Analytical Development Analyst

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Job description

Overview:
Work on the development, transfer and validation of robust analytical methods (sample preparation, chromatographic analysis, dissolution testing, etc ) to support tech transfer, stability testing and quality control testing of injectable drug products formulations and raw materials as well as physical-chemical testing of products under development and studies of stability. Write protocols, reports and work bulletins with test results obtained in the analysis performed.

Work on the sampling of packaging and raw materials and perform own administrative tasks to support R&D activities.

Responsibilities:
Work on the development, transfer and validation of robust analytical methods for the testing of pharmaceutical products and cleaning verification, according to Good Manufacturing Practices (cGMP) and ICH Q2 requirements.

Write analytical method development reports, and support validation, transfer protocols and reports generated in the laboratory, and evaluate the results of different tests to generate new proposals for future trials.

Perform analytical investigations and analytical problem solving, in support of formulation development activities validation and analytical transfer.

Work on the sampling of packaging and raw materials for all the R&D activities according to Good Manufacturing Practices (cGMP) and internal procedures.

Write and manage the planned deviations of packaging and raw materials for all the R&D activities under the supervision of the Analytical Development Scientist

Manage the SAP activities (stock, release under planned deviation, movements, etc.) of raw materials for all the R&D activities under the supervision of the Analytical Development Scientist.

Perform order request in SAP system of materials and services necessary for Analytical Development laboratory activities under the supervision of the Analytical Development Scientist.

Support in reagents and materials stock management of the Analytical Development laboratory.

Perform the analysis of raw materials according to the needs of the Analytical Development laboratory.

Write methods and Standard Operating Procedures under the supervision of the Analytical Development Scientist.

Provide analytical support to the team and other departments

Complete OOS and Deviations documentation assigned.

Collaborate during the transfer of robust analytical methods to QC labs.

Ensure good relationships and collaboration with all other teams in Formulation Development, QC, Operations, QA, etc.

Qualifications:
Education: MSc in Analytical chemistry or related scientific degree with strong chemistry content or Pharmaceutical degree with significant experience in such position.

Languages: Good level in spoken English and very good level in written communication is an asset.

Experience (years/area): Minimum 3-year experience as Analytical Development Scientist, with minimum 3-year experience in Liquid Chromatography (HPLC, UPLC being an asset) in the Pharmaceutical industry / GMP environment. Experience with characterization of parental depot formulations including expertise in USP Type IV dissolution apparatus is an asset.

Specific Knowledge: Strong knowledge in analytical instrumentation. Solid expertise in chromatography: LC, GC, SEC and good experience in MS. Knowledge of GMP regulation, ICH, FDA, USP and EP pharmacopeias.

Travels: Ability to travel domestic (occasional).

Personal skills: Proactive, creative with good problem solving skills. Demonstrated ability to communicate and effectively interact with cross functional teams and outside teams.

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