Descripción de la oferta
In shortAsegúrese de presentar su candidatura con toda la información solicitada, tal como se expone en la descripción del puesto a continuación.Position: Clinical DevelopmentLocation: Azuqueca de Henares.Experience: 3 to 5 years in similar roles.Want to know more?INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sales, and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs), and branded pharmaceutical products, adding value to human and animal healthINSUD PHARMA's activity is organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with more than 10,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical affiliates, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable developmenWhat are we looking for?We are looking for an Analytical Development Scientist to join our team and support the development of injectable drug products. In this role, you will be responsible for developing, validating, and transferring robust analytical methods for formulations and raw materials, ensuring compliance with project timelines, GMP standards, and regulatory requirements. You will play a key role in supporting formulation development, stability studies, quality control activities, and analytical investigations, while coordinating internal and external analytical work performed by CROs and partner laboratorThe challenge!Develop, optimize, validate, and transfer analytical methods for injectable drug product formulations and raw materials.Support formulation development, stability testing, and quality control activities through reliable and robust analytical methodologiesCoordinate and follow up analytical development, validation, and transfer activities performed internally or outsourced to CROs in Spain and other countriesEnsure successful analytical method transfer to Quality Control laboratories.Perform analytical investigations and troubleshooting to support development, validation, and transfer activitiesWrite and review analytical protocols, specifications, reports, and work bulletins.Evaluate analytical results and coordinate laboratory analysts' activities.Review and report analytical work performed by other departments, group companies, and external third parties.Prepare analytical documentation to support regulatory and clinical activities.Manage verification and testing methods for raw materials in line with project deadlines.Coordinate and review the work carried out in the Analytical Development Laborlines.Oversee Analytical Development Laboratory equipment management.Specific Knowledge:Strong knowledge of analytical instrumentationSolid expertise in chromatography techniques: LC, GC, and SEC.Good experience with Mass Spectrometry (MS).Sound knowledge of GMP, ICH, FDA, and USP/EP pharmacopeiasGood spoken English and very strong written communication skills in English and Spanish fluencyExperience (years/area):At least 3 years of experience as an Analytical Development Scientist in the pharmaceutical in Industry at least 3 years of hands-on experience in Liquid Chromatography, within a GMP environment. Strong experience with HPLC; UPLC is consideredExperience in the characterization of parenteral depot formulations is a a plus.Expertise in USP Type IV dissolution apparatus is a plus.EducationMSc in Analytical Chemistry or a related scientific discipline with strong chemistry content, or Pharmacy degree with relevant professional experience in analytical development.OurBenefits!Flexible start hours from Monday to Friday (full 40-hourworkweek).Permanent contractAttractive salary package.Life and accident insurance.Company cafeteria (free of charge).Co-payment for voluntary health insurance.Benefits and Savings Club.Development plans, internal mobility policy.Andmuch more!How will the SelectionProcess be?Stay alert to your phone and email! Most likely, the first thing we will do is contact you through one of these two channels.Prepare well! We will continue with a face-to-face/virtual interview based on availability and as agreed; there may be one or two interviews, and depending on the type of process, there may also be some kind of test.Wait for the result! We care that you feel guided and know what to expect from us at every step of the selection process, so we will always try to inform you about the status of the process.Do you think this offer is notfor you?Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we post. Your opportunity to become a new Insuder is waiting! xkdbapo #InsudPharma #Challenger #Insuder #Insud TalentCOMMITMENT TO EQUAL O PPORTUNITIESThe Insud Pharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as established in current regulations - Organic Law 3/2007, and we do not discriminate against anyone based on ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
