Senior Expert - Device Project Leader - Combination Product Portfolio (80-100%)

ph3Job Description Summary /h3pSalary Range: CHF93,800.00 - CHF174,200.00. Band Level 4. Location: Basel, Switzerland; Schaftenau, Austria. Hybrid work options. /ph3Role Overview /h3pSenior Expert – Device Project Leader will be a vital part of the Portfolio Customer Center within the Global Device and Packaging Development (GDPD) team based in Basel or Schaftenau. The primary responsibility is to guide and manage cross‑functional project teams both within and outside of GDPD, representing GDPD in CMC sub‑teams, leading discussions, securing endorsement for project strategy and changes with a focus on Cell Gene Therapy (C®) and Radioligand Therapy (RLT) projects. /ph3Responsibilities /h3ulliRepresent GDPD in CMC sub‑teams, leading device‑related discussions and securing endorsement for project strategy or changes. /liliLead cross‑functional project teams, acting as a single point of contact for all device and packaging related issues. /liliPlan, manage and control project resources, schedules and budgets. /liliAssess and negotiate internal and external resource needs on an ongoing basis. /liliEstablish and maintain high‑quality documentation up to Design History File for combination products and LCM projects until transfer to manufacturing sites. /liliEnsure compliance with internal process requirements and current regulations, including Design Control, CMC, FDA combination product regulations and ISO requirements. /liliContribute to the improvement of process and delivery technology approaches. /liliEvaluate suitable device technology to support different project phases. /liliSupport internal and external audits on packaging and medical device related matters. /liliAssist teams in regulatory dossier preparation, including documents for medical device/combination product registration and in responding to health authority queries. /li /ulh3Qualifications /h3ulliMaster or PhD (preferred) in natural science, engineering, pharmaceutical field or equivalent. /liliMinimum 2–4 years of experience in the pharmaceutical industry, preferably with exposure to C® and RLT and to drug‑device combination product technical development including technical operations. /liliAbility to work and lead a cross‑functional team in a matrix environment. /liliProven knowledge and track record in project and program planning and execution. /liliUnderstanding and awareness of regulatory guidelines for drug‑device combination products, including relevant ISOs and current good manufacturing practices (cGMP). /liliCollaborative spirit, self‑driven attitude, high learning agility, good listening skills, strategic thinker. /liliFluent in English (oral and written). German is beneficial. /li /ulh3Benefits Rewards /h3pThe base salary range for the role is CHF 93,800–CHF 174,200, determined based on gender‑neutral objectives such as relevant skills, competencies and experience in accordance with Novartis pay setting policy. A performance‑based bonus may be awarded depending on certain performance parameters. Additional benefits include competitive insurance and retirement plans, wellbeing resources, global recognition programs, flexible and hybrid working options where possible, and a minimum of 14 weeks paid parental leave. /ph3Accessibility and Accommodation /h3pNovartis is committed to working with and providing reasonable accommodation to all individuals. If a medical condition or disability requires accommodation for any part of the recruitment process or to receive more detailed information about the essential functions of a position, please email and include the job requisition number in your message. /p /p #J-18808-Ljbffr