Sr. Scientist - Purification Process Downstream ( Biosimilar)

Enzene Biosciences Ltd; Maharashtra; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

Enzene Biosciences Ltd. is seeking a Sr. Scientist to lead downstream process activities for mammalian and microbial recombinant programs, under moderate supervision.

The role focuses on planning, execution, and data-driven optimization of purification steps, with hands-on chromatography, filtration, and analytical methods, while coordinating with cross-functional teams and ensuring compliance. Experience in tech transfer, scale-up, and regulatory awareness (CDSCO/US-FDA) is valued, along with

Qualifications

• Experience in downstream processing for mammalian/microbial products.
• DoE-based process development and data interpretation.
• Knowledge of regulatory expectations and documentation standards.
• Strong communication and collaboration across teams.

Responsibilities

• Plan and execute downstream activities for multiple projects.
• Lead purification process development and troubleshooting activities.
• Prepare presentations and discuss DSP data in project meetings.
• Coordinate with internal/external teams and vendors for technical queries.
• Support tech transfer, scale-up, and process characterization activities.
• Maintain lab equipment and ensure regulatory compliance.

Skills

Downstream process development

Troubleshooting

Data analytics

Cross-functional communication

Tools

Chromatography system

pH/conductivity meter

UFDF system

Sterile filtration

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.