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.
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
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
- With general guidance from supervisor, 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.
- 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