Senior Analytical Chemist I - Eurofins CDMO Alphora Inc.

Job Description

The Senior Analytical Chemist Level I is accountable to the Director, Analytical Services for all activities relating to performing either cGMP or non-GMP analytical development work. The scope of the responsibility includes performing analytical method development, validations, forced degradation studies, conducting stability testing or R&D support testing as well as preparing the appropriate protocols and reports. You are comfortable in a modern, state-of-the-art laboratory and are highly proficient with HPLC/UPLC, GC, IC, KF and various wet chemistry techniques. Proficiency with LCMS and/or GCMS are definite assets. The Senior Analytical Chemist Level I is also an active member of interdepartmental research teams and is able to independently plan and carry out investigational work.

Description of Major Job Responsibilities:

1. Reporting to the Analytical Chemist Team Leader or Analytical Manager, independently plans and executes analytical method development efforts by developing standard and complex raw material, in-process control, intermediate and API test methods and ensure that they provide adequate support of the specified limits.
2. Independently plans and executes investigational work, generating reports subject to regulatory review.
3. Researches and applies new technologies/methodologies.
4. Prepare method development updates for client review.
5. Author analytical test methods and specifications for cGMP use by either by QC or Analytical Development.
6. Conduct process development sample analyses.
7. Conduct peer review of critical non-GMP analyses of process development samples.
8. Plan and prepare analytical method validation protocols, carry out lab-work and prepare reports.
9. Plan and prepare stability protocols, carry out lab-work and prepare reports.
10. Plan and prepare forced degradation study protocols, carry out lab-work and prepare reports.
11. Perform standard qualifications testing.
12. Identify and support the write-up of OOS, OOT, OOC and deviation documents subject to regulatory review.
13. Work neatly to maintain the laboratory in an organized state.
14. Work in accordance with established GMP and safety requirements.

Qualifications

B.Sc. with 5-10 years of pharmaceutical experience or MSc/PhD with > 5 years of experience in related field. Experience in pharmaceutical analysis, development and validation. Excellent skills in technical writing and GMP documentation. Excellent problem-solving, planning and organizational skills coupled with a strong attention to detail. Assist in project planning and staff training. Strong communication skills.

Additional:

• Perform instrument calibration/performance verifications.
• Order laboratory supplies and chemicals as required.
• Perform additional duties as required.

COMMUNICATION AND CONTACTS:

• Within the Company Quality Assurance for documentation approval and corrections (analyses, protocols, reports and instrumentation IQ/OQ/PV).
• Active member of interdepartmental Process Research and Development teams for collaboration in analytical method and process development.
• Quality control for the transfer and troubleshooting of new test methods/specifications.
• Engineering for issues relating to facility support of instrumentation.

Additional Information

At Eurofins we offer excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.

Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.

As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca.

We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted. NO AGENCIES, CALLS OR EMAILS PLEASE.