Bioassay Expert in Research and Development (m/w/d)
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