Cando pharmatech Canada hiring Analytical Development Scientist

Candoo Pharmatech is currently hiring an Analytical Development Scientist

Job Summary:

Develop and conduct analytical work to support NDA/ 505b(2)/ANDA product development, facilitate “First to file” submissions and ensure that project timelines are met and aligned with the overall objectives of the company.

Plan and lead the analytical method development/ validation, impurity identification and quantitation, reference standard qualification, dissolution test, technology transfer, instrument qualification and quality control activities.

Provides CMC and technical expertise of analytical development for drug/excipient characterization, release, stability testing, regulatory submissions and patent preparation.

Collaborate with the Formulation Development, QA and Manufacturing teams to efficiently evaluate, select, and manage contract service providers; scale-up and technology transfer; design validation strategies.

Authorize and review analytical development documentations including analytical methods, validation protocols, specifications, reports and SOPS. Support the creation, maintenance and improvement of company’s Quality Systems.

Ensure that the analytical GMP work is conducted in compliance with applicable SOP’s, Regulations, and applicable safety procedures.

Job Requirements:

• MSc or PhD in pharmaceutical science, analytical chemistry, chemistry or related disciplines.

Minimum 5 years of experience in analytical R&D / quality control within pharmaceutical R&D function for PhD candidate and 7 years of experience for MSc candidate with a trackable record. GMP working experience is preferred.

Expertise in analytical method development/ optimization/validation (drug/excipient characterization, Assay, Related substance, Dissolution), de formulation, dissolution, stability design and data trending. Good knowledge and experience in different analytical instrument (HPLC, GC, IC, LC-MS, DSC, TLC, UV, KF….).

Demonstrated experience in setting up analytical laboratory.

• Excellent understanding of FDA, ICH guidelines and cGMP as well as drug product development process

Application process : Interested candidates can forward their CVs and/or resumes to

Address : 6800 Kitimat Rd Unit 1, Mississauga, ON L5N 5M1, Canada

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