Jobid: 3195968790 (0.11)
Overview
In this role you will serve as the subject matter expert for DP/FP manufacturing of the small molecule portfolio, leading development, scale-up, validation and transfer. You will collaborate with CMOs to bring products from clinical development to commercial launch and help shape development strategies within the CMC team. You’ll tackle challenging manufacturing issues and design packaging for final products. This position offers the chance to influence regulatory-ready strategies and work across cross-functional teams in a mission-driven company focused on rare diseases.
Arbeidsvoorwaarden / Benefits
- Competitive annual salary
- 8.33% holiday allowance
- Minimum 30 vacation days
- Excellent pension plan
Verantwoordelijkheden
- Lead design and execution of advanced studies for development, scale-up, validation, and process transfer of small molecule DP/FP
- Drive primary and secondary packaging design and implementation
- Manage external CMOs for development, manufacturing, and validation of clinical and commercial batches
- Represent DP/FP expertise within cross-functional CMC teams and align with development goals
- Plan, prioritize, and deliver work to meet timelines and budgets
- Author and present scientific reports and technical documentation to stakeholders
- Ensure knowledge transfer and mentor junior scientists
- Support business development by assessing manufacturing implications
Belangrijkste vereisten
- PhD or MSc with relevant pharma/chemistry background
- 10+ years of relevant experience in pharma/biotech
- 5+ years hands-on in small molecule DP/FP development
- Proven CMOs management experience
- Experience across clinical and commercial manufacturing
- Project management experience is a plus
- Knowledge of cGMP and EMA/FDA/ICH regulatory guidelines
- Expertise in solid dosage form development and manufacturing
- Excellent written and verbal English communication skills
- Strong communication and collaboration
- Leadership and mentorship
- Problem-solving and troubleshooting mindset
- Small molecule DP/FP development
- Scale-up and process transfer
- Drug product validation
Deel deze vacature: