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Jubilant DraxImage inc.: Analytical Validation Specialist (R&D)

Jubilant DraxImage inc.

This is a Full-time position in Montreal, QC posted June 4, 2021.

Jubilant DraxImage, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for an Analytical Validation Specialist (R& D) position to join our growing team What can we offer?

A culture that values opportunity for professional growth and development,highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant DraxImage Inc.

is a rapidly growing company with offices in Kirkland, QC and Yardley, PA.

A global leader in the development of radiopharmaceuticals and state-of-the-art technologies, we are continuously seeking high caliber professionals to join our team.

Jubilant DraxImage is a proud member of the Jubilant Pharma family.

For more information, visit www.Draximage.Com We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc and all our subsidiaries proudly embraces diversity in our workforce.

Our goal is to have a workforce as diverse as the patients and clients we serve.

We have an inclusive environment where our employees can thrive and where our differences are welcomed.

By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary Responsible for verifying the analytical development report, drafting validation protocols, executing validation protocols, writing validation reports, writing technical transfer protocols, training QC and executing transfer protocols for pipeline analytical methods.

Participating in annual review of legacy products and revalidating them as necessary.

Ensuring the calibration and compliance of all GMP qualified equipment in the R& D analytical lab.

Involved in the analysis of various R& D samples.

Responsabilities Principales responsabilitiés / Main responsibilities: Work with development group to propose new specifications and analytical methods for pipeline projects Develop new analytical methods and test compendial methods for new pipeline projects Conduct pre-validation studies on analytical methods, including robustness testing Test products in development studies (pre-submission/validation batches) Write method development reports Review validation protocols and reports Troubleshoot analytical methods for current products Active participant in life cycle management of analytical methods R& D sample analysis (preparation and analysis) Qualifications-expérience requise / Qualifications required experience: Minimum 2 years experience in Pharmaceutical manufacturing (GMP environment) Analtyical method developoment experience Radiochemistry experience is desirable Experience with HPLC/GC validation Written and spoken English/French Expereience on various analytical instrumentation (FTIR/UV/KF/AA/etc) Minimun of BSc.

or DEC in Chemical eng., Chemistry or Biochemistry Technical requirements Excellent communication skills in English and French Excellent written skills in English and in French.

Ability to write scientific reports and protocolsWorking and theoretical knowledge of analytical methods such as HPLC, GC, Atomic Absorption Spectroscopy, Mass Spectrometry, UV, titration Required Competencies: Thorough knowledge of IHC, FDA and European guidelines for drug development Thorough knowledge of cGMPs Practical and theoretical knowledge of analytical method validation Exhibits an organized and focused approach to work Exhibits initiative and can work effectively without supervision