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 Job #02680 Email this job to a friend
About our client
Our client is a rapidly growing pharmaceutical company headquartered in Montreal that is focused on the manufacturing and distribution of various generic brand therapeutics. The company has some of the strongest financial indicators in the industry, an experienced management team, and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members.
Position Location
Team Leader, Formulation Development Montreal, Quebec
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Oversee the development and pilot-plant scale-up of novel and generic formulations in the areas of solid, oral, immediate, and modified release dosage forms
2) Guide a small team of research assistants/scientists and coordinate with the pilot plant, warehouse, and analytical groups
3) Supervise a small team of research assistants, research scientists or senior scientists towards the development and technology transfer of oral dosage forms for NDS/ANDS submission
4) Execute the development work on a new project or ongoing project
5) Review and coordinate with the Analytical Department for testing results
6) Recommend changes or improvements to the manufacturing or formulation process
7) Present and report to the senior management about the progress of the projects
8) Track development activities of on-going projects and achieve development targets with respect to timelines and cost allocations
9) Ensure that all activities are performed in accordance with corporate SOPs, guidelines, and safety standards
Requirements
1) Doctorate/Master's degree in Science (Biochemistry, Chemistry, Pharmaceutical Sciences or Pharmaceutical Technology)
2) 5 – 10 years of experience in the development of solid, oral, immediate, and modified release dosage forms
3) 1 – 2 years of supervisory experience with a small team
4) Experience in the generic pharmaceutical industry
5) Experience as a Scientist along with hands-on experience in formulation development and supervisory skills
6) In-depth knowledge of formulation development steps and procedures
7) Excellent knowledge of regulatory affairs and guidelines for Canadian, American, and European submissions
8) Superb knowledge of the pharmaceutical manufacturing process, excipients, and GMP principles
9) Good knowledge of evaluating patents and literature prior arts
10) Ability to work under challenging timelines
11) Good observational and innovative skills
12) Knowledge of Microsoft Word and Excel
13) Good communication skills (English and French)

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