Title: Senior Executive- QC Bioanalytical
JOB DESCRIPTION
Designation: Senior Executive - QC, Small Molecule Bioanalytical Research Laboratory
Job Location: Bangalore, India
Reporting to: Head / Group Leader of Small Molecule Bioanalytical Laboratory
Job Grade: Level 9-II
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
The Role
The Executive - QC for the Small Molecule Bioanalytical Laboratory is a technical role responsible for reviewing data for BA/BE studies in the laboratory. Job responsibilities include checking method development, validation and sample analysis data.
This role requires an individual with a robust background in pharmaceutics, or other related life sciences, coupled with extensive experience in the bioanalytical field, particularly within small molecule bioanalysis.
This role demands an individual with a strong commitment to compliance, integrity, and excellence in bioanalytical research. The role reports into the Head / Group Leader, Small Molecule Bioanalytical Laboratory and is a full-time position based out of Bangalore, India.
Key Responsibilities of the Role:
- Perform data check (QC) for method development, validation and study sample analysis.
- Review STPs, Protocols, validation and bioanalytical reports.
- Ensure necessary documents and records are updated and make it ready for the audits (Sponsor / Regulatory).
- To handle Change Management, initiate change request as and when required.
- Undertake daily and monthly inspections in the Bioanalytical Research Laboratory as and when required.
- Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
- Discuss QC observations with the Project Leader / Group Leader / Head, BRL for corrective actions and verify the corrective actions.
- Prepare QC observation trend analysis and discuss with management on scheduled basis
Education and Experience
Education
M. Pharm / B. Pharm / M.Sc. in Pharmaceutical Sciences / Analytical chemistry or other related life sciences from a reputed university.
Industry Experience
- Minimum of 4 years of experience in regulated small molecule bioanalysis
- Hands-on experience in small molecule regulated bioanalytical experiments
People leadership experience
NA
Exposure and experience
Experience with working for a Bioanalytical CRO lab will be an added advantage.
Core competencies required for the role
- Scientific:
- Brings a creative and an innovative advantage to projects
- Is curious, eager to learn and make a difference
- Thinks scientifically and understands the problem statement in assigned programs/assays
- Publishes posters, papers and articles regularly
- Technical
- Review, reports/analyzes data punctually and communicates effectively
- ICH, FDA, EMA, ANVISA Method validation Guideline.
- Troubleshoots and investigates logically (is able to defend the logic behind experimental results)
- Is able to forecast risks and make mitigation plans ahead of time
- Has good organizational, project management skills
- Documentation
- Records data as per ALCOA++ policy
- Pays attention to detail
- Displays minimal audit finding index
- Writes clearly and concisely with English skills at >B+
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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Pls visit us at https://syngeneintl.com/ to know more about us and what we do.
JOB DESCRIPTION
Designation: Senior Executive - QC, Small Molecule Bioanalytical Research Laboratory
Job Location: Bangalore, India
Reporting to: Head / Group Leader of Small Molecule Bioanalytical Laboratory
Job Grade: Level 9-II
The Company
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
The Role
The Executive - QC for the Small Molecule Bioanalytical Laboratory is a technical role responsible for reviewing data for BA/BE studies in the laboratory. Job responsibilities include checking method development, validation and sample analysis data.
This role requires an individual with a robust background in pharmaceutics, or other related life sciences, coupled with extensive experience in the bioanalytical field, particularly within small molecule bioanalysis.
This role demands an individual with a strong commitment to compliance, integrity, and excellence in bioanalytical research. The role reports into the Head / Group Leader, Small Molecule Bioanalytical Laboratory and is a full-time position based out of Bangalore, India.
Key Responsibilities of the Role:
- Perform data check (QC) for method development, validation and study sample analysis.
- Review STPs, Protocols, validation and bioanalytical reports.
- Ensure necessary documents and records are updated and make it ready for the audits (Sponsor / Regulatory).
- To handle Change Management, initiate change request as and when required.
- Undertake daily and monthly inspections in the Bioanalytical Research Laboratory as and when required.
- Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
- Discuss QC observations with the Project Leader / Group Leader / Head, BRL for corrective actions and verify the corrective actions.
- Prepare QC observation trend analysis and discuss with management on scheduled basis
Education and Experience
Education
M. Pharm / B. Pharm / M.Sc. in Pharmaceutical Sciences / Analytical chemistry or other related life sciences from a reputed university.
Industry Experience
- Minimum of 4 years of experience in regulated small molecule bioanalysis
- Hands-on experience in small molecule regulated bioanalytical experiments
People leadership experience
NA
Exposure and experience
Experience with working for a Bioanalytical CRO lab will be an added advantage.
Core competencies required for the role
- Scientific:
- Brings a creative and an innovative advantage to projects
- Is curious, eager to learn and make a difference
- Thinks scientifically and understands the problem statement in assigned programs/assays
- Publishes posters, papers and articles regularly
- Technical
- Review, reports/analyzes data punctually and communicates effectively
- ICH, FDA, EMA, ANVISA Method validation Guideline.
- Troubleshoots and investigates logically (is able to defend the logic behind experimental results)
- Is able to forecast risks and make mitigation plans ahead of time
- Has good organizational, project management skills
- Documentation
- Records data as per ALCOA++ policy
- Pays attention to detail
- Displays minimal audit finding index
- Writes clearly and concisely with English skills at >B+
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 law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
Pls visit us at https://syngeneintl.com/ to know more about us and what we do.