Job Description
Join Piramal Pharma Solutions — A Global Leader in Advanced Drug Development & Manufacturing
Are you passionate about scientific excellence and quality in pharmaceutical development? Piramal Pharma Solutions, a leading global Contract Development and Manufacturing Organisation (CDMO), is seeking a dedicated Bio-Assay Scientist to join our innovative team.
About the Role:
As a key member of our Bio-Assay team, you will lead method development, qualification/validation, technical transfer, stability testing, and QC release activities. Your expertise will help ensure our products meet stringent quality and regulatory standards, supporting life-changing medicines worldwide.
Key Responsibilities:
- Prioritise daily tasks aligned with project objectives, guided by senior team members.
- Support routine Bio-Assay QC and stability testing, ensuring all activities follow SOPs, protocols, and cGMP standards.
- Review and verify data in compliance with Data Integrity and regulatory requirements.
- Maintain a compliant, organized laboratory environment that meets client, GMP, safety, and regulatory standards.
- Execute calibration, maintenance, and troubleshooting of laboratory equipment, promptly communicating any issues.
- Provide training and technical support to Development and Quality Control teams.
- Lead compliance and continuous improvement projects, identifying efficiencies and best practices.
- Plan workload effectively to meet project timelines and deliverables.
- Manage deviations, investigations, change controls, and ensure timely resolution and documentation.
- Escalate issues promptly to management to facilitate swift corrective actions.
- Assist in implementing measures and targets across release, stability, development, technical transfer, and validation activities.
- Promote cost-effective practices—optimizing labor, materials, and energy usage.
- Support onboarding and training of new staff members.
- Apply cGMP, Data Integrity, and ESH standards in all activities.
- Contribute to audit readiness and continuous improvement initiatives.
- Support equipment validation activities (IQ/OQ/PQ) and maintain system ownership.
- Draft, review, and update SOPs, protocols, and documentation.
- Identify opportunities for process improvements to enhance efficiency, safety, and GMP compliance.
Qualifications & Skills:
- Proven experience in bioassay method development, validation, and QC release.
- Strong knowledge of cGMP, Data Integrity, and regulatory requirements.
- Excellent organizational, troubleshooting, and communication skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Experience with equipment calibration, validation, and documentation practices.
Why Join Piramal Pharma Solutions
- Be part of a global organization committed to innovation, quality, and continuous growth.
- Work in a collaborative environment that values your expertise.
- Contribute to impactful projects that improve patient health worldwide.
- Enjoy opportunities for professional development and career progression.
Apply
Join us in advancing healthcare through science and innovation. Submit your application now and become a vital part of Piramal Pharma Solutions.