Major role in development and optimization of analytical methods for raw materials and finished products, as per regulatory requirements. Formulation-analytical work would require knowledge and experience in handling liquid chromatography (HPLC, UPLC and preparative chromatography), gas chromatography (volatile organics, leachable and extractible studies) dissolution techniques, wet chemistry techniques (water analysis, pKa, partition coefficient), mass spectrometry (structural characterization by LCMS) etc. Characterization of physico-chemical properties of molecules and excipients. Experience in interpretation of data from thermal analytical techniques (DSC, TGA, etc.), particle size characterization, X-ray crystallography (polymorphism and amorphous characterizations) etc. Preparation, review and maintenance of documents such as SOPs, protocols, reports and presentations. Directly managing a small team of junior staff to achieve the set objectives and regular feedback to supervisor on the progress of assigned work. Training and mentoring of team members. Guidance, mentoring and oversight of analytical raw data, calculations, results and conclusions. Analytical method transfer to other locations. Any other responsibilities delegated by Supervisor from time to time. Experience in analysis of Peptides/Proteins would be added advantage.
Post: Scientist II
Responsibilities
Hands on experience in developing analytical methods for dosage forms forms like liquids, solids and injectable. Knowledge of drug discovery process and experience in testing of clinical trial batches (Phase I, II and III) supplies would be valuable. In depth knowledge of preformulation studies, material characterization (physical forms) techniques. Ability to work with limited quantities of API to develop robust methods. Excellent communication, presentation skills and scientific/technical writing skills. Demonstrate ability to manage time and resources effectively. Candidate must have a sense of urgency and desire to get things done effectively and efficiently.
Must be able to demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought process. Must be willing to work as a part of team and be able to demonstrate good interpersonal skills. Undertaking multiple projects, tasks and co-ordination within and outside the team. Working with and updating cross-functional and cross-cultural teams across sites. Maintenance of laboratory as per the research specific regulatory requirements and if needed to meet cGMP/cGLP requirements.
Requirements
M.Sc /M.Pharm with specialization in Pharmaceutical Chemistry/ Chemistry/ Analytical Chemistry required. Ph.D. with Pharmaceutical Chemistry/ Analytical Chemistry highly desired. 8-12 Years with M.Sc./ M.Pharm. or 4-6 years with Ph.D. Experience in Analytical R&D of drug product from a reputed pharmaceutical company. Experience with development, validation and technology transfer of analytical methods required to test drug products. Expert in method development using HPLC, UPLC, GC, Dissolution, wet chemical techniques, etc. Hands on lab experience of 6-8 years followed by 2-4 years of supervisory experience. Experience in managing a team of 2-3 scientists.
Location: Hyderabad, India
Job ID: IN3006-3455- R
Area of Interest: Product Development
Job Type: Full-Time
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