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 a DPI Analytical Team lead (AT) with a solid background in inhalation analytics and DPI development. The AT will be responsible for the set-up of our new Inhalation laboratory. The vision is to have a DPI Analytical team of up to six persons within a few years\' time. The AT will drive this project related expansion, and in parallel will execute on the existing projects. You will closely cooperate with DFE\'s Inhalation Manager Development and Support, who will be leading the customer projects on Inhalation. Furthermore, you will be in touch with the industry partners with whom DFE Pharma is offering development services. Do you have this combination of DPI analytical and formulation knowledge 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: Education / Experience High proficiency in English (spoken and written) and local language(s) Excellent understanding and experience of relevant analytical methods for physicochemical characterization (e.g. cascade impactor measurement, delivered dose, degradation products, particle size distribution and solid state characterisation). Excellent understanding of HPLC and proven troubleshooting record. Experience within Mass Spectroscopy and Gas Chromatography is also desired. Experience and understanding of method development and method validation. MSc/ PhD (preferred) in a related scientific field e.g. Biochemistry, Chemistry, Pharmacy, Physics, Biology, Bio pharmacy. Min. 10 years of analytical experience and desired experience in formulation in the respiratory field of the pharmaceutical industry (preferably carrier based DPI). Proven track record in respiratory developments (ANDA and/or NDA) and interaction with regulatory authorities/bodies (e.g. FDA, MHRA, CDSCO and EMA). Very familiar with relevant inhalation guidances to develop generic and innovation respiratory drug products. As well as general analytical development guidance for method development and drug product development. Excellent knowledge of GMP practise and GLP practise. Knowledge of formulation development strategies including principles of quality by design (QbD) and experimental design strategies (DoE). Complimentary Skills Taking ownership for all aspects of a project including preparing protocols and successful delivery of project milestones. Some of the skills required to achieve this are listed below: Project management track record Excellent analytical and problem solving skills Experience with leading and managing teams is desired. Strong listening and communication skills, with ability to convey complex scientific concepts through a variety of mediums to both scientific and non-scientific audiences. Stakeholder management skills to build strong connections with industry partners, sales and, the internal organisation What We Offer A dynamic work environment Direct impact on strategically important, international Inhalation projects 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 Team Details Together with the to be hired DPI Analysts, you will form a global leading DPI Analytical expert panel at DFE Pharma\'s Centre of Excellence You will report to the Director Centre of Excellence, with a functional reporting line to Inhalation Manager Development and Support You will be working at the Hyderabad CoE

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