CMC Project Manager

Brussel  ‐ Onsite
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Description

Mission Description Project Manager (Corporate Analytical Sciences)
Within the framework of a NCE (New Chemical Element) project, our client is looking for a project manager in analytical CMC to execute the following tasks:
"Support Analytical Product Owner in analytical methods portfolio maintenance:
- Publishing and updates of analytical methods and associated validation according to our client requirements, Change control management according to sop, Change control follow-up with QC internal and CLO.
"Support Analytical Product Owner in specifications portfolio maintenance:
- Each specific NCE project consists of different products (drug substance (API) and various drug products injectable solutions, syrups, tablets). Each product has its own specifications (method, dosage).. Publishing and updates of specifications according to our client requirements. Change control management according to sop, Change control follow-up with QC internal and CLO.
"Writing monographs
- The Project Manager will have to be able write official analytical methods for submission to the USP and European Pharmacopoeia. He will also need to interact with USP and Eur. Pharmacopoeia
"Stability oversight for products (Support Analytical Product Owner in stability portfolio management)
- Capacity to review and publish stability reports and to consolidate stability portfolio within our client organization. Follow-up with requested analytical information required for stability demands.
"Method repatriation
- Support Analytical Product Owner in mapping the QC Testing Network of commercial products by collecting all analytical related information and documents (QC testing sites, external QC testing sites, methods, specifications, validation reports, &).
oGlobal methods:
- Currently there are several different manufacturing sites (MS) with their own QC and several external laboratories where one or several analytical methods specific for this project were developed (sometimes for the same product). The objective is to collect all of these analytical methods and to reduce them to one single reference method to be used for all MS.
oGlobal specifications:
- The specific NCE project consists of different products (drug substance, injectable solutions, syrups, tablets). Each product has its own specifications (method, dosage). Each MS or Lab needs to send these specifications to the project manager. For some of the products, the project manager will either write an unique specification document from existing specifications that could be applicable in each MS or lab. For specifications that are possibly not available he will have to write new specifications from scratch.
Key Skills and requirements:
"Demonstrated capacity for managing a project autonomously: will need to manage over 100 documents by a certain deadline; will need to organize himself and prioritize; different projects to manage (different QCs)
"Key technical backgrounds: small-molecule chromatography (HPLC/GC) and detection techniques (UV/Vis, MS); dissolution techniques - EU, US and JP regulations - USP, EP, and JP pharmacopeias.
"Number of years of experience: Min. 5 years in CMC (not only lab experience)
"Experienced in Analytical Development for API (active pharmaceutical ingredient), DS or DP in a Pharmaceutical company
"Degree in analytical chemistry (min. Master)
"Language skills:
oFrench: 4/5 oral and written
oEnglish: 4/5 oral and written
"Detailed understanding of regulatory and GMP quality constraints
Start date
n.a
From
Harvey Nash BE
Published at
05.11.2015
Project ID:
1014240
Contract type
Freelance
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