Pharmaceutical Development Chemist

Vacancy details

General information

Reference

2025-2001  

Position description

Category

Scientific - Pharmaceutical Development

Job Title

Pharmaceutical Development Chemist

Job Summary

The Pharmaceutical Development Chemist is accountable to and interacts with the Pharmaceutical Development Manager. The Pharmaceutical Development Chemist supports all activities required to test, develop, optimize, scale-up and transfer formulations and their associated manufacturing processes, ensuring suitability for commercial production. In addition, the Pharmaceutical Development Chemist will support regulatory filing, commercial transfer and subsequent product launch and commercialization activities. The tasks and responsibilities listed above and below will apply to both internal and external projects.

Responsibilities

·         Provides leadership within the pharmaceutical development team, as well as across functional project tactical team.

·         Development of complex new formulations which includes but is not limited to characterization studies, forced degradation and compatibility assessments.

·         Supports the development of manufacturing processes ensuring scalability to commercial production.

·         Conducts experiments with regards to various types of primary packaging components.

·         Manufactures and tests pharmaceutical development lab batches which may include:

o    Weighs, mixes and blends raw materials to produce experimental trials and small-scale batches for solutions and semi-solid formulations.

o    Records observation on product and process characteristics during experimental trials and propose changes to improve compounding procedure based on observations.

o    Tests laboratory R&D samples as required.

o    Designs and conducts accelerated or long-term experiments to establish the stability of the developed formulation. 

o    Sets-up and cleans all equipment including mixers, containers, reaction vessels, and tanks.

·         Supports Analytical Chemists with analytical method development, transfer and optimization when required.

·         Authors the formulation/processing development protocol and report. Writes-up and signs off various documents such as compounding batch record and demo batch study protocol.

·         Assists in scale-up and technology transfer from pharmaceutical development batch scale to commercial process including gap analysis and pFMEA.

·         Assists with trouble shooting from process development/scale-up to production of stability batches.

·         Provides technical support to Production during manufacture of batches in Production.

·         Assists in the investigation of process deficiencies of existing formulations to determine the cause and recommends solutions for improvement.

·         Attends external customer project meetings and contributes to the technical discussion.

·         Providing technical oversight of production or development staff during demo batch execution, lab batch execution, or others studies, as required.

·         Follows GMP and regulatory requirements and ensures quality standards are met.

·         Follows and supports all safety guidelines and regulations.

·         Demonstrates the Company Mission, Vision and Values Statements, policies, and current standard business practices.

·         Performs other related duties as required.

Qualifications

· B.Sc. Degree in biochemistry, pharmacy, pharmaceutics, chemical engineering, or related area. Masters or Doctorate considered an asset.

· At least 4 years working experience in a pharmaceutical formulation laboratory.

· Exposure to High Pressure Liquid Chromatography sample testing is desired.

· Practical experience and/or theoretical knowledge is essential in pH, Osmolality, dose delivery and other chemistry and physical tests.

· Experience in formulation/packaging/process development of liquid dosage forms and combinations products.

· Exposure to parenteral peptides and biologics is considered an asset.

· Proficient understanding of regulatory requirements.

· Project management experience managing multiple projects simultaneously.

· Strong communication skills both written and verbal.

· Ability to work under minimal supervision.

· Proven analytical and problem-solving skills to resolve routine and non-routine problems.

· Experience working in a self- directed team environment.

· Proven time management skills with the ability to balance competing priorities in a deadline driven environment

 

What we offer
Excellent compensation/benefits package.
Bonus and reward programs
Discounted gym memberships
Programs supporting work life balance
Employee recognition program
Professional and personal development programs
social events and spirit days


We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.

In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.

Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.

Septodont Employee Referral – When submitting your application please select "Yes" to the referral question and provide the name of the Septodont employee that referred you in the "If yes, who?" field on your application.

 

Internal Job Posting Grade 9. The due date for internal applicants to apply for this role is February 19, 2025.

 

Contract type

Permanent

Position location

Job location

North America, Canada, Cambridge

Location

25 Woseley Court, N1R 6X3 Cambridge