Principal Scientist Bioresearch Laboratory
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Posted on:
13 hours ago
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1 Vacancy
Job Summary
JOB DESCRIPTION
Designation: Principal Scientist Small Molecule Bioanalytical Laboratory Translational and Clinical Research
Job Location: Bangalore India
Reporting to: Head of Bioanalytical Laboratory
Job Grade: Level 5
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. Syngenes 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 Study Director/ Group leader/ Manager for the Small Molecule Bioanalytical Laboratory is a technical leadership role responsible for overseeing studies conducted in the laboratory. Job responsibilities include performing critical method development and validation programs technical and regulatory compliance of all studies.
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 particularly in small molecule analysis. The role reports to the HOD Small Molecule Bioanalytical Laboratory and is a full-time position based out of Bangalore India.
Key Responsibilities of the Role:
- Working with a collaborative bioanalytical team of analyzing scientists for the development validation and sample analysis for NCEs and Generics using the LC-MS/MS in support human studies.
- Monitor the day-to-day activities conducted in the laboratory like method development method validation and study sample analysis and also guiding the Project Leaders/Scientists/Research Associates.
- Review method development and validation protocols method validation reports Study sample analysis protocol and Bioanalytical reports.
- Ensure regulatory compliance across all bioanalytical programs adhering to GLP/ GCP.
- Ensure the technical compliance of programs by adhering to latest guidelines and white papers maintaining high-quality deliverables and adherence to project timelines.
- Independently manage studies and team from executing studies to technical data review analysis and interpretation using advanced software tools.
- Engage in technical forecasting troubleshooting client interactions and strategic planning to ensure the successful execution of programs.
- Work collaboratively across various functions within the laboratory and departments within Syngene - BD Quality Logistics etc.
- Participate in cross-functional project meetings to represent bioanalytical research services.
- Oversee performance management and assessment of reporting staff fostering a culture of excellence and continuous improvement.
Education and Experience
Education
Masters or PhD in Pharmaceutical Sciences from a reputed university.
Industry Experience
- Looking for a seasoned professional with years of direct experience in small molecule bioanalysis with a strong focus on LC-MS/MS based assays.
- Demonstrated success in regulatory audits and dossier submissions related to bioanalytical studies.
- Experience in a GCP/GLP bioanalytical laboratory
People leadership experience
Proven ability in leading developing and managing teams
Exposure and experience
Experience with working for a Small Molecule Bioanalytical CRO lab will be an added advantage.
Experience with developing and validating LC-MS/MS methods for large molecules will be an added advantage.
Hands-on experience on Watson LIMS 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
- Understands the MOA of the drug the patient population and the related assay strategy
- Publishes posters papers and articles regularly
- Technical
- Conducts/plans experiments without errors and gaps
- Reports/analyzes data punctually and communicates effectively
- 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 and client engagement skills
- Documentation
- Records data as per ALCOA policy
- Pays attention to detail
- Is punctual in responding to QC and QA reports
- 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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.
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About Company
We are an innovation-led contract research, development and manufacturing organization offering end-to-end solutions to fulfil R&D and manufacturing requirements of our clients
