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.
Level of Responsibility: Low
Scope: R&D, CRD division for Global API development (US/EU/JP/BRIC etc).
Dimension: Development Projects: 2-3, Technology transfer project: 2-3
Delegation of Responsibility: Senior Manager/DGM
Job 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 Features
To 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