Associate, Analytical R&d

About Apotex Inc.

Job Summary

Under the supervision of the AR&D Group Leader, conducts the activities related to the development/optimization of analytical methods and specifications for pharmaceutical actives as part of new product development or product life cycle management activities.

Job Responsibilities
Under guidance, tests R&D samples using proper techniques and operational knowledge, including NMR, HPLC/UPLC, GC, UV, IR, ROI, KF, IC, Auto titration, and any other standard Pharmacopoeial test methodology.
Carries out work related to analytical method development, cleaning validation studies, and standard certification.
Reports all testing results and deviations encountered during testing. Utilizes basic analytical knowledge and experience in carrying out assigned investigation activities.
Properly documents analytical data and information in an accurate and organized manner. Self-reviews analytical data for accuracy and completeness.
Assists senior staff with analytical method development activities, as required.
Carries out stress studies on raw materials and finished products.
Promptly identifies and discusses problems related to instruments and methods of analysis with the Group Leader.
Assists analytical R&D staff to meet overall project deadlines.
Takes a leading role in troubleshooting of analytical methods.
Assists in documentation reviewing.
Trains junior staff members for proper operation of equipment and related software, as well as, for proper documentation of daily analytical work.
Validates/calibrates instruments, as directed. Properly documents instrument logbooks for routine maintenance, repairs, calibration, and validation.
Identifies the need for chemicals, gases, standards, glassware, and other supplies.
Maintains an organized and safe laboratory environment, including instruments, and glassware
Presents the technical data in an accurate and organized manner, both verbally and written.
Develops ability to critically assess results for accuracy and precision; suggests or determines critical parameters causing poor or inconsistent results.
Assists senior staff in training junior staff members.
Works in a safe manner collaborating as a team member to achieve all outcomes.

**Demonstrate Behaviours that exhibit our organizational Values**: Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other relevant duties as assigned.

Job Requirements
Education
Minimum CET degree (or equivalent),
Preference for M.Sc. in or B.Sc. in Chemistry.
Knowledge, Skills and Abilities
Knowledge and experience operating instruments such as NMR, HPLC/UPLC, GC, IC, UV, IR, KF, Potentiometric Titrator etc.
Knowledge of and experience with standard wet chemistry techniques routinely used in an analytical lab setting as applied in the pharmaceutical field.
Familiar with cGMP principles.
Familiar with USP, BP, EP, and ICH guidelines and procedures.
Experience in Analytical Method Development and Validation is an asset.
The ability to work as a member of a team.
Ability to adapt to frequent changes in priorities and schedules.
The willingness to upgrade knowledge/education on an on-going basis.
Possesses sound troubleshooting skills and proficiency with key laboratory instrumentation.
Possesses/develops the ability to adapt to frequent changes in priorities and schedulesGood communication skills, both verbal and written.
Knowledge of Windows, Microsoft Word, Excel, Empower and/or Chemstation/Chemstore software, LabX, Chromeleon.
Experience
2 years of experience in a related field with a MSc in Chemistry; or
4 years of experience in a related field with a B.Sc. in Chemistry; or
7 years of experience in a closely related field with CET degree (or equivalent)

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.