.About the job Position: Pharmaceutical Development Team Leader - Solid Pharmaceutical Forms Location: 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 R&D 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 R&D 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 R&D and to meet the standard approval flow established by the quality system; all in accordanceto 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