Scientist, Data Scientist, Clinical Research
Behavioral Health Market Context
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Qualifications
- •bachelor of science in analytical chemistry/pharmaceutics with equivalent industry experience
- •3 or more years of applicable industry experience in support of pharmaceutical product development
- •expertise in instrumentation techniques: hplc, gc, ftir, uv, kf, and other wet chemistry testing
- •experience with gmp and ich regulations
- •requires excellent written and verbal communication
- •candidate must be comfortable in a fast-paced work environment
- •mathematical and reasoning ability
- •ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
- •ability to work effectively under pressure to meet deadlines
- •individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds
- •maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site sops
- •ability to learn and retain technical information
- •proactively address work issues at both an individual level and a team level
- •develop and execute complex procedures or methods with high quality
- •becoming familiar with drug development milestones and their context
- •recognizes and elevates changes in project scope or execution for review…
- •13 more items(s)
Responsibilities
- •routine analysis of finishing products & raw material
- •Testing stabilty samplesunder different ich conditions
- •Performing assays, dissolution, hardness tests, water content, contecnt/blend uniformity
- •Analytical testing of excipients & apis using wet chemistry as per compendial monographs
- •performing tests and reporting data according to approved procedures
- •following internal methods, sops, procedures, and monographs for testing
- •conducting data review, data trending, and laboratory investigations as assigned
- •assisting other scientists to ensure timely project completion and supporting other lab personnel as needed
- •adhering to regulatory guidelines, sops, cgmps, and laboratory procedures
- •perform finish product testing (stability, development), qc release and data review
- •perform, assay, related substances, kf, dissolution, disintegration, hardness
- •work on lab instruments (hplc/gc/uplc, kf, dissolution, hardness, disintegration)
- •perform test and report data as per theapproved procedures
- •analyst will follow the internal methods, sops, procedures, monographs to perform the testing
- •work on dea controlled substance
- •conduct laboratory investigation using the trackwise system following sops and procedures
- •perform opex activities, data trending, sops revisions, as assigned.the scientist reports to the quality control & analytical product development, manager/senior scientist/principal scientist
- •The scientist will be performing routine analysis of finish products using laboratory techniques and instrumentation such as hplc, dissolution, karl fisher, ph meter
- •Analyst will perform assay, content uniformity, blend uniformity, moisture testing, related substances, dissolution on finish product
- •Analyst will test in process and fp samples and test stability samples at different ich conditions.our somerset location is the corporate headquarters for pharma solutions
- •under the supervision of other scientists, carry out activities in support of the manufacturing of pharmaceutical products
- •These activities include in-process testing, finished product testing, sample analysis, and physical evaluation of products
- •conduct experiments which includes scope from r&d to clinical and commercial release
- •perform assay/related substances, karl fisher, dissolution, hardness, disintegration etc
- •instrumentation techniques: hplc,gc, uplc, dissolution, uv, kf
- •assist other scientists, as necessary for timely project completion and support other lab personnel as required
- •follow regulatory guidelines, sops, cgmps and laboratory procedures
- •all other duties as assigned
- •25 more items(s)