- 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.
- Experience: 5 to 10 years
- Education: Minimum MSc, B Pharm, M.
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Associate Scientist - new delhi, India - Johnson and Johnson
Description
Position 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 designeeKey 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/projectswith 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:
Minimum Qualification for the position:
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
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