PHARMACEUTICAL DEVELOPMENT TECHNICIAN, 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, 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).We are hiring a Pharmaceutical Development Technician based in our injectables plant in Azuqueca de Henares.Global ResponsibilityUnder the responsibility of the R&D Pharmaceutical Development Team Leader, the Pharmaceutical Development Technician will have the following functions:Proactively perform scientific literature search, review, and execute the experimental activities required 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 and 505b2 formulations.Generate test data to characterize trial formulations and execute pre-formulation, formulation, and process development trials according to GMP requirements.Support the interaction with raw material vendors to contribute to the selection of suitable quality for API, excipients, container closure systems and consumables (e.g., filters) to be used for development and manufacturing.Specific ResponsibilitiesActively participate in the design and/or follow pre-formulation (compatibility studies), formulation development, process development, process optimization / scale-up on assigned projects.Execute, interpret, and report experiments of the pharmaceutical development of injectable products, selection of primary packaging material and raw material qualities, development, and characterization of robust manufacturing processes for filling 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 in the evaluation of the process performance and technical performance in cooperation with the production department.Support the improvement of QbD development concepts, template, and procedures.Execute studies related to pre-formulation and formulation activities including but not limited to pH, solubility, dissolution studies, material compatibility, filter selection, terminal sterilization, lyophilization and simple analytical characterization activities.Execute and contribute to the interpretation and reporting of forced degradation studies, pre-stability studies and process characterization lab scale trials.Take care of handling machines and instruments, perform experiments, analyze, interpret, and properly record data, monitor operations during commissioning batches and installation of new equipment. Adhere to the equipment calibration plan ensuring instruments GMP compliance.Perform literature searches, extract relevant information from patents and other relevant scientific publications.Perform respective SAP or other software-based activities for assigned projects.Write protocols, reports, master batch records, as per ICH guidelines and regulatory requirements.Write Standard Operating Procedures.Collaborate and interact closely with the rest of the team members in Pharmaceutical Development department, the Analytical method development department and manufacturing department.Ensure good relationships and collaboration with all the other teams in QC, QA, Production, Regulatory Affairs etc.Ensure complete ownership of assigned projects and related activities until completion of projectsRequirements and personal skills· Education: MSc in Chemistry, Engineering or Pharmaceutical Sciences. PhD is an asset.· Languages: Good/Fluent level of spoken English and very good level in written communication. Spanish fluency is an asset.· Experience (years/area): Minimum 3-4 years of experience of Formulation development of Complex Injections (NDDS) and process development in the pharmaceutical industry and GMP environment is required. Experience in Pharmaceutical Development of sterile 505b2 formulations and NCE is an asset.· Travels: Ability to travel domestically and internationally.· Shift Change: Based on the project execution requirements working in different shifts is required.· 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.What we offerPermanent contractMarket salaryFree cantineFlexible schedule from monday to fridayLife and accident insuranceOthersCOMMITMENT TO EQUAL OPPORTUNITIESChemo is an equal opportunity employer.We do not discriminate against anyone on the grounds of ethnicity, religion, age, sex, nationality, marital status, affectional or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.