Formulations Development Scientist - North York, Canada - Apotex

Apotex

Verified Company

North York, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

About Apotex Inc.

Job Summary

The Associate Scientist, Formulations Development works under the direction of Senior members of the Formulations Development team to support the development and enhancement of pharmaceutical formulations, manufacturing processes and related packaging components.

This may include Solids and Liquids dosage forms, in addition to inhalations and nasal drug delivery product development.

Job Responsibilities

Provides first level technical support to experimental trials in order to evaluate changes in manufacturing and packaging processes.
Contributes to team efforts to investigate and support the resolution of formula and commercialized product and packaging components issues.

Under the guidance of Senior team members and in collaboration with multiple cross functional stakeholders contribute to the development of scientific reports to support NPD Projects.

Provides input and contribute to the preparation of RLD characterisation reports on inhalation Quality Target Product Profiles and identify Critical Quality Attributes.

Supports the preparation of Risk Assessment Reports as per Quality by Design (QbD) guidelines for NPD projects.

Works in close collaboration with cross functional teams and technical experts to write investigation reports related to stability/submission batches, deviations, excursions and/or packaging studies.

Responsibility for identifying and escalating issues of higher degree of complexity to Senior team members for review and analysis.

Responsibility for ongoing review of relevant scientific literature, attendance at appropriate trainings, seminars and presentations to maintain expertise in formulations and related areas.

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
Recognized post-secondary education in Pharmacy, Pharmaceutical Technology, or related Sciences. Mpharm (+) preferred.
Knowledge, Skills and Abilities
Working and theoretical knowledge of controlled released dosage forms, controlled substances, pharmaceutical dosage forms and manufacturing processes.
Knowledge of formulation development following QbD principles, formulation characterization, process development, and scale up of products.
Knowledge of GMP, GLP, Safety, FDA and TPD guidelines
Knowledge and understanding of interactions of excipients/APIs
Familiarity with inhalations formulations and device development is an asset
Strong verbal and written English communication skills
Excellent organization and report writing skills
Multi-tasking and project management skills
Experience
Minimum 4 years' experience related to Pharmaceutical manufacturing processes, equipment and Technologies.
Experience with Pharmaceutical Manufacturing equipment, troubleshooting and Technical transfer.
Experience using Microsoft Office (Word, Excel, Access, PowerPoint and Outlook)

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.