Piramal Pharma Solutions is seeking a highly skilled and experienced Senior Principal Scientist to join our dynamic team in Ahmedabad, Gujarat. As a leading Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Solutions offers comprehensive development and manufacturing services across the entire drug life cycle. This includes drug discovery solutions, pharmaceutical development services, and the commercial supply of active pharmaceutical ingredients (APIs) and finished dosage forms.
Position Overview
The Senior Principal Scientist will play a pivotal role in monitoring and managing analytical functions to ensure real-time support for cross-functional teams in various projects. This challenging and rewarding position involves a high level of responsibility and the opportunity to work on a range of innovative projects in the pharmaceutical industry.
Key Responsibilities
The successful candidate will be responsible for:
- Analytical Support and Monitoring: Liaising with cross-functional teams to ensure timely delivery of analytical output. Provide real-time analytical support for project timelines.
- Method Validation: Conducting analytical method validation for drug substances and various dosage forms, including tablets, capsules, oral solutions, suspensions, and injections, in compliance with ICH and other regulatory guidelines.
- Method Transfer: Overseeing method transfers according to regulatory guidelines (USFDA, MHRA, ANVISA, Canada, EU) across a variety of dosage forms, ensuring compliance with industry standards.
- Regulatory Compliance: Responding to queries raised by regulatory agencies, ensuring all deliverables meet required standards of safety and efficacy.
- Laboratory Setup: Establishing analytical laboratories adhering to cGLP/cGMP norms, and developing systems aligned with quality and regulatory requirements.
- Technical Development: Method development, validation, and technology transfer for nitrosamines and other genotoxic impurities using advanced techniques (LCMS, GCMS, HPLC, etc.).
- Cross-Functional Collaboration: Interacting with different sites within Piramal and external clients to provide necessary analytical support.
- Quality Assurance: Conducting internal audits and ensuring compliance with laboratory SOPs, computer system validation, and regulatory requirements.
- Budget Management: Monitoring the analytical requirements and preparing the OPEX and CAPEX budgets for the department.
- Data Integrity and GDPR Compliance: Ensuring data integrity in all analytical processes and compliance with data governance norms.
Required Skills and Qualifications
To be considered for this exciting opportunity, candidates should possess the following:
- Education: M.Sc. / M.Pharm / Ph.D. in a relevant discipline.
- Experience: Significant experience in analytical development within the pharmaceutical industry, with a strong background in nitrosamine testing and method validation.
- Leadership: Proven experience in team handling and leadership.
- Technical Proficiency: Strong knowledge of analytical techniques including HPLC, GCMS, LCMS, and advanced methods for impurity testing.
Why Join Piramal Pharma?
Piramal Pharma Solutions offers a collaborative and innovative work environment that prioritizes professional growth and development. As a Senior Principal Scientist, you will work on cutting-edge projects that make a meaningful impact on patients’ lives around the world.
For those driven by passion, excellence, and the desire to be at the forefront of pharmaceutical development, this role could be your next career milestone.
Application Details
Location: Ahmedabad, Gujarat
Department: Analytical Development
Application Deadline: 28th February 2025
If you are ready to take the next step in your career and make a difference in the pharmaceutical industry, we invite you to apply for the position of Senior Principal Scientist at Piramal Pharma Solutions today!
