Position: Scientist

Function: Analytical Research and Development (ARD)

Division / Department: VMRD, Pharmaceutical Sciences, Navi Mumbai 

Reporting Manager:  Group Leader, Navi Mumbai

Responsibilities

The incumbent will be responsible to support analytical research and development activities for NCE (new chemical entity), LCM (life cycle management) and NEB (new established brand) projects. 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, reports, stability data, SOPs, CMC technical sections for regulatory submission etc.

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, knowledge and experience with various modern analytical tools and technologies including modern techniques for separation science (e.g., HPLC, GC, NMR, MS, SFC etc)
• Practical analytical experience handling APIs and various dosage forms including solids and liquids for oral, topical and parenteral administration; including work around stability, characterization / isolation of impurities and with a strong, proven 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
• Good 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
• Experience of authoring regulatory documents for filing to regulatory agencies
• Exhibits a thorough understanding of own scientific/technical Stays current with new developments and trends in that area and their application to development projects. Understands and applies in-house technologies (automation, DOE, etc.).

 Other Desiarable attributes:

• With general guidance from supervisor, uses knowledge and experience to design, conduct and interpret data from 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 Identifies and utilizes the most reliable resources to get at the rootofaproblem.
• Understands Considers safety an integral part of planning for and performance of work function.
• Communicates technical information efficiently and 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
• Recognizes the importance of relationships within the work 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