Job Description

JOB DESCRIPTIONDesignation: Research ScientistLevel: 7- IJob Location: BangaloreThe CompanySyngene 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.Key Result AreasRole-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.
• Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• 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, revision and review of Batch Manufacturing Records (BMR), Packing and Dispatch Record (PDR).
• Issue, Checking and Review of Operations documents.
• Preparation and review of Batch Manufacturing Records, SOPs, PDRs & Protocols.
• Conduct training for all DSP employees for prepared BMRs, PDRs and related documents.
• Review of TTD's, protocol and Quality Department Protocols related to Operations.
• Investigation of Batch failures in Operations.
• Monitor and follow good aseptic behavior inside BMP1 DSP Facility.
• 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 PRM's and participate in client discussions.
• Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.

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.

.Equal Opportunity EmployerIt 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 to know more about us and what we do.

Syngene International