Process Characterization- Sr. Manager

Job Description

Role & responsibilities Process Characterization and Optimization : Quality by Design(QbD) approach and execute experiments for process characterization, including identifying critical process parameters (CPPs) that meets Product CQAs. Deep understanding on Cell culture and Purification Process with knowing Design space concepts, range studies and process fitment studies to achieve QTPP ranges. Thorough knowledge on designing process with knowledge on material attributes and process parameters for attaining Quality. Sound Knowledge on process characterization, use of PAT tools and statistical software for OFAT and multivariant study designs. Develop and optimize upstream and downstream purification processes for biosimilar products. Perform risk assessments and define process control strategies to ensure product consistency and compliance with regulatory standards. Data Analysis and Reporting : Analyze experimental data to establish process parameters and justify the design space. Develop comprehensive characterization reports and present findings to cross-functional teams. Use statistical tools for data analysis, process capability assessments, and troubleshooting. Regulatory Compliance and Documentation : Prepare detailed technical reports, batch records, and documentation for regulatory submissions. Participate in regulatory inspections, audits, and responses by presenting scientific rationale and documentation on process characterization. Drafting of CMC Dossier sections for Process characterisation for biosimilar products Cross-functional Collaboration : Collaborate with process development, analytical, and MSAT teams to ensure end-to-end process robustness. Contribute to project meetings, provide scientific input, and communicate project status, risks, and mitigation strategies to stakeholders. Preferred candidate profile Education : Masters or Ph.D. in Biochemical Engineering, Biotechnology, Biochemistry, or a related field. Experience : Minimum of 10 years in upstream/downstream process development or characterization in biopharma, with a focus on biosimilar or biologics. Technical Skills : Proficiency in cell culture techniques, including bioreactor operation, media development, and cell line maintenance Expertise in protein purification methods (chromatography, filtration, etc.). Experience in design of experiments (DoE), statistical analysis, and process modelling. Familiarity with regulatory guidelines (e.g., ICH Q8/Q9/Q10, FDA, EMA) and cGMP. Proficiency in data analysis software (e.g., JMP, Minitab, or similar). Soft Skills : Strong analytical skills, attention to detail, excellent communication and presentation abilities, and the capacity to work collaboratively across teams.