32384 R and D - Project Manager

18-9-2018 beerse
bedrijfsprofiel

This company is an international player that is committed to researching and developing new medical products. Do you want to help people live longer, healthier and happier? Mail your resume with motivation letter to lotte.coenen@cx.ausy.be.

For additional information: 03 200 28 01

jobomschrijving

Do you have a fascination for R and D? Strong project management skills? Then you are the one I am looking for!

- Provide CMC (Chemical manufacturing Control) Team Support and represent “PDMS PM” at the PMT Team.
- Translates the CMC strategy into realistic and executable CMC deliverables with clear assumptions based on CMC & Commercial input
- Supports risk management process, specifically identification and development of mitigation strategies with CMC team & PMT
- Works out scenarios to support decision making in line with CMC, JSC and CDT (Compound Development Team) strategy
- Manages the CMC end-to-end process from pre-NME (New Molecular entity) through launch
- Proactively plans and manages the cross-functional project deliverables that support the CMC development and Commercial Launch: o Works in close collaboration with the CMC Leader, SI’s, JSC New Product Team (NPT) and Commercial Lead
o Active follow-up on the progression of all CMC activities required to successfully launch product
o Monitors CMC driven key milestones, decision points and critical path activities

jouw aanbod

Qualifications
- A minimum B.S. degree. a MS, MBA, PharmD, PhD degree in a pharmaceutical-related, life sciences, or business subject.
- Professional project management certification (eg, PMP) or degree is a plus

Experience
- 7+ years of industry/business experience, depending on level, including at least 4-6 years in the pharmaceutical industry.
- Experience with CMC development and is a must and supervisory experience is a plus.
- Experience required in areas such as manufacturing, active pharmaceutical ingredient, drug product development, CMC regulatory, analytical development, etc.
- A working knowledge of drug development is required. Experience in developing a health authority dossier is a plus.

wat bieden wij?

Ausy is a separate division of the Randstad Group, which exclusively focuses on highly qualified specialists in Life Sciences, ICT, finance, engineering, sales & marketing and HR.

A fascination for the medical world? Do you want to contribute to the development and production of life-saving resources? Then you have come to the right place at our Life Sciences department! We would like to offer you access to our top companies, place your development at the center and offer tailor-made advice.

overzicht
functie
kwaliteit en milieuspecialist (m/v)
jobtype
voltijds, freelance
contracttype
onmiddellijke vaste indienstname
referentie
CXRSP-72881
contact informatie
Lotte Coenen
Lotte.Coenen@cx.ausy.be +32 2 472 63 98
+32 2 472 63 98