TS/MS Principal Scientist – Dry External

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a senior technical leader to guide scientists and cross-disciplinary teams in delivering compliant production operations. You will interface with TS/MS, development, customers, and contract manufacturers to drive projects that improve process control, yield, and productivity.

The role requires 10+ years of experience ensuring cGMP compliance across production. Strong mentoring skills and regulatory acumen are essential in this senior position.

Qualifications

• Bachelor's or Master's Degree or equivalent in Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Materials Science, or Engineering.
• Minimum of 10 years of demonstrated experience delivering and assuring cGMP compliance of a production operation.

Responsibilities

• Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.
• Maintain interface with the TS/MS function, development, customers, and contract manufacturing organizations.
• Manage TS/MS technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, and/or productivity.
• Provide technical support for preparation of relevant technical documents: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Review/approve relevant technical documents: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
• Remain current with all applicable regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations).
• Provide support to internal and joint process teams.

Skills

Technical leadership

Mentoring

Regulatory compliance

Education

Bachelor's or Master's in Pharmacy/Pharmaceutical Sciences or related

Job description

Responsibilities

• Serve as a technical leader and mentor for Scientists, Managers, and other disciplines.
• Maintain interface with the TS/MS function, development, customers, and contract manufacturing organizations.
• Manage TS/MS technical projects (experimental, modeling, and/or production data analysis) to improve process control, yield, and/or productivity.
• Provide technical support for preparation of relevant technical documents: technical reports, change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, etc.
• Review/approve relevant technical documents: Change Controls, Regulatory Submissions, Expert Opinions, Deviations, Validations, Tickets, Procedures, PFDs, etc.
• Remain current with all applicable regulations (global GMP expectations, regulatory expectations, health, safety, and environmental regulations).
• Provide support to internal and joint process teams.

Qualification & Experience

• Bachelor's or Masters Degree or equivalent work experience in scientific disciplines of Pharmacy, Pharmaceutical Science, Pharmaceutical Engineering, Biochemistry, Organic Chemistry, Physical Chemistry, Bioanalytical Chemistry, Microbiology, Analytical Chemistry, Materials Science, or Engineering.
• Minimum of 10 years of demonstrated experience aligning with delivery of and assuring cGMP compliance of a production operation.