Senior Associate Scientist/ Scientist (28082020) Navi Mumbai, India
Senior Associate Scientist/ Scientist (Based on the experience and qualifications)
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/reviewing various documentations such as specifications, test procedures, method validation plans, protocols, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.
M Pharm / M Sc in Analytical / Pharmaceutical Chemistry with 4+ years of analytical research experience in Pharmaceutical R&D OR PhD in Analytical / Pharmaceutical Chemistry with 2+ years of analytical research experience in Pharmaceutical R&D
Essential skills / competencies
- Good understanding, knowledge and experience with various modern analytical tools and technologies including modern techniques for separation science (e.g., HPLC, GC, NMR, MS, Dissolution, etc).
- Practical analytical experience handling APIs / dosage forms including solids and liquids for oral, topical and parenteral administration; including work around stability, characterization / isolation of impurities and with a track record of analytical problem solving for various types of products.
- Knowledge and interpretation skills of drug degradation pathways, stress stability designs, stabilization techniques and biopharmaceutical aspects of drug products.
- Fair understanding of quality requirements in analytical support for clinical supplies and manufacturing transfer work.
- Good understanding of chemistry and formulation processes; basic knowledge on Design of Experimentation (DOEs) and optimization techniques.
- Good at interpersonal, leadership, communication and presentation skills are essential.
- Good 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
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 rootofaproblem.
- Experience of authoring regulatory documents for filing to regulatory agencies.
- 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.