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Aurobindo Pharma Ltd (APL). APL is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$650Mn, with presence in more than 22 countries across the globe. APL produces a wide range of Active Pharmaceutical Ingredients (API’s) and Finished Formulations which is marketed in more than 108 countries across the globe
Job Title: Process Characterization – Biologics R &D
No of Posts: 4
Location: Hyderabad / Secunderabad
Eligibility: B.tech / B.E/ M.tech Biotech , Biochemistry
Experience: 2 – 7 Years
Job Description:
- Develop experimental design strategies (DOE) for process characterization/development using Quality by Design (QbD) to assess critical process parameters, define design space, and establish operating ranges for clinical and commercial manufacturing.
- Support process performance qualification (PPQ) and method qualification/validation through study protocol design, setting of acceptance criteria, and analysis.
- Perform equivalence testing (Two One Sided TestS, TOST) to assess analytical similarity and process/method comparability including statistical justification for equivalence acceptance criteria.
- Experience with advanced statistical concepts such as Analysis of Variance (ANOVA) / Analysis of Covariance (ANCOVA), Design of Experiment (DOE), Response Surface Methodology (RSM), equivalence testing, Variance Components Analysis (VCA), mixed models, Random Coefficient Model (RCM), and Multivariate Analysis (MVA).
- Fluency in SAS, JMP, and R statistical software packages
- Excellent verbal/written communication skills to convey statistical analyses via oral presentation and formal written reports to audience/readers that may have varying backgrounds in statistics.
- Familiarity with regulatory and industry guidelines (ICH, FDA, EMA) applicable to biopharmaceutical drug development and manufacturing.
- Understanding of biologic product development, bioanalytical methods, and cGMP biologic manufacturing.
