Sr. Scientist - Purification Process Downstream ( Biosimilar)

Enzene Biosciences Ltd.; Pune District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Enzene Biosciences Ltd. in Pune is seeking a Sr. Scientist - Purification Process Downstream (Biosimilar) to plan and execute downstream DSP activities for mammalian and/or microbial products.

Lead data interpretation and contribute to project meetings, with responsibility for documentation and tech transfer. The role requires deep purification expertise (chromatography, filtration, UFDF) and hands-on troubleshooting, along with DoE-based process development and regulatory awareness.

Qualifications

• Downstream process knowledge and hands-on troubleshooting ability for chromatography, filtration and related unit operations.
• DoE based process development experience.

Responsibilities

• Planning and execution of Downstream Process activities for mammalian and/or microbial products under supervision.
• Data interpretation and collaboration with reporting manager.
• Prepare and review DSP data presentations for project meetings.
• Represent department in internal and external meetings.
• Draft study protocols, development reports, SOPs and tech transfer documents.
• Troubleshoot issues at manufacturing post tech transfer.
• Coordinate with vendors/clients for technical queries.
• Scale-up/down and tech transfer activities; virus clearance studies.

Job description

Sr. Scientist - Purification Process Downstream ( Biosimilar) Pune, Maharashtra, India 12 - 15 Years Permanent (ENZBIO)

Job Description

Sr. Scientist is responsible for the planning and execution (wherever applicable) of downstream-related multiple projects with moderate supervision. The individual will report to Sr. Principal Scientist level and above and can have a reporting of few team members. the person has to work as downstream subject matter expert for one or more individual project.

What You Will Do:

• Sr. Scientist is responsible for but not limited to
• Planning and execution of Downstream Process activities for mammalian and/ or microbial products/recombinant protein along with team member under supervision of manager for multiple projects.
• to perform day to day planning of activities to be done by the team reporting to him/her, data interpretation in coordination with the reporting manager.
• Prepare and or review presentations of the DSP data and discuss in the respective project team meetings.
• Attending and representing department in internal and external (wherever applicable) meetings.
• Review/drafting of documentation activities like preparation of study protocols, development reports, BPR, SOP, tech transfer documents etc.
• Involve in troubleshooting of technical problems encountered at manufacturing post tech transfer.
• Responsible for Cross-functional communication with internal and external vendors/clients for technical queries in consultation with reporting manager
• Protein purification process development expertise and hands on experience with troubleshooting ability (Chromatography, Depth filtration, Centrifugation, UFDF, sterile filtration etc.) in mammalian/microbial expressed antibodies and/or therapeutic proteins.
• Experience in Process characterization using DoE Based process development
• Hands on experience on data analytics using different statistical tools will be added advantage.
• Experience of Scale up/ Down, Technology Transfer (TT) activities and virus clearance (VCS) studies.
• Involve in upkeeping the Lab in running state from equipment and compliance aspect. [Setup, operation, troubleshooting and routine maintenance of purification equipment’s (Chromatography system, pH/ conductivity meter, UFDF system etc)]
• Awareness of the domestic and regulatory requirements (CDSCO, EMA, US-FDA, etc.)
• Proficiency about awareness in protein analytical data interpretation and linkage with process parameters is an added advantage.