Senior Lead Scientist

Syngene International; Bengaluru; Sur place; INR 1 800 000 - 3 000 000; Plein temps

Résumé du poste

Syngene International Ltd. in Bengaluru is seeking an experienced Senior Process Development Scientist to drive process research from lab to pilot and commercial scale, delivering reproducible data and scalable, cost-effective processes.

You will generate data for robustness, collaborate with cross-functional teams, ensure safety, quality, and data integrity, and maintain thorough documentation to support scale-up and manufacturing transfer.

Qualifications

• Experience: 6-10 years in process development or related field.
• Ability to generate reliable data for scale-up.
• Strong collaboration and documentation skills.

Responsabilités

• Perform process research and development studies to generate reliable data for scale-up.
• Conduct experiments in lab and document results in the lab notebook.
• Generate data for process robustness, plant simulations, and safety studies.
• Collaborate with cross-functional teams to develop scalable, safe and cost-effective processes.
• Ensure safety, quality, data integrity and training compliance.

Description du poste

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Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene’s 4500+ scientists offer both skills and the 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 dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Responsibility Summary:

Performing activities at both lab and manufacturing facility to ensure the lab process safely transferred to pilot scale / commercial scale with reproducible results.

Primary Responsibilities:

• Responsible for performing process research and development studies to generate accurate and reliable data that would be used for scale-up batches


• Contribute individually (or as a team when appropriate) by performing experiments in lab and update laboratory notebook contemporaneously. Target minimum of two experiments in a working day at lab


• Perform experiments to generate data for process robustness, plant simulation studies, process safety studies, etc.


• Collaborate with CFT and delivery counterparts to develop scalable, safe and cost-effective processsuitable for pilot / commercial scale manufacturing.


• Record all minute observation while lab experimentations and transfer knowledge to execution team for flawless smooth execution.


• Synthesize reference standard, impurity markers, intermediates, and APIs to support method development in ADL and customers need from lab scale.


• Ensure effective utilization of the resources and tools for developing the process.


• Quick fixing of scale up challenges through scientific and operational excellency to meet project deliverables


• Ensuring 100% compliance in safety, quality, data integrity and trainings.


• Ensure individual contribution is met as per PRD guidelines


• Observe critically the batches while execution at manufacturing facility and provide valuable feedback to improve the process and avoid failure.


• Review the process documents like TTD, BMR, scale up studies, engineering studies, etc. to ensure the process is robust enough and all necessary data are available.


• Monitor the reactor days, batch input output data and collecting the analytical documents etc. pertaining to scale up batches


• Ensure flawless execution of scale up activities with 100% compliance on safety, quality and data integrity.

Experience: 6-10 years

Safety and Integrity

• Set and maintain high safety standards in the work environment.


• Adherence to all Environment, Health, Safety and Sustainability (EHSS) requirements always in the workplace with 100% compliance


• Ensure there are no Safety and environmental non-compliances in all areas that you are working in


• Reporting minimum of 1 near miss/observation per year. Ensure communication of incidents (or near-misses) and learning from those to ensure such an incident is not repeated/does not happen


• Ensure all the respective Kavach standards applicable to you are being meticulously followed


• Responsible for safety of self by ensuring all necessary safety protocols are adhered to


• Ensure all assigned mandatory LMS, classroom and on-the-job training related to Safety/EHSS are completed on time with 100% compliance


• Ensure all assigned mandatory LMS, classroom and on-the-job training related to Data Integrity are completed on time with 100% compliance

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 about 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.