Job title: Process Development Scientist
Reporting to: Manufacturing & Supply Management
Location: Vancouver, BC: (Hybrid)
Role Summary The Process Development Scientist will be responsible for developing and overseeing manufacturing processes for formulations at our contract manufacturing sites, including responsibilities for process scale up and optimization.
Reports to: Director, CMC Key Responsibilities - Oversee process scale up and optimization activities at our contract manufacturing sites for later stage clinical products and provide technical direction as required.
- Actively participate in production troubleshooting at all scales and be a "person-in-plant".
- Manage CDMO interactions and technical communications.
- Oversee that all manufacturing processes meet cGMP requirements for both US and EU.
- Identify and procure equipment required for scale-up and optimization operations, both in house and at CDMOs.
- Perform physical characterization of samples as required. Methods may include, optical microscopy, SEM, NMR, thermal analysis, rheology
- Effectively communicate, in written and verbal form, any interpreted research findings.
- Support writing of scientific and production reports, and the appropriate sections of regulatory filings including an IND or IMPD.
- Assist with CMC group operations as requested.
Requirements - Minimum of 8-10 years' experience in the pharmaceutical industry.
- PhD in chemistry, biochemistry, or pharmaceutical sciences. Candidates with MSc or BSc and considerable industry experience may be considered.
- Experience with recrystallization, wet milling and sieving required to provide technical direction when needed.
- Experience with GMP compliance in US and EU mandatory.
- Excellent verbal and written communication skills.
- Must have the ability to multi-task in a dynamic environment and work well within a team.
- A life-long learner mind set.
- A critical thinker.
Salary Range: $120,000 to $140,000 CAD depending on education and relevant experience.
