ANALYTICAL DEVELOPMENT SUPERVISOR (M/F) - Minakem - Louvain-la-Neuve

ADS/1020/RECHLLN

R&D

Full-Time

Belgium (Louvain-la-Neuve)

Minakem High Potent with its site at Louvain-La- Neuve , Belgium is developing and producing highly
potent APIs and controlled substances according to cGMP and currently has two opened positions for :

Analytical Development Supervisor (M/F)

JOB DESCRIPTION

Develop state-of-the-art analytical methods for raw materials, intermediates and active pharmaceutical ingredients (APIs). Offer analytical support to process development as well as quality control laboratories and production department. Provide analytical expertise for new custom synthesis projects and for internal generic projects.

External contact is required with customers for analytical transfers and project information exchange as well as with contracting laboratories to which some analytical work (analytical method validations or investigations…) are outsourced.

DETAILS SCOPE OF THE POSITION

Review technical packages, understand scope, deliverables and constraints, compilation of milestone proposals for analytical development work on custom manufacturing and generic projects. Plan, coordinate and deliver QUOTIF (quality on time in full) all analytical development activities and compile key performance indicators (KPIs) on a regular basis. Support internal departments (Process development, Production, Quality Control, Quality Assurance, Regulatory Affairs, Safety, Health, Environment) and customers as required. Manage outsourced analytical activities. Lead and coach analytical development team members and ensure that they are properly trained and that they further develop their know-how. Establish procedures for analytical development and ensure safe operations within the laboratory. Ensure appropriate level of GMP (analytical method validation) is applied depending on the clinical phase of the project. Compile and review analytical development reports and submit for approval. Compile analytical transfer protocols and reports as well as stability protocols and reports and submit for approval. Periodically review analytical methods of commercial products and ensure they are updated to state-of-the-art methods. Monitor analytical instrument park and ensure it is properly serviced and in required state of compliance. Represent analytical development department in audits and implement appropriate corrective and preventive actions (CAPAs) in response to findings in a timely manner.Vous êtes bachelier en chimie et vous justifiez d’une expérience pratique en synthèse organique.

PROFILE

• University degree in Analytical Chemistry (Ph.D., Master), good organic chemistry knowledge will be appreciated.
• Excellent hands-on experience on analytical method development and cGMP rules (ICH guidelines)
• Good knowledge of analytical techniques (HPLC, GC, mass spectroscopy, titration…).
• Languages: fluent in English and French, any other languages will be a plus.
• Proficient use of common IT tools (Word, Excel , PowerPoint)
• Strong technical and interpersonal skills. Team spirit and highly developed customer-centric approach
• Creativity and flexibility