Scientist / Senior Associate Scientist
Our client: Pharmaceutical
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Position: Scientist / Senior Associate Scientist
Location: Navi Mumbai (Turbhe)
Function: Analytical Research and Development(ARD)
Department: Pharmaceutical Sciences
Reporting Manager: Group Leader, Mumbai Campus
Qualifications
PhD in Analytical / Pharmaceutical Chemistry with 1 - 2 years of analytical research experience in Pharmaceutical R&D or M Pharm / M Sc in Analytical / Pharmaceutical Chemistry with 3-5 years of analytical research experience in Pharmaceutical R&D
Essential skills / competencies:
- Good understanding and knowledge of applications of various modern analytical tools and technologies including modern techniques for separation science (e.g., HPLC, GC, NMR, MS, SFC etc)
- Practical experience of developing and validating analytical methods for APIs and various dosage forms such as solids, liquids (oral, topical and parenteral) including work around stability, characterization / isolation of impurities and with a track record of analytical problem solving
- Knowledge and interpretation skills of drug degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products
- Good understanding of quality requirements in analytical support for clinical supplies and methods transfers
- Basic knowledge on Design of Experimentation (DOEs), optimization techniques, chemistry and formulation processes
- Excellent documentation skills for recording research work and ability to summarize results and data in concise memos, development reports, summaries etc; experience of supporting regulatory documents (e.g., validation reports, specifications, stability reports, development summaries, CMC technical sections) for filing to regulatory agencies
- Good communication and presentation skills
Responsibilities
- The incumbent will be responsible for supporting analytical research and development activities (methods development, validations, transfers, documentation, stability etc) for API and formulation projects within the sphere of NCEs, LCM and generics.
- The person hired into this position will work in close collaboration with other functional line colleagues (chemistry, formulation, API scale up etc) to best support product and process development in line with project plan.
- Candidate will be responsible for supporting multiple projects and the interfacing with various customers and partner groups across the organization such as global development team, regulatory, quality, manufacturing and clinical organizations as well as coordinate the analytical activities outsourced to vendors.
- The candidate will be responsible for authoring various documentations such as specifications, test procedures, method validation plans, protocols, development reports, stability data, SOPs, CMC technical sections for regulatory submission etc.
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Interested candidates are requested to please share their resumes, please mention your total experience in this field, your current ctc [fixed, variable, take home], your expectation, and your notice period.
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