SUN PHARMA
Location
Gurgaon | India
Job description
Position Summary :
Accountabilities: Accountable for thorough process understanding by generating and evaluating the data during lab scale experimentation and using the knowledge thus generating for a effective, trouble free technology transfer of the project meeting defined quantity and timeline. Scope: R&D, CRD division for Global API development (US/EU/JP/BRIC etc). Job Role Activities during lab development Evaluate raw materials/products/by-products and collect data for their safe handling, storage and disposal. Acquire thorough process understanding by observing batches at lab scale and collect/generate data for unit operations (reaction, distillation, extraction, crystallization, and filtration, drying) from scale-up point of view. Re-engineer difficult / hazardous unit operations using data from safety studies using DSC / TGA / Reaction Calorimeter. Conduct particle characterization studies using PVM and FBRM to assess impact of process parameters on morphology, particle size and distribution. Process Scale-up at Kilo Lab/Pilot Plant/Commercial Scale Coordinate activities between departments (CRD/GMS/AD/QA/QC) for raw material SAP code and requirement generation and procurement and testing. Identify hardware requirement for commercial scale using data available at Lab/ Kilo Lab / Pilot Plant scale. Evaluate / select plant facility, propose modifications and ensure timely completion of plant modifications for commercial scale as per process requirement. Conduct HAZOP analysis prior to start of batches at commercial scale to align with safety / environmental standards. Batch planning, scheduling and execution of batches at commercial scale (with necessary trouble-shooting) to ensure timely completion of technology transfer and delivery of development quantities. Solvent recovery and reuse Develop recovery method for spent solvent streams and conduct lab performance using recovered solvents to establish recyclability. Ensure recovery and reuse of spent solvent streams at commercial scale for cost-reduction and minimizing process waste. Effluent Treatment Plan Identify, collect and analyze process effluent streams. Develop effluent treatment / disposal plan for commercial scale to comply with existing environmental standards. Documentation Prepare and release Part-C (EHS Package), SRP (Solvent Recovery Package) and PED( Process Engineering Document) Assessment and Planning of Work To plan for the experiment in order to generate relevant process engineering and scale-up data for the projects. To plan for the execution of various day to day activities at various phases (lab/KL/PP/TT) in order to meet the delivery or completion timelines To review in detail, the works allocated to subordinates and discuss the technical problems faced Competencies Required : Technical Competencies: Thorough knowledge of chemical engineering unit operations, process design and scale-up. Awareness of regulatory guidelines (DRA, FDA, QA/QC, ICH). Knowledge of standard / quality guidelines (cGMP, GLP, internal SOPs). Software skills: Working knowledge of MS Projects, MS Visio, ChemCAD. Expertise in process simulation and DOE software. Behavioral Competencies: Poject execution skills Time management skills Problem solving Effective communication skillsJob tags
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