Title:  Senior Executive

Job Description

Name: Mr. Vishesh Patel

Position Title: Executive ( Process engineering )  Technology Development - Baroda

Designation of the Incumbent: G11B

Reports to     :           <Sr.Manager/DGM/GM>

Supervises       :           < Research associate>

Position Summary:    

Accountabilities: Accountable for thorough process understanding by generating and evaluating the data during lab scale experimentation and using the knowledge for generating an 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: 1-2

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 (Particle Vision and Measurement) and FBRM (Focused Beam Reflectance Measurement) to assess impact of process parameters on morphology, particle size and distribution.
• Process Scale-up at Kilo Lab/Pilot Plant/Commercial Scale
  • 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-need based).

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.
• RA: 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.
• R&D-QA: Audit of Documents / 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: To complete Performance Appraisal activities, 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-filing/filing 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.
• Knowledge of standard / quality guidelines (cGMP, GLP, internal SOPs)
• Awareness of regulatory guidelines
• Software skills: Working knowledge of MS Word, MS Excel, MS Visio etc.
• Expertise in process simulation studies.

Behavioral Competencies:

• Project execution skills
• Time management skills
• Problem solving
• Effective communication skills

Name of the Job Holder                                              Signature                                 Date

Sandeep J Somaiya

Name of the Immediate Superior                               Signature                                 Date