Precirix is a clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing novel radiopharmaceuticals, using camelid single-domain antibody fragments labelled with radioisotopes. The company’s lead product, CAM-H2, is being evaluated in a Phase I/II trial targeting metastatic HER2-positive cancer. In addition, the company has several pre-clinical programs leveraging the technology strengths.
For the expansion of our CMC / manufacturing team, we are currently looking for an enthusiastic and experienced Clinical Supply Expert.
Purpose of the Position:
As Clinical Supply Expert you will manage development projects, contribute to processes such as forecasting, planning, ordering and distribution of key raw materials, components, nonclinical and patient doses for global (non-)clinical study programs.
We are looking for a candidate with a strong customer focus, proactivity, flexibility, teamwork abilities across functions, and pragmatic problem-solving skills. You have strong communication skills and can navigate smoothly in an international and diverse clinical supply environment. We are looking for a candidate with sense for organization and structure, knowledge in lean methods, digital mindset, focused on continuous improvement and optimization throughout the value chain. The candidate has a passion for people, products and processes.
- Coordination of all supply chain activities having a high focus on logistics.
- Responsible for translating key clinical development parameters and study designs into robust demand forecasts and operational outputs for study-level clinical supply planning.
- Internal CMC project management and coordination across departments.
- Collaboration with external CMO`s (Contract Manufacturing Organizations), vendors and third parties.
Skills, Expertise and Competences
Qualifications & Expertise
- Expected educational qualifications: MSc or BSc.
- Minimum 5 years’ experience in with planning, leading and follow up of development projects in the pharmaceutical industry.
- Experience with digital ordering platforms such as SAP or IRT systems is an advantage.
- Knowledge within (radio/bio) pharmaceuticals and/or clinical study management will be considered as an advantage.
- Experience with quality standards/guidance as (GMP/GDP/GCP).
- Experience with clinical studies distribution and logistics.
- Experience with forecast planning, and simulations software is an advantage.
Skills & Competences
- Ability to adhere to high ethical standards, GxP and legal and regulatory requirements.
- Excellent communication skills (verbal, written and interpersonal) and negotiation skills.
- Capable of working independently as well as in teams.
- Demonstrates strong analytical, problem-solving skills, eye for detail.
- Self-motivated with strong leadership abilities.
- Must be a result orientated multi-tasker, quick learner and able to work in a fast-changing environment.
- Fluent in English, any other language is an asset.
- Excellent computer skills.
- Continuously looking for opportunities to learn, build skills and share learning.
- Willingness to travel.
- An environment with nice colleagues that value a cooperative environment.
- Possibility for homeworking.
- Scale up company with a lot of opportunities and entrepreneurial atmosphere.
- Company that values the Clinical Supply field.
- Company with the mission to improve the life quality of patients.
- Team with different nationalities working together towards the same goal.
- Salary package according to your qualifications, hospitalization insurance, group insurance (3% of the gross wage fully paid by employer), costs proper to employer according to level, meal cheques, eco cheques, bonus.
Want to explore this opportunity? Mail us at firstname.lastname@example.org with a letter of motivation and your cv; and we will get in touch with you.