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Assistant Scientist, Analytical Development - PDS

 

Contract Pharmaceuticals Limited is a contract manufacturer and packager of prescription and over the counter pharmaceutical products. We are dedicated to providing comprehensive and innovative outsourcing services that exceed the uncompromising demands of the global pharmaceutical industry.

Purpose:
Product Development group supports all activities required to develop, optimize and scale-up a stable semi-solid (cream, lotion, ointment, gel)/liquid (topical, oral, sub-lingual, nasal spray) formulation to make it suitable for commercial production.  Assistant Scientist within this group is responsible for the analytical method development, method validation, method transfer to support formulation development and product commercialization.  The Assistant Scientist assists the Manager, Analytical Development - PDS to maintain laboratory operation and ensure that all work is performed in accordance with the applicable SOP's, cGMP's and GLP's.

SPECIFIC RESPONSIBILITIES:

- Responsible for promoting and maintaining safe and healthy working conditions in his/her assigned work area; instructs and enforces compliance with established safe work practices and procedures; ensures assigned trainees receive appropriate training and information necessary to conduct their activities in a safe and healthy manner.
- Promotes and exemplifies the CPL Culture, ensuring the delivery of an exceptional customer experience through demonstrating CPL's core values.
- Performing analytical method development, method validation, method transfer and sample testing.
- Performing stability testing in accordance with ICH or other regulatory guidelines.
- Preparing and implementing stability protocol and scheduling.  Compiling stability testing reports for submission to the customer and/or regulatory agencies.
- Supporting analytical laboratory operations and assist product development, optimization, submission to appropriate regulatory agencies, and technical transfer for scale-up, validation and manufacturing within scheduled timeframes.
- Developing and fostering an environment that value troubleshooting skills and root cause analysis expertise.
- Ensures that all work is performed in compliance with the required applicable SOP's, cGMP, GLP and established Safe Work Practices (SWP).
- Support Product Development Team to ensure the timely completion of the project.
- Keeping current on emerging analytical technologies, and providing technical resources to support Analytical Development strategies.
- Responsible for the efficient utilization of resources and supplies to reduce waste and achieve cost containment and lean objectives.
- Participates in the evaluation of prospective analytical methods, literature, procedures and protocols to determine technical feasibility and project scope.
- Participate development of scientifically and technically sound analytical development strategies.
- Other duties as assigned.

QUALIFICATIONS:

 

- B.Sc. or M.S. in pharmaceutical sciences or Life Sciences field, with 1 - 3 years of related experience in research and development area of pharmaceutical industry.
- Knowledge of analytical method development, method validation and method transfer.
- Working knowledge and applicaiton of GMP's/GLP's principles, ICH guidelines and compendial methods, in addition to other related and relevant guidelines and regulations.
- Demonstrated competencies in CPL's core values of Integrity, Fairness, Trust and Respect.
- Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
- Strong verbal and written English communication skills.
- Ability to use computers with familiarity with MS Office.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

- Lab Environment.

 

CPL is an equal opportunity employer committed to diversity and inclusion.  We welcome applications from all qualified individuals.  CPL is committed to accommodating persons with disabilities.  If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at hr@cplltd.com.

Interested applicants should submit a cover letter and resume to the contact information below. If submitting your application via e-mail, please indicate the job title in the subject line.

Contract Pharmaceuticals Limited Canada
Human Resources
F) (905)821-0386
E) hr@cplltd.com
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We thank all applicants for their expression of interest; however only those selected for an interview will be contacted. No phone calls or agencies please.