Senior Principal Scientist Position at Piramal Pharma- Apply before 28th February 2025

About Piramal Pharma

Piramal Pharma Solutions (PPS) is a leading Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions across the pharmaceutical lifecycle. With a global presence in North America, Europe, and Asia, we offer comprehensive services, including drug discovery, process development, clinical trial supplies, and commercial manufacturing of APIs and finished dosage forms.

Position: Senior Principal Scientist

Department: Analytical Development
Location: Ahmedabad, Gujarat
Qualification: M.Sc / M.Pharm / Ph.D.
Application Deadline: 28th February 2025

Key Responsibilities

Analytical Operations & Methodology

• Oversee analytical functions, ensuring real-time support for cross-functional teams to meet project timelines.
• Lead the validation of analytical methods for various drug substances and dosage forms, including tablets, capsules, oral solutions, suspensions, powders, and injectables, in compliance with ICH and regulatory guidelines.
• Conduct method transfer of analytical procedures as per regulatory standards (USFDA, MHRA, ANVISA, Canada, EU) for a wide range of formulations.

Regulatory Compliance & Quality Assurance

• Address regulatory queries from agencies such as USFDA, MHRA, and EU.
• Set up and maintain analytical laboratories in adherence to cGLP/cGMP standards and regulatory requirements.
• Ensure compliance with Standard Operating Procedures (SOPs), data integrity, and Good Documentation Practices (GDP).
• Conduct internal audits of cross-functional departments and report findings.

Advanced Analytical Techniques

• Develop, validate, and transfer analytical methods for nitrosamines, genotoxic impurities, and elemental impurities using advanced techniques (LCMS/HRMS/GCMS/ICPMS).
• Perform extractable and leachable studies using LCMS/GCMS/HPLC/ICPMS/IC.
• Identify and characterize unknown impurities through Prep LC, LCMS, and NMR.

Team Leadership & Strategic Planning

• Plan, monitor, and prioritize analytical activities in collaboration with internal teams and clients.
• Review and approve specifications, validation protocols, reports, and qualification documents.
• Drive digitization initiatives for analytical and cross-functional departments, including electronic lab notebooks (ELN) and sample management systems.
• Prepare and manage OPEX and CAPEX budgets for the department.

Required Skills

• Expertise in analytical functions and regulatory compliance
• Leadership and team management
• Specialized knowledge in nitrosamine analysis and impurity characterization

Why Join Us?

• Work with a globally recognized CDMO
• Engage in cutting-edge pharmaceutical research and development
• Lead innovative analytical projects with regulatory impact

Ready to make an impact? Apply now!

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