Manager -2 MSTG

2 weeks ago

Vadodara, Gujarat, India SUN PHARMA Full time

Job Title
Manager 2 – MSTG Non Orals

Business Unit
R&D1 Regulatory Affairs

Job Grade
G11A

Location :
Baroda

At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine? As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."

Job Description

  • Process Development and Optimization Support:(PRIMARY)
  • Partner with formulation scientists to ensure manufacturability and scale up feasibility.
  • Translate lab-scale batch data into pilot/scale-up strategies
  • Identify and define critical process parameters (CPPs) and key process parameters(KPPs)
  • Partner with FDD for process risk assessment (e.g, FMEA)
  • Partner with Process engineering MSTG/FDD and Conduct Scale Up studies and develop scale up model.
  • Technology transfer documentation:(PRIMARY)
  • Prepare tech transfer packages.(Process Optimization report)
  • Conduct Gap assessment between R&D and target manufacturing sites and prepare Gap assessment executive summary for review.(Equipment, utilities, SOPs)
  • Control strategy design:(PRIMARY)

Develop initial control strategies.

  • Process Modelling (Robustness and Optimization) (PRIMARY)
  • Use tools like QbD, DoE, and PAT to model and simulate processes before transfer.
  • Preform multivariate data analysis to assess robustness.
  • Exploration of PAT/Digital tools for non-oral portfolio processes
  • Analytical Method understanding:(CFT)

Collaborate with Analytical R & D for method robustness and comparability during transfer.

  • Support Regulatory fillings: (CFT)

Provide data and technical justification for regulatory submissions.

  • Troubleshooting and Investigations: (Scale up/EBs) (PRIMARY)

Address deviations, out of spec (OOS) and process failure with root cause analysis.

  • Continuous Improvement:(CFT)

Reduce cycle time, enhance robustness using Lean Six sigma.

  • Support to QA/Regulatory:(CFT)

Provide technical input for regulatory inspections, response to deficiencies and audit queries.(Development Related)

Travel Estimate
NA

Job Requirements
Educational Qualification
M.Pharm

Experience
Tenure : Minimum 9 years

Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

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