About the jobPosition: Pharmaceutical Development Team Leader - Solid Pharmaceutical FormsLocation: Azuqueca de Henares.Experience: at least 5 years in similar functions.Do you want to know more?
INSUD PHARMA operates throughout the pharmaceutical value chain, providing expertise and experience in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF) and branded pharmaceuticals, with added value for human and animal health.INSUD PHARMA's activity is organized in three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotech (mAbxience), with more than 9,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized RD centers, 12 commercial offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries around the world.
INSUD PHARMA believes in innovation and sustainable development.Ready to be a #Challenger?What are we looking for?
We are incorporating a new INSUDER as a Pharmaceutical Development Team Leader to join the RD team at our plant in Azuqueca de Henares.The challenge!Plan, organize and coordinate the activities of pharmaceutical and analytical development to ensure the proper progress of the projects.
Assess and monitor activities of formulation scientists, analyzing and evaluating the results, to develop robust formulations and processes.Design, direct and/or follow pre-formulation (compatibility studies), formulation development, process development, process optimization / scale-up on assigned projects.Serve as a technical expert to select suitable formulation strategy and process development activities.Provide trouble shooting and optimization of formulations, process performance and technical performance in cooperation with the production department.Perform literature searches, extract relevant information from patents and scientific publications.Write and/or review protocols, reports, master batch records, technical transfer documents and other key documents as per ICH guidelines and regulatory requirements.Prepare product development reports, write and review quality overall summary and other documents to support CMC regulatory submissions for filing and answering to deficiency letters.Prepare and approve scientific documentation for quality and regulatory affairs to support projects assigned to RD and to meet the standard approval flow established by the quality system; all in accordance to GMP and CFR regulations, compliance with quality system and technical agreements and contracts with third parties so that projects progress properly.Prepare the annual budget and needs assessment for both, equipment and human resources, and actively participate in the recruitment and development of the team.Analyze the status of patents that affect products under development and the results obtained in the bioequivalence studies.Prepare summary reports and presentations for review by management.Collaborate and interact closely with the analytical development scientists and the manufacturing department.Supervise, motivate, coach and develop the team.Ensure good relationships and collaboration with all other teams involved in the development, QA, Patents, Medical, Regulatory Affairs, etc.Ensure good relationships and efficient follow up and tracking of development activities outsourced to third party organizations.Advice and report on ways forward for development, deviations and modifications of pharmaceutical formulations, according to SOP's, the ICH, EMEA, FDA guidelines, Annual Planning Projects and annual budgets, in order to reach the final product, ensuring that all parameters match production planning, decide future action in product development and get the results at the set time.QualificationsEducation: MSc Degree in Pharmacy, Chemistry or related scientific degree in Pharmaceutical Sciences.
PhD in Pharmaceutics is a plus.Languages: Fluent in English, basic knowledge of Spanish, knowledge of other languages will be an asset.Experience (years/area): +5 years of experience with formulation projects in the pharmaceutical sector.
Clinical and regulatory affairs experience desirable.
Proven leadership skills.
Experience in managing multiple projects and experience with FDA requirements desirable.Specific Knowledge: Knowledge of GMP regulations.
FDA.Travels: Open to travel.Personal skills: Impact and influence, good communication and project management skills, team leadership.Our benefits!Flexible entry time from Monday to Friday (full time 40 hours).
Indefinite term contract.
Attractive salary package.