) with an ability to capture, design and record complex scientific data accurately and reliably
- Proficient English verbal and written communication skills with ability to work independently as well as in a team environment
Lars Uhl