JOB DESCRIPTION
Designation: Research Scientist (7-I)
Job Location: Bangalore
Department: BBRC PD ARD GMP
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. Syngenes 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 4240- a 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 Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT) and Syngene BMS Laboratory (SBL) stability programs
Key Responsibilities:
- Routine testing of stability samples using chromatographic dissolution and wet analytical techniques under a GMP environment following all cGMP practices
- Performing instrument calibration method validation and method transfers
- Interpretation of stability data and results trending
- Investigation of OOS/OOT and other laboratory events
- Preparing the Standard Operating Procedure
- Preparing stability summary reports and review of final documents
- Compliance & implementation of quality systems
- Follow environment health and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Responsible for the activities assignedwithin the team
- Deliver analytical results within the established windows and as per applicable guidelines
- Escalation of issues / non-conformity with applicable procedures/policies
- Electronic lab notebook documentation
- Troubleshooting HPLC and dissolution apparatus
- Miscellaneous lab responsibilities
Educational Qualifications: . Chemistry or M. Pharm
Technical/Functional Skills:
- The candidate should have a good educational and theoretical analytical chemistry background
- Good knowledge of analytical techniques
- The candidate should understand instrument calibration method validation and routine analysis
- Good understanding of documentation as per GxP requirements (electronic notebook)
- The candidate should have good proficiency in MS office tools
- Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
- Must have worked in a cGMP-regulated environment exposure to regulatory inspections like US FDA MHRA etc. is must
Experience: 12-15 years with . or 9-11 years with M. Pharm for 7-I
Behavioral Skills:
- Strong commitment toward work and a high level of dedication enthusiasm and motivation
- Good speaking-listening-writing skills attention to detail proactive self-starter
- Ability to work successfully in a dynamic environment
- Should be able to work in a team and flexible for working in shifts.
- Ability to meet tight deadlines and prioritize workloads.
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 with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
JOB DESCRIPTIONDesignation: Research Scientist (7-I)Job Location: BangaloreDepartment: BBRC PD ARD GMPAbout SyngeneIncorporated in 1993 Syngene International Ltd. is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pha...
JOB DESCRIPTION
Designation: Research Scientist (7-I)
Job Location: Bangalore
Department: BBRC PD ARD GMP
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. Syngenes 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 4240- a 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 Purpose (1-2 Lines): Analytical Research and Development working on Analytical GMP testing (AGT) and Syngene BMS Laboratory (SBL) stability programs
Key Responsibilities:
- Routine testing of stability samples using chromatographic dissolution and wet analytical techniques under a GMP environment following all cGMP practices
- Performing instrument calibration method validation and method transfers
- Interpretation of stability data and results trending
- Investigation of OOS/OOT and other laboratory events
- Preparing the Standard Operating Procedure
- Preparing stability summary reports and review of final documents
- Compliance & implementation of quality systems
- Follow environment health and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Responsible for the activities assignedwithin the team
- Deliver analytical results within the established windows and as per applicable guidelines
- Escalation of issues / non-conformity with applicable procedures/policies
- Electronic lab notebook documentation
- Troubleshooting HPLC and dissolution apparatus
- Miscellaneous lab responsibilities
Educational Qualifications: . Chemistry or M. Pharm
Technical/Functional Skills:
- The candidate should have a good educational and theoretical analytical chemistry background
- Good knowledge of analytical techniques
- The candidate should understand instrument calibration method validation and routine analysis
- Good understanding of documentation as per GxP requirements (electronic notebook)
- The candidate should have good proficiency in MS office tools
- Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
- Must have worked in a cGMP-regulated environment exposure to regulatory inspections like US FDA MHRA etc. is must
Experience: 12-15 years with . or 9-11 years with M. Pharm for 7-I
Behavioral Skills:
- Strong commitment toward work and a high level of dedication enthusiasm and motivation
- Good speaking-listening-writing skills attention to detail proactive self-starter
- Ability to work successfully in a dynamic environment
- Should be able to work in a team and flexible for working in shifts.
- Ability to meet tight deadlines and prioritize workloads.
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 with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
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