Location
Secunderabad | India
Job description
This role requires a mixture of technical knowledge, experience and complimentary skills such as those detailed below:
- Excellent understanding and hand-on experience in the relevant analytical methods for physicochemical characterization such as, cascade impactor measurement ideally by NGI, delivered dose, degradation products, particle size distribution and solid-state Characterisation).
- Knowledge and hand on experience on HPLC and other relevant analytical instruments and proven troubleshooting record.
- Very familiar with relevant inhalation guidance s (e.g. FDA, MHRA, CDSCO and EMA) to develop generic respiratory drug products as well as general analytical development guidance for method development and drug product development.
- Ensure that all analytical development activities are thoroughly documented in the laboratory notebooks in accordance with company procedures and cGLP.
- Preparing analytical specifications and standard testing procedures for the developed methods.
- Preparing analytical method validation or verification protocols in accordance with ICH requirements, conducting validation as per agreed protocols, and preparing the corresponding reports.
- Excellent knowledge of GMP practise and GLP practise.
- Knowledge of analytical development strategies including principles of quality by design (QbD) and experimental design strategies (DoE).
What we offer - A dynamic work environment
- Working at a company that is market leader in inhalation and help to shape their future.
- Continuous learning and development; your development is not only good for your career; we also benefit from it.
- Short communication and short decision lines.
- An excellent remuneration package.
Vacancy description - DPI Analytical method development and validation as per the current regulatory requirement.
- Carry out lab experiments & trials based on plan drawn up by analytical team lead.
- Support in sample analysis and interpretation of results.
- Document all trials and prepare reports.
- Responsible for performing the qualification and calibration of various analytical instruments.
- Responsible to follow the cGLP procedures in the Lab.
- Basic concepts of analytical chemistry.
Education / Experience
- High proficiency in English (spoken and written).
- M. Pharma/MSc PhD in a related scientific field e.g. Biochemistry, Chemistry, Pharmacy, Physics, Biology, Bio pharmacy.
- Minimum 5 years of recent technical experience in the pharmaceutical industry, specifically in analytical development of DPI products (preferably carrier-based DPI
Team Details - Together with the Analytical team lead, will form a global leading DPI Analytical expert panel at DFE Pharma s Centre of Excellence.
- You will report to the Analytical team lead.
- You will be working in a new high end laboratory facility in Hyderabad, India.
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