Scientist / Senior Scientist (Analytical R&D) (14052022) Navi Mumbai, India
Responsibilities
The incumbent will be responsible for supporting analytical research and development activities (methods development, validations, transfers, documentation, stability, etc.) for API projects within the sphere of NCEs, LCM, and generics. The person hired for this position will work in close collaboration with other functional line colleagues (process chemistry, API scale-up, etc.) to best support API synthesis and process development in line with project plan. Incumbent will be responsible for supporting multiple projects and interfacing with various customers and partner groups across the organization such as the global development team, regulatory, quality, and manufacturing as well as coordinate the analytical activities outsourced to vendors. The candidate would provide analytical support to Chemical R&D & API Pilot Scale-up facility during various stages of API synthetic process development & its scaleup activities. Analytical development experience of formulation projects is an advantage. The candidate will be responsible for authoring/reviewing various documentation such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc. Projection and effective management of resources to ensure timelines, budgets and deliverables are met as per project requirements will also be a part of the role
Qualifications
PhD in Organic/ Analytical / Pharmaceutical Chemistry / Instrumentation with 4+ years or M Pharm / MSc in Organic/ Analytical / Pharmaceutical Chemistry / Instrumentation with 10+ years of experience in analytical R&D.
Essential skills / competencies
• In depth understanding and knowledge of applications of various modern analytical tools and technologies (HPLC, GC, etc.), including modern techniques for structural elucidation (e.g., NMR, IR, MS etc.) and data interpretation.
• The candidate should be well versed with Solid state characterization techniques such as DSC, TGA, DVS, PSD & XRD.
• Experience with a wide range of substrates from API characterization/isolation of impurities and with a strong, proven track record of analytical problem-solving in various types of products.
• Extensive knowledge and interpretation skills of degradation pathways, stress stability designs, and stabilization techniques.
• Good understanding of quality requirements in analytical support for clinical supplies and manufacturing transfer work
• Good understanding of chemistry processes; basic knowledge of Design of Experimentation (DOEs) and optimization techniques
• Analytical R&D experience on formulation projects is preferred but not essential.
•Experience of authoring regulatory documents for filing to regulatory agencies
• Good at interpersonal, leadership, communication, and presentation skills are essential
• Excellent documentation skills for recording research work and ability to summarize results and data in concise memos, development reports, summaries, etc.; experience in supporting regulatory documents (e.g., validation reports, specifications, stability reports, development summaries, CMC technical sections) for filing to regulatory agencies
Other attributes desirable
• Exhibits a thorough understanding of own scientific/technical area. Stays current with new developments and trends in that area and their application to development projects
•Uses knowledge and experience to design, conduct and interpret data from experiments. Plans work independently based on specific objectives. Prioritizes tasks; keeps management/team informed of progress and adjusts work accordingly. Displays knowledge of project goals.
• Demonstrates the ability to identify and recommend solutions for problems that arise in the course of experimentation. Identifies and utilizes the most reliable resources to get at the root of a problem.
- Understands safety. Considers safety an integral part of planning for and performance of work function.
- Communicates technical information efficiently and accurately. Practices active listening skills to understand information being communicated by others. Can deliver articulate presentations in a team environment. Writes clearly and concisely. Maintains laboratory notebook meeting corporate standards.
- Modifies techniques and work processes to improve the way work is done, introducing imaginative approaches and championing new technologies to improve group/team performance.
- Recognizes the importance of relationships within the work group. Builds a sense of partnership with others in the work group to achieve results. Builds and maintains a strong network with people from other departments to enhance collaboration on assignments.
- Experience of working as part of international teams, working with contract research organizations or Marketing / Commercial colleagues and familiarity of the Animal Health industry would be good