Downstream Scientist MSAT

Job Title: Downstream Scientist MSAT

Department: Biopharmaceutical MSAT

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

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.

Job Summary :

Incumbent will support the MSAT, Manufacturing team at Syngene with  technology transfer, raw material assessment, scale-up and technical support for batch manufacturing. The Scientist will also need to represent Syngene in presenting data to clients.

Primary Responsibilities:

Common Responsibilities:

• Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the reports.
• Attend all assigned mandatory trainings related to data integrity, health, and safety measures, and monitor & confirm the same for the 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.
• To perform the activities related to downstream technology transfer, scale up, process performance qualification (PPQ), technical deviation investigation, process trouble shooting and technical report writing.
• To execute technical instructions, data analysis and interpretation.
• Adherence to Standard Operating Procedures and Operational Control Procedures

Safety and DI Responsibilities:

• Adhere to organizational policies & procedures on EHSS, POSH, Data Integrity and IT security, and monitor & confirm the same for the reports.
• Always wear the applicable PPEs and adhere to any other Environment, Health, and Safety (EHS) requirements in the workplace for individuals & lab/plant safety and monitor & confirm the same for the reports.
• Understand all necessary safety protocols and always follow the same to ensure safety for all and monitor & confirm the same for the reports.
• Proactively identify near-misses & potential incidents and communicate the same to supervisor and/or line manager or through the respective portals and disseminate learnings from those to the team members & any other concerned personnel to prevent recurrence of such events.

Specific Responsibilities:

• Plan, coordinate, execute the internal and external technology transfer initiatives.
• Preparation and review of TTD/PPQ protocol etc.
• Review of BMR, reports, development TTD, client documents etc.
• Participate in deviation and OOS/OOT investigation and perform/support related experimentations.
• Provide shop floor support for technology transfer, scale up and process performance qualification related activities. 
• Author technical documents.  Documentation includes gap analysis, facility and process risk assessment, TTD, PPQ protocol, RM specification, statistical data analysis and other related technical documents.
• Process Monitoring, process data compilation, trending and analysis from engineering and cGMP campaign and authoring of summary reports.
• Trouble shooting of process/product related technical issues.
• Coordination with cross functional teams.
• Provide on spot solution for technical issue during campaign.
• Identify process improvement needs. Propose, plan, execute and implement the process improvement in the existing and upcoming processes.
• Evaluation of new technologies to reduce cost, improve manufacturability and propose for implementation.
• Shop floor technical support for process validation and process characterization.
• Execution of laboratory experiments and documenting them in detail in laboratory notebook as per the requirement.

Education & Qualifications:

Bachelors in Biotechnology/ Chemical Engineering with ~5 years of experience or

Masters in Biotechnology/ Chemical Engineering with ~3 years of experience or

Skill sets: Downstream Scale-up, Technology Transfer, Manufacturing, Process Development, Biopharma Process Improvements, Problem solving and investigation skill sets, Process monitoring.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.