Title:  Process Development Scientist

Designation:  Process Development Scientist

Job Location: Bangalore

About Syngene:  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, Safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and sops, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to development of procedures, practices and systems that ensure safe operations and compliance to company’s integrity & quality standards.
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals.
• Govern and Review safety metrics from time to time.

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:

• 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 process suitable 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.
• Generate projects documents like TTD, development report / campaign report
• 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.

Qualification: MSc Chemistry

Experience: 6 - 10 years

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.