Manager
Rubicon Research Limited
The candidate shall be responsible for managing a team of analysts and guiding them in method development, routine analysis and partial method validation to support pharmaceutical formulation development of solid and liquid oral products preferably for US market. Additionally, he/she shall be responsible for co-ordination with cross functional teams and other units, and review documents, manage and guide the team members.
Position / Job Title - Manager
Department - Analytical Department
Reporting To - Assistant General Manager
Location - Thane
Years of Experience -10+ years
Dosage Form - Solid and Liquid Orals
Job Responsibilities / Deliverables Job Function
- Development of stability indicating test methods and other analytical methods as per the dosage form in line with regulatory requirements and smooth transfer to analytical method validation team.
- Evaluation of analytical results and co-ordination with formulation teams.
- Preparation and review various documents like Specs/STPs/protocols/AMDR.
- Provide inputs for finalization of API, excipients, and finished product specifications.
- Providing technical inputs based on literature, personal experience and available project documents.
- Stability Study Management
- Guiding the team for all types of analytical activities such as method development. Partial validation, trouble shooting, etc.
- Execution of technical deliverables as per target timelines
- Review and ensure adequacy of the technical documents like analytical methods, specifications, method development reports, study protocols etc
- Providing inputs for SOP preparation
- Ensuring the data integrity and accuracy of supporting data
- Monitoring to adherence of GLP compliance by team members
- Adherence to quality systems, lab practices to ensure compliance to internal/ external audits
- Support to units for OOS and OOT investigations as and when required.
- Interactions with departments / Teams / Sub functions such as FD, SCM, PMI, QC, DQA, CQA, and IT for requirements of project activities
- Coordination with units’ timely execution of exhibit batches, etc.
Must-Have Qualification and Skills:
- MSc. Chemistry/ M. Pharm Pharmaceutical Analysis
- Knowledge of interpretation of developed methods on HPLC /GC/PSD/IR.
- Current regulatory guidance awareness.
- Experience of managing teams
- The candidate is expected to work in any of the shifts as per requirement.
- The candidate is expected to visit all sites of Rubicon for Method Transfer/ Investigations as per requirement.