AddressPosition Title: Associate Scientist - Mumbai (Mulund)
The objective of this position is to deliver analytical services to various global R&D sites. The position demands an analyst role to manage the analytical activities with a compliance focus under the supervision of J&J analytical team leader or designee.
Key responsibilities:
o To deliver the project activities within timelines considering compliance to quality and safety.
o Responsible for executing the analysis regarding the physicochemical and instrumental analysis.
o To execute experiments/projects with a high degree of precision and attention to detail. Analyze data, evaluate results, form conclusions, and implement improvements.
o Demonstrate ingenuity, creativity, and resourcefulness in design of studies and experiments.
o Ensure activities are consistent with project critical path and respond appropriately to changing priorities.
o Responsible for continuous improvements within area of responsibilities.
o Flexibility to work in any project/ team as per the business requirement.
o To participate and execute technology transfer and development under laboratory.
o To execute computer system validation (CSV) activities as per J&J procedures and current guidelines.
o To initiate and coordinate for Quality Issues (QI) and Change Controls .
o To implement corrective and preventive actions resulting from internal audit/ regulatory audit.
o To generate and maintain raw data/ records as per applicable procedures.
o Preparation of Stability Protocols, Reports, SOP, Work Instructions, and other quality documents as required.
o Responsible for supporting Internal/External audits.
o Collect and share the data with the external contract laboratories for the projects handled within group.
o Follow cGMP and implement current pharmaceutical regulations and compendial requirement in the laboratory.
o Cooperate efficiently with the external and internal partners.
o Practice and implement Leadership imperatives for customer satisfaction, innovation, collaboration, organization.
Functional competencies:
- Working knowledge of UPLC/ HPLC, GC, XRD, Dissolution, Coulometer, PSD, NIR, LIMS & ELN platforms.
- Technical expertise related to chemistry, analytical techniques, stability study assessment and research technologies.
- Ability to plan and execute analytical assignments.
- Knowledge of analytical techniques and ability to identify gaps, root causes of issues and think out of the box to develop a solution.
- Adequate knowledge of cGMP, quality systems, data integrity, SOPs, and global regulations as appropriate
- Technical skills related to interpretation of analytical data and accurate documentation of laboratory investigations and non-conformances.
Qualifications
Minimum Qualification for the position:
- Experience: 5 to 10 years
- Education: Minimum MSc, B Pharm, M. Pharm
- Other Skills: Good computer proficiency (MS office)
- Critical Personality Attributes:
o Good verbal and written communication skills.
o Good computer proficiency (MS office)
o Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
o Proven ability to learn new skills quickly and adapt to new processes smoothly.
o Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines
