Senior Lead Scientist

JOB DESCRIPTION

Designation: Sr. Lead Scientist – MV&SI

Job role – Reviewer / Section Head

Job Location: Bangalore

Department: Analytical Development

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development, and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries worldwide. Syngene's clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market, and lower the cost of innovation.

Job Description: Planning and allocation of Routine and non-routine activities for the entire team member. Investigation of QMS Elements and Report Generation, Approval and co-ordination with QA and Maintaining a QMS/TAT/TPA matrix.

Key Responsibilities: 

1. Planning and allocation of Routine and non routine activities for the entire team member.
2. Interaction with production, ADL, R&D,QA and other department for QC related functions.
3. Interaction with client and Project team for the smooth functioning of project related activities.
4. To review the In-process, cleaning, intermediate and finished product specification.
5. Initiate the change control and taking approval from analytical QA.
6. Planning and allocation of Documentation preparation.
7. Review of routine/non-routine validation reports.
8. Review of method verification and method validation protocol.
9. Review of standard qualification protocol, forced degradation protocol and method transfer protocol.
10. Ensuring, verifying and reviewing the instrument usage log periodically and accordingly checking the lables as per SOP.
11. To maintain the sampling packing area
12. Investigate and close for planned and unplanned deviations.
13. Review of Certificate of analysis.
14. Approval of specification of Non-technical batches.
15. Responsible for Ensuring that the Good Laboratories Practices are followed while working in QC Laboratory.
16. Responsible for Ensuring the Use of required safety apparels while sampling, analysis and working in Laboratory.
17. Responsible for taking any other job allocated by Head of the Department.

To ensure safety compliance as per Syngene policy and EHSS requirements.

Educational Qualification:  M Sc / M Pharma (Analytical/General chemistry)

Technical/Functional Skills:

1. Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc...
2. Being well-versed in the Chromeleon data management application and LIMS will be advantageous.

Experience: 6-10 years

Behavioural Skills:

• Should be an adaptive learner.
• Should demonstrate effective Communication skills.
• Organization and ability to balance work and Life.
• Should possess good Time Management abilities.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.