Senior Scientist Drug Product / Final Product Development for Small Molecules.

About the RolebrU kunt meer details krijgen over de aard van deze vacature en wat er van sollicitanten wordt verwacht door hieronder te lezen.brpAs a Senior Scientist – Small Molecule Drug Product / Final Product (DP/FP), you will act as the subject matter expert (SME) for DP and FP manufacturing of Pharming’s small molecule portfolio. You will lead the development, scale‑up, validation, and transfer of drug product processes, as well as the design of primary and secondary packaging for final products. /pbrpWorking closely with Contract Manufacturing Organizations (CMOs), you will play a critical role in bringing products from clinical development through to commercial launch. As part of the Chemistry, Manufacturing Controls (CMC) team, you will contribute to defining and executing development strategies that ensure successful regulatory approval and commercialization. /pbrKey ResponsibilitiesbrpExecution Leadership /pbrullibr/liliIndependently lead the design and execution of advanced studies for development, scale‑up, validation, and process transfer of small molecule drug products.br/liliDrive the design and implementation of primary and secondary packaging solutions.br/liliManage external CMOs for development, manufacturing, and validation of clinical and commercial batches.br/liliRepresent DP/FP expertise within cross‑functional CMC teams, aligning strategies with overall development goals.br/liliPlan, prioritize, and deliver work to meet timelines and budgets.br/liliAuthor and present scientific reports, technical documentation, and updates to internal and external stakeholders.br/liliEnsure knowledge transfer across teams and mentor junior scientists.br/liliSupport business development activities by assessing manufacturing implications.br/li /ulbrpRegulatory Compliance Quality /pbrullibr/liliOwn and manage complex deviations, CAPAs, and change controls, ensuring timely and compliant resolution.br/liliTroubleshoot manufacturing challenges and deliver innovative, science‑driven solutions.br/liliStay current on regulatory requirements (EMA, FDA, ICH) and emerging industry trends.br/liliWrite and review development reports, validation documentation, and CMC dossier sections (IMPD, IND, NDA/MAA).br/liliAct as SME in interactions with regulatory authorities, addressing complex questions.br/li /ulbrYour ProfilebrEducationbrullibr/liliPhD or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline.br/li /ulbrExperiencebrullibr/liliMinimum 10+ years of relevant experience, ideally within pharma/biotech.br/liliAt least 5+ years of hands‑on experience in small molecule DP/FP development.br/liliProven experience managing Contract Manufacturing Organizations (CMOs).br/liliExperience across clinical and commercial manufacturing.br/liliProject management experience is an advantage.br/liliExperience with other modalities is a plus.br/li /ulbrKnowledge Skillsbrullibr/liliStrong understanding of cGMP and global regulatory guidelines (EMA, FDA, ICH).br/liliExpertise in solid dosage form development and manufacturing. xgiwjmb br/liliExcellent English communication skills (written and verbal).br/li /ulbrBenefitsbrullibr/liliCompetitive year salarybr/lili8.33% holiday allowancebr/liliA minimum of 30 vacation days for a healthy work‑life balancebr/liliExcellent pension plan to secure your futurebr/li /ulbr