DRUG PRODUCT DEVELOPMENT SCIENTIST - R&D - INJECTABLES

Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector, with more than 40 years of history and more than 7,000 employees in 50 countries, specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.Chemo, an industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).Global ResponsibilityUnder the responsibility of the R&D Associate Director, R&D Injectables, the Drug Product Development Scientist will have the following functions:Proactively perform scientific literature search, review, and execute the experimental activities required for packaging during the formulation and process development of injectable drug products (Conventional and Complex Injectable products) of different pharmaceutical sterile forms varying from aqueous & oily solutions, suspensions, Nano suspensions and Peptide formulations, lyophilized and depot formulations.Generate test data to characterize packaging materials and conduct experiments as per the need of packaging materials.Support the interaction with packaging material vendors to contribute to the selection of suitable quality for container closure systems and secondary packaging materials to be used for development and manufacturing.Specific ResponsibilitiesHandling of parenteral packaging development activities for both Spain and Chemo India R&D’sPackaging material Characterization for RLD / RS product, Conducting literature survey.Selection of packaging materials for parenteral dosage form.Preparation/review of all documents related to container closure system.Preparation/review of packaging development reports.Method development of required functionality test for container closure system and - Preparation and review of respective documents.Identification of new Packaging Material vendor or new equipment whenever applicable.Handling of SAP activities related to packaging materialsProcurement of the packaging materials all other requirements for packaging material, by coordinating with purchase department.Planning and supporting the formulation development team for day-to-day activities related to container closure system.Preparation/review of SOP’s related to Packaging development.Coordination with cross functional team of chemo India and Spain for all container closure related activities.Preparation/Review of technology transfer documents (protocols, reports, master batch packaging records, as per ICH guidelines and regulatory requirementsTo support regulatory filing and Handling of all agencies queries.Technology transfer to the manufacturing sites.Execute, interpret and report experiments of the pharmaceutical development of injectable products, selection of primary packaging material qualities, development and characterization of syringes, vials, cartridges, etc.Support the transfer of the manufacturing processes to large-scale GMP facilities and support process validation, if needed attending production runs, participate to the evaluation of the large-scale data in close collaboration with production site team and the R&D team members.Proactively contribute to the implementation of internal R&D templates and procedures.Contribute to the troubleshooting and optimization of formulation, actively participate to the evaluation of the process performance and technical performance in cooperation with the production department.Collaborate and interact closely with the rest of the team members in Pharmaceutical Development department, the Analytical method development department and manufacturing department and other cross functional teams.Ensure good relationships and collaboration with all the other teams in QC, QA, Production, Regulatory Affairs etc.Any other work allotted by HOD or immediate Supervisor.Competencies/Career levelInnovation, communication, teamwork, adaptability/flexibility, sense of urgency, initiative, productivity, customer orientation, self-development.Requirements and personal skillsEducation: Bachelor’s or master’s in science, Packaging development, Engineering or Pharmaceutical Sciences.Languages: Good/Fluent level of spoken English and very good level in written communication. Spanish fluency is an asset.Experience (years/area): Minimum +5 years of experience of Packaging development of Injectable products or other products in the pharmaceutical industry and GMP environment is required. Experience in Packaging Development of sterile formulations, Pen Device, Auto Injector is an asset.Travels: Ability to travel domestic and international.Personal skills: Proactive, creative with good problem-solving skills. Demonstrated ability to communicate and effectively interact with cross functional teams and outside teams. Strong ownership of assigned tasks.COMMITMENT TO EQUAL OPPORTUNITIESThe InsudPharma Group is aware that business management must be in line with the needs and demands of society, and therefore assumes a commitment to equal opportunities and equal treatment between men and women, as set out in the current legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.