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Process Development ScientistNWRPros • Victoria, BC, United States
Process Development Scientist

Process Development Scientist

NWRPros • Victoria, BC, United States
1 day ago
Salary
CA$140,000.00 yearly
Job type
  • Full-time
Job description
Job title: Process Development Scientist
Reporting to: Manufacturing & Supply Management
Location: Vancouver, BC: (Hybrid)
About Us:
Our client is an exciting clinical-stage biotechnology company focused on developing locally delivered, extended-release products that have the potential to address therapeutic areas with high unmet medical need. The Company has developed a proprietary technology designed to facilitate targeted drug delivery of both existing and novel drugs. The technology is designed to support an extended duration of effect and delivery of drugs in a hyper-localized fashion, targeting only the tissues that physicians want to treat.
The Company believes the potential for fewer adverse events may be achieved through the precision targeting and the stable and flat delivery of the active ingredient when using this proprietary technology, versus the peaks and troughs seen with more traditional drug delivery methods. The precision of the platform has the potential to augment and transform existing FDA-approved drugs to improve their safety, tolerability, efficacy and duration of effect. The potential uses in therapeutic areas may go beyond initial targets and also to be applicable in oncology, infectious disease and other critical disease areas.
The current target application is currently in a Phase 1b/2 trial. Potential pipeline indications include candidates for other indications, each designed to improve on the activity and tolerability of currently approved drugs.
Our client is looking for people who would like to work for a fast-paced, growing company that fosters a creative spirit and integrated teamwork and who are eligible to work in Canada.
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.

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Process Development Scientist • Victoria, BC, United States

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