This job posting has expired.

Here are some similar positions.

Specialist, Analytical Development

May 20 2020
Industries Pharmaceutical, Biotechnology
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Quality assurance and control, Validation, Chemistry, Medical and pharmaceutical information, Laboratory, Research and development, Health, Safety, Environment
Montreal, QC

Description

Tasks & responsibilities:

. • Develop and troubleshoot methods using various equipment (LC, GC, Dissolution, Laser Diffraction, etc) and detectors (UV, Light Scattering, MS, FID, etc.);
• Actively participate in resolution of Clarifaxes and/or Deficiency Letters ;
• Interact with external partners to resolve challenges;
• Deals with the specifications related activities;
• Follows up on the above activities, communicates and ensures that timelines are respected with the appropriate quality.
• Provide technical support to the Analytical Services and Pharmaceutical Development teams with respect to the development of bio-relevant dissolution methods, interpretation of analytical results, problem solving and various scientific initiatives.
• Participate in the development of novel products.

Skills, Knowledge and Abilities : 

  • Handles workload with precision and meets prescribed deadlines;
  • Works well under stress;
  • Accurate; Well organized;
  • Bilingual French/English;
  • Resourceful; Autonomous;
  • Positive attitude;
  • Detail oriented; Meticulous.
  • Knowledge of Empower, LIMS, Microsoft
  • Office; Knowledge of Agilent chromatographic instruments (or other)I ICP-OES or ICP-MS, GC, GC-MS, LC-MS and technical knowledge on instruments for material characterisation ( NIR, FTIR, XRD, RAMAN, PSD by Malvern, Morphology
  • Develops reproducible and appropriate analytical methods;
  • Act as team leader for a group of analysts by directing their activities and providing guidance.
  • Performs analytical troubleshooting in collaboration with internal and external stakeholders;
  • Write procedures and investigative reports;
    Interpret and apply various international regulations; 
  • In collaboration with researchers from pharmaceutical development group and specifications and DMF specialists, the incumbent will participate in the establishment of limits based on all the results..
  • Work in concert with our external partners with respect to analytical methods and results used by PMS; 
  • Participate in the evaluation of analysts;
    Provide support to other departments (R&D; Commercial) to resolve issues (out of specifications, etc); 
  • Act as a reference person for the operation and use of instruments (U / HPLC, GC, Dissolution, MS, Particle Size, etc);

Education:

Bachelor's or a Master degree in Chemistry or Biochemistry;

Experience:

Minimum of four (4) years experience in a similar position with a Bachelor's degree;
Minimum of two (2) year experience with a Master degree
Good knowledge of the pharmaceutical industry and GLP;

Jobs.ca network

#