Analytical Development Scientist

Analytical Development Scientist

Role & responsibilities

Execution of experiments for analytical method development/ qualification/ transfer, in-process/ stability sample testing, biosimilarity analysis and for evaluation of new high throughput formats of testing using chromatography (HPLC/UPLC), electrophoresis / capillary electrophoresis, UV spectrophotometer, and other high-end analytical tools.

Sequential and logical planning of experiments.

Record the experiment details (procedure, controls, analyses, and observation of the experiments) accurately and completely following good documentation practices in electronic laboratory notebook.

Compilation, and interpretation of data for reports. Perform data trending on a regular basis.

Communication of data to cross-functional teams and participate in internal group meetings.

Prepare documents such as method development reports, protocols, instrument operation procedures, author change controls and deviations.

Perform literature survey of assays, support in experimental design based on historical data and troubleshooting of experiments

Maintain equipment and instruments in coordination with instrumentation team and support installation of new equipment and prepare Equipment/Instrument operating procedures

Regularly track inventory of consumables/ critical reagents and making sure they are ordered and follow-up of the ordered material and support in laboratory maintenance.

Participate in QMS related activities.

Education:

Degree in life sciences such as biology, biochemistry, biotechnology, analytical chemistry or closely related field

M.Sc./M. Tech with 5-7 years of research experience

Required Experience:

Relevant experience in renowned biopharmaceutical companies

Adequate experience in chromatographic techniques such as IEC, RP, SEC, HILIC etc for protein therapeutics. Experience in excipient analysis using ELSD, CAD and MS platforms preferred.

Experience in handling instruments like HPLC, CE, UV spectrophotometer, SoloVPE, Octet, Maurice, Microplate Reader is desired.

Ability to contribute towards experimental design, troubleshooting in a team environment.

Experience in analysing data using relevant instrument software and familiarity with statistical tools is desired.

Knowledge of ICH, WHO, USP guidelines for development, qualification, transfer, validation is essential and experience with electronic laboratory notebook system is desired.

Ability to communicate ideas, concepts, challenges and be a team player.

Familiarity with Empower Method Validation Manager is desired.