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

ph3About the Role /h3 pAs 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. /p pWorking 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. /p h3Key Responsibilities /h3 pExecution Leadership /p ul liIndependently lead the design and execution of advanced studies for development, scale‑up, validation, and process transfer of small molecule drug products. /li liDrive the design and implementation of primary and secondary packaging solutions. /li liManage external CMOs for development, manufacturing, and validation of clinical and commercial batches. /li liRepresent DP/FP expertise within cross‑functional CMC teams, aligning strategies with overall development goals. /li liPlan, prioritize, and deliver work to meet timelines and budgets. /li liAuthor and present scientific reports, technical documentation, and updates to internal and external stakeholders. /li liEnsure knowledge transfer across teams and mentor junior scientists. /li liSupport business development activities by assessing manufacturing implications. /li /ul pRegulatory Compliance Quality /p ul liOwn and manage complex deviations, CAPAs, and change controls, ensuring timely and compliant resolution. /li liTroubleshoot manufacturing challenges and deliver innovative, science‑driven solutions. /li liStay current on regulatory requirements (EMA, FDA, ICH) and emerging industry trends. /li liWrite and review development reports, validation documentation, and CMC dossier sections (IMPD, IND, NDA/MAA). /li liAct as SME in interactions with regulatory authorities, addressing complex questions. /li /ul h3Your Profile /h3 h3Education /h3 ul liPhD or MSc in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline. /li /ul h3Experience /h3 ul liMinimum 10+ years of relevant experience, ideally within pharma/biotech. /li liAt least 5+ years of hands‑on experience in small molecule DP/FP development. /li liProven experience managing Contract Manufacturing Organizations (CMOs). /li liExperience across clinical and commercial manufacturing. /li liProject management experience is an advantage. /li liExperience with other modalities is a plus. /li /ul h3Knowledge Skills /h3 ul liStrong understanding of cGMP and global regulatory guidelines (EMA, FDA, ICH). /li liExpertise in solid dosage form development and manufacturing. /li liExcellent English communication skills (written and verbal). /li /ul h3Benefits /h3 ul liCompetitive year salary /li li8.33% holiday allowance /li liA minimum of 30 vacation days for a healthy work‑life balance /li liExcellent pension plan to secure your future /li /ul /p #J-18808-Ljbffr