Location
Secunderabad | India
Job description
DFE Pharma has a strong and leading position in inhalation grade lactose and is recognized for its high product quality and world class application expertise.
DFE Pharma is expanding its services portfolio and together with renown industry partners, we are offering development services for DPI.
The analytical part of this development work will be done in DFE Pharma's Centre of Excellence laboratory in Hyderabad, India.
We are looking for laboratory-based Analytical Scientist with a laboratory background to perform a range of experiments on API, excipients, and Dry Powder Inhalation dosage forms.
In this position, you will utilize diverse scientific methods and techniques to analyze the DPI samples and assess the product's quality. You will be part of a brand-new, state-of-the-art Technical Centre of Excellence located in Hyderabad, India. Do you possess both strong analytical expertise and a strong motivation to provide meaningful solutions for DFE Pharma's customers
Do you have DPI analytical experience, and do you like to be a major impactor on our growth journey
Now it is your chance to join!
What We Ask 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 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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