Senior Executive

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 Level of Responsibility LowScope R D CRD division for Global API development US EU JP BRIC etc Dimension Development Projects 2-3 Technology transfer project 2-3Delegation of Responsibility Senior Manager DGMJob Profile 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 Problems Key FeaturesTo identify the critical process parameter and critical operating parameter for the various unit operation and to find engineering solution for their control for successful technology transfer Interface Internal CRD To discuss the process understand the reaction mechanism and critical parameters with respect to yield quality safety for planning experiments for generating hazard thermal other important data needed for scale up data at TD AD To get analysis done for recovered solvents critical reactions monitoring analysis which are studied at TD lab and analysis required in solid state properties data generation of API PDR To understand the specific requirement of PSD etc of API quantity required during EB batches of DF for ANDA filing DRA To finalize the specs of recovered solvents QA During EB campaign for BPR Exhibit batch protocol review QC During Technology Transfer campaign for reaction monitoring intermediate API analysis planning CQA Audit of PED lab note books etc GMS Procurement of RMs during lab development pilot EB campaign Accounts During purchase of capital items clearance of bills or vouchers from vendors travel statements etc Manufacturing Contract Manufacturing During planning of hardware RMs and batch execution during technology transfer campaign Admin HR Deal for help in EPMS training or any other work related to administration or HR External External vendors Academia Interact with vendors Academic institutions for utilization their available novel resources equipment software expert advice or consultancy for process development optimization scale up studies for safer environmental friendly and cost competitive technology development Contract Manufacturing Sites site visits to assess the suitability for non filings steps as per process requirement and campaign execution during technology transfer 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 Project execution skills Time management skills Problem solving Effective communication skills