MSAT- Upstream

JOB DESCRIPTION

Designation: Associate Scientist

Level: 8- I

Job Location: Bangalore

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.

Key Result Areas

Role-specific:

Functional Responsibilities:

• Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
• Monitor & confirm that the established Environment Occupational Health Safety and Sustainability (EHSS) practices for safe work environment are followed by self & direct reports.
• Monitor & confirm that self & direct reports adhere to the highest standards of quality integrity & compliance for every work activity.
• Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the direct reports.
• Attend all assigned mandatory trainings related to data integrity health and safety measures and monitor & confirm the same for the direct reports.
• Participate in & support the trainings on procedures protocols and On-the-Job activities.
• Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
• Participate in & support for on-time initiation & closure of deviations investigations CAPA and change controls.
• Preparation and review of TTDs SOPs PDRs & Protocols.
• Review of Batch Manufacturing Records protocol and Quality Department Protocols related to Operations.
• Investigation of Batch failures in Operations.
• Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
• Update the batch progress in PRMs and participate in client discussions.
• Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.
• Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

Primary Responsibilities:

• Project Ownership: Accountable for the successful execution of projects from initiation through completion ensuring all deliverables meet client expectations and regulatory standards.
• Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements thereby safeguarding product quality and patient safety.
• Team Leadership: Mentor and guide junior team members fostering a collaborative and innovative environment that encourages professional growth and development.
• Performance Metrics: Monitor and report on key performance indicators (KPIs) related to process efficiency project timelines and quality metrics ensuring continuous improvement.
• Client Satisfaction: Ensure high levels of client satisfaction through effective communication timely updates and proactive problem-solving.
• Compliance and Risk Management: Identify and mitigate risks associated with technology transfer and process scale-up ensuring that all operations are compliant with internal and external guidelines.
• Deliver high-quality statistical analysis and reports to support process optimization.
• Develop and validate process maps and models in collaboration with cross-functional teams.
• Adapt to additional tasks and responsibilities as assigned demonstrating flexibility and a proactive approach.

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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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