PHARMACEUTICAL DEVELOPMENT MANAGER

Insud Pharma is a recognized 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 specialized in the research, development, manufacturing and commercialization 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 drugs 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 looking for a Pharmaceutical Development Manager based in our plant in Azuqueca de Henares. Global Responsibility Oversight, coordination, and responsibility for Chemo’s R&D projects (mainly oral solid forms) developed. The responsibility comprises all formulation and process development activities from pre-formulation to industrial stage as alignment with other functions within R&D (e.g. Clinical Development for biostudies) and outside R&D (e.g. Project Management, Regulatory Affairs, Purchasing, Business Development etc.).Review and approval pharmaceutical development, analytical, regulatory and clinical documentation records. Propose and justify the necessary human and technical resources changes and improvements needed within the team and to implement new development techniques and ways of working, according to current pharmaceutical guidelines, Pharmacopeia and SOPs, with the aim of developing new products, meet the deadline and technical assistance and conducting work defined by the R&D Associate Director.Contribute and collaborate with project development decisions based on the R&D data and all the R&D activities performed.Specific Responsibilities Manage, organize and supervise R&D development activities of External Developments and US Internal Developments, including personnel an annual goals and strategies for solving incidences.Verify/revise/approval all documentation generated by the project leaders/scientists and evaluate the results of different trials to generate new proposals for future activities and experimental work.Coordinate the technical side of R&D to perform the necessary work: analysis, analytical and testing transfers.Monitor exhibit/registration and industrial batches; approval proper implementation of process and ensure documentation and reports for the departments of Production, Regulatory and Quality Assurance.Ensure alignment of 3rd party project activities with internal functions within and outside R&D as well as with external customers.Propose changes in the annual planning and programming activities to meet deadlines and provide technical assistance to different departments. Elaborate calendars, schedule deadlines and understand impact of schedule changes.Communicate and present updates of the progress of the pharmaceutical development of each project to the R&D Associate Director.Prepare the annual budget and needs assessment for both, equipment and human resources, and actively participate in the recruitment and development of the team.Leading, training and coaching the team to achieve goals on development of Products which are set on the corporative level.Review, assist and cooperate in audits.Contribute to overall R&D outsourcing strategy and evaluate potential new 3rd parties, if needed.Manage and coordinate external developments, internal developments at pilot plant and the Analytical Department to ensure the proper advance of all the projects.Ensure the proper technology transfer (equipment available, batch sizes, etc.) from third parties to Liconsa when needed.Stablish fluent contact with Xiromed US team to be in line with the project development progress, focus on solid oral dosage forms. Nevertheless, other pharmaceutical forms could be developed.Present the project status to Top ManagementRequirements and personal skillsEducation: Pharmaceutical degree or PhD in Pharmacy, Pharmaceutical Sciences or related scientific degree in Chemistry.Languages: Fluent Spanish and English, knowledge of other languages will be an asset.Experience (years/area): +10 years of experience in formulation development and process development in the Pharmaceutical industry. +10 years of experience in Pharmaceutical Development of solid dosage forms. Significant experience in analytical development. Experience in GMP environment is required.Specific Knowledge: Pre & formulation, analytical and process development of pharmaceutical products (especially solid forms), upscaling and handover from R&D to Production. Regulations GMP, BPL, FDA, ICH Pharmacopeia (USP and EP), ISO 9001 and ISO 14001, and SOPs. Experience with drug product applications with the FDA & EU. Clinical and regulatory affairs experience desirable. Experience in people management and managing multiple projects.Travels: Open to travel.Personal skills: Good R&D and project management skills, proactivity, team development, leadership and creative with good problem-solving skills. Demonstrated ability to communicate and effectively interact with cross functional teams and outside teams. Excellent communication skills (oral, written and presentations).What we offer: - Permanent contract- Negotiable / based on experience salary- Flexible working day from Monday to Friday- Life and accident insurance- Co-payment (voluntary) private health insurance- Other benefits