Site MSAT Head

Purpose:

• The position is responsible for managing Process engineering, Process safety and Tech transfer activities and will interface between APSL and CTO3 for the smooth transfer of process technology and execution of clinical phase projects.
• Requires regular interaction with clients/customers during the execution of projects at manufacturing site and provides high level of project update on regular basis.
• Provide technical inputs for RFPs and align with site technical team on products mapping and scheduling.
• Estimate Capex requirements and coordinate with site ESD for Capex execution.

Roles and Responsibilities

Scale up and Manufacturing

• Ensure pre tech transfer activities in line with project requirement. (modifications, new equipment procurement etc.); Ensuring the team will prepare the plan for project execution and monitor the schedule.
• Guiding and mentoring Investigations and finalization of appropriate CAPA within timelines; Discussing with PMs providing timely support and technical inputs for the project movement and ensuring timely delivery of projects.
• Interact with MSAT team and ensure modifications, BPR preparations and all activities to meet delivery time lines
• Ensuring Plan vs Actuals are met for all the deliverables.

Lab Optimization

• Guide and ensure adherence towards optimization & scale-up, ensure relevant process of safety studies & capture all engineering information prior to the scheduled Tech Transfer
• Analyze safety evaluation reports generated for APSL molecules in terms of any hazards and Ensure relevant process of safety studies & capture all engineering information prior to the scheduled Tech Transfer
• Guide and mentor the team on process improvisation from scale up point views

Facility readiness:

• Evaluation of Facilities in terms of Technical Capabilities to fit Processes in order execute the projects
• Ensure Preliminary audits for the facility for any customer audits
• Ensure on time delivery and approvals of all equipment’s to ensure smooth and uninterrupted plant functioning.

Coaching and Mentoring

• Impart training on critical / complex technical areas to enhance team’s skills and performance.
• Provide learning opportunities for the team members by organizing lectures and knowledge sharing sessions    

Technical Requirements:

• Strong Domain expertise in Process Development and scale-up Activities.
• Expertise in Process Safety methodologies
• cGMP Manufacturing systems Understanding
• ICH & Regulatory Issues related to New product development and Manufacturing.

Soft skill Requirement:

• Communication, Time management, Adaptability, Interaction with Marketing team and other CFTs,  Understand the customer specifications.

Desired Candidate Profile

• Good chemical engineering knowledge on unit operation like Reaction , Distillation, Crystallization and Isolation
• Candidates should have experience in successful transfer of manufacturing process from development to clinical trials to full-scale commercialization.
• Process engineering knowledge on Mixing, Distillation, Filtration, Drying
• Thorough process understanding of API Scale up and Technology transfer.
• Capacity calculations and equipment evaluations.
• Gantt chart preparation

Education and Experience

B Tech-Chemical Engineering with 15+ yrs of work experience preferably with 8 to 10  years in the pharmaceutical industry with experience

Key Personal Attributes:  

• A focused driver with a structured process approach and ability to deliver outcomes.
• Passionate about people development, strong communicator, highly energetic with ability to influence & persuade others.
• Excellent interpersonal skills – High level of proficiency in networking & connecting internally and externally.