Senior Analytical Chemist I

Eurofins CDMO Alphora is looking for Senior Analytical Chemist to join our dynamic and growing team!

WHO ARE WE?

Eurofins CDMO Alphora Inc. develops and manufactures new therapeutics to improve the lives and health of patients. Eurofins CDMO Alphora provides contract research & development services to global pharmaceutical and biotech companies, developing their processes and manufacturing their bulk drug substances (Active Pharmaceutical Ingredients -“API’s”) as well as finished dosage products (tablets, capsules, suspensions) for supply to clinical trials and commercial requirements. Eurofins CDMO Alphora provides a rich and technologically challenging environment with a continuing flow of interesting projects. Our employees work in close concert with clients throughout the development process to achieve their program objectives. Eurofins CDMO Alphora Inc. is growing its state-of-the-art organization, with continued investments in modern facilities, equipment, and instrumentation while providing a rich environment for employees to develop their technical skills and careers paths.

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.

KEY DUTIES AND RESPONSIBILITIES:

• 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.
• Independently plans and executes investigational work, generating reports subject to regulatory review.
• Researches and applies new technologies / methodologies.
• Prepare method development updates for client review.
• Author analytical test methods and specifications for cGMP use by either by QC or Analytical Development.
• Conduct process development sample analyses.
• Conduct peer review of critical non-GMP analyses of process development samples.
• Plan and prepare analytical method validation protocols, carry out lab-work and prepare reports.
• Plan and prepare stability protocols, carry out lab-work and prepare reports.
• Plan and prepare forced degradation study protocols, carry out lab-work and prepare reports.
• Identify and support the write-up of OOS, OOT, OOC and deviation documents subject to regulatory review.
• Work neatly to maintain the laboratory in an organized state.
• Work in accordance with established GMP and safety requirements.

Qualifications

The ideal candidate will:

• 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.

Additional:

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

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.

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.