Senior Development Scientist
Department: Research and Development Science
Supervisor: Senior Scientist/ Staff Scientist/ Manager, Development Science
Summary of responsibilities: The ideal candidate will execute bio-conjugation & purification chemistry design and development efforts and transfer the technology to deliver consistent and cost effective production processes to GMP manufacturing. The incumbent leads and performs experiments; reviews test results for experimental error and determines if repeats are required; participates in planning studies for the development, evolution and optimization of product design; maintains well organized laboratory notebooks in compliance with relevant procedures; and supports post-launch activities to resolve performance and/or quality issues.
Boundary Conditions/Authority Levels: Receives no instruction on routine work
Essential Duties and Responsibilities: include the following. Other duties may be assigned.
- Leads the analysis, design and development of reagents and applications, specifically novel antibody conjugation and characterization methods for use in Flow Cytometric applications.
- Ensures design inputs are aligned with the user requirements and the finalized design matches the input requirements
- Primary responsibility to lead the lab work as per project schedule (Bio conjugation, Protein purification, Formulation, Protein estimation by Biochemical assays) & ensures on time completion
- Creates study plans in alignment with requirements of applicable standards and regulatory requirements and ensures the studies are conducted in agreement with approved plans
- Reports status of experiments to supervisor, trains and supports direct reports as needed
- Applies analytical skills and independent judgment to develop innovative, practical and consistent solutions to a wide range of complex problems.
- Ensures strict adherence to the quality system elements and technical standards as applicable for reagent development
- Creates reports to summarize various development activities and supports in creation of work instructions to transfer the design to manufacturing
- Ensures strict adherence to good laboratory and good documentation practices throughout the design and development cycle
- Lead efforts in technology transfer related to conjugation/purification/analysis from discovery to process development
- Flexible to take up new challenges & Performs other related duties as required.
Education and/or Experience:
Core expertise in protein biochemistry, Bio-conjugation chemistry, exposure to Tandem chemistry, , Hands on experience on protein purification techniques. Exposure to Flow cytometry or other assay development techniques would be an added advantage. Hands on Experience with various Chromatography techniques like Preparative or Analytical chromatography (Affinity, IEC, MMC, SEC) and advanced laboratory measurement systems are desired (AKTA, HPLC, Spectrophotometer, Protein estimation techniques, FRET analysis, CE, FT-IR)
Advanced degree in Biochemistry, Engineering, Protein chemistry, Life sciences or related discipline, for example bachelor’s degree in field with 8+ years’ experience OR Master’s degree in field with 6+ years’ experience OR Doctoral degree in field with 4+ years’ experience.