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Scientist - Technical Writer, Analytical Development

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: The Product Development group supports all activities required to develop, optimize and scale-up a stable semi-solid (cream, lotion, ointment, gel) / liquid (topical, oral, sublingual, nasal spray) formulation to make it suitable for commercial production.  The position within this group is responsible for the analytical method development, method validation, method transfer to support formulation development and product commercialization.  He/She is also responsible to generate documents used in support of cGMP and non GMP activities in analytical development.  He/She assists the Manager, Analytical Development to maintain laboratory operation and ensure that all work is performed in accordance with the applicable SOP's, cGMP's, and GLPs.

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.
- Generate or assist in the generation of documents used in cGMP and non GMP activities in analytical development.
- Providing recommendations on suitability of analytical methodologies for submission to the customer and/or regulatory agencies.
- Ensuring that analytical laboratory operations are coordinated to support product development, optimization, submission to appropriate regulatory agencies, and technical transfer for scale-up, validation and manufacturing within scheduled time frames.
- Developing and fostering an environment that value troubleshooting skills and root cause analysis expertise.  Assisting in the technical training of junior analytical staff.
- Ensures that all work is performed in compliance with the required applicable SOP's, cGMP, GLP and established Safe Work Practices (SWP).
- Coordinates timelines and analytical resources requirements with 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 fo resources and supplies to reduce waste and achieve cost containment and lean objectives.
- Evaluates prospective analytical method, literature, procedures and protocols to determine technical feasibility and project scope.
- Independently develops scientifically and technically sound analytical development strategies.

QUALIFICATIONS:

- M.S. or Ph.D. in pharmaceutical sciences or Life Sciences fields, with minimal 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 application of GMPs/GMPs principles, ICH guidelines and compendial methods, in addition to other related and relevant guidelines and regulations.
- Proficient in using various types of computer software, MS Office, Trackwise and Minitab skills are an asset.
- Demonstrated competencies in CPL's core values of integrity, Respect, Trust and Fairness.
- Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
- Strong verbal and written English communication skills.

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.