OneSource
Website:
onesourcecdmo.com
Job details:
Job Description: Senior Research Associate, Manufacturing Science and Technology (Downstream Processing)
Company: OneSource Specialty Pharma Limited Location: Doddaballapura, Unit-2, Karnataka [On-site] Department: Manufacturing Science and Technology Reports To: Downstream Head
About OneSource Specialty Pharma Limited
OneSource Specialty Pharma Limited is a premier, India-based, pure-play Contract Development and Manufacturing Organization delivering comprehensive end-to-end solutions, spanning complex biologics, injectables, drug-device combinations, and soft gelatin technologies. Operating out of state-of-the-art facilities in the Bengaluru region, partnering with global pharmaceutical companies to transform product concepts into market-ready therapies efficiently.
Role Overview
We are seeking a highly detail-oriented and communicative Senior Research Associate for Manufacturing Science and Technology to join our flagship Unit-2 facility. You will bridge downstream process development and commercial manufacturing, providing crucial support for both early phase and late phase product life cycles. This role requires a strong balance of desk-based technical analysis—exceptional documentation and data evaluation—with an active shopfloor presence to oversee the purification of the active drug substance from both microbial and mammalian cultures.
Key Responsibilities
Downstream Technical Documentation & Process Analysis
- Author, review, and revise critical downstream manufacturing documentation, including purification technology transfer protocols, scale-up documents, and comprehensive summary reports.
- Draft and execute process validation protocols specific to downstream processing, including mixing study, homogeneity studies and process intermediates hold-time studies.
- Extract and analyze statistical data for critical purification parameters to ensure process robustness, high yield, and high purity.
- Lead risk assessments (such as FMEA) and root cause analysis for complex manufacturing deviations.
- Manage change controls and corrective and preventive actions related to purification processes.
Shopfloor Presence & Execution
- Provide active shopfloor oversight during downstream technology transfers, engineering runs, and critical purification steps.
- Serve as the technical expert on the floor for complex downstream unit operations, including harvest and clarification, diverse chromatography modalities (Affinity, Ion Exchange, Hydrophobic Interaction), Tangential Flow Filtration, depth filtration, sterile filtration, and virus nanofiltration.
- Act as the primary technical troubleshooter on the manufacturing floor, rapidly resolving purification equipment or process issues to minimize downtime.
- Collaborate with operations teams to ensure downstream protocols are executed exactly as written across our flagship facility.
Cross-Functional Communication
- Serve as a downstream technical liaison connecting Process Development, Quality Assurance, Regulatory Affairs, and Manufacturing teams.
- Present purification data, technical summaries, and project updates clearly to internal stakeholders.
- Train junior team members on new downstream processes, purification equipment, and best practices.
Qualifications & Requirements
- Education: Bachelor’s or master’s degree in biotechnology.
- Experience: 4 to 5 years of relevant industry experience in downstream technology transfer and/or downstream process development. Experience working with biologics is preferred.
- Technical Knowledge: Proven experience handling the purification of drug substances for both microbial and mammalian cultures. Deep understanding of cGMP, scale-up principles, validation lifecycles, and bioprocessing equipment like automated chromatography skids and filtration systems.
- Documentation: Demonstrated track record of producing high-quality technical documents with strict adherence to QMS.
- Communication: Exceptional communication skills to translate complex purification data into clear, actionable instructions for shopfloor operators.
- Work Style: Comfortable spending significant time on the manufacturing floor while meticulously managing analytical and documentation tasks.
Click on Apply to know more.
