FSP Associate Research Scientist: QC Strategy & Analytical Sciences
$90,000–$110,000 year
On-siteNew Brunswick, Canada
Job Summary
Manage external project activities for Quality Control Strategy & Analytical Science functions by drafting Scope of Work documents, facilitating progress meetings with Contract Testing Labs, and leading project close-out processes. Establish a Single Point of Contact model with strategic partners, coordinate project work, track metrics, and ensure CTLs adhere to applicable processes, SOPs, and Quality Agreements. Liaise between technical teams, compliance, and external vendors to review project needs, estimate resources, and facilitate the transition of external work to internal streams. Drive process efficiencies and maintain required training in GMPs, safety, and departmental guidelines while supporting the advancement of the growing clinical research portfolio.
Required Qualifications
- Bachelor's degree in relevant life sciences program field
- 6-8 years of relevant experience within the pharmaceutical industry
- hands on experience in analytical chemistry with a focus on CMC development and/or commercial of novel drug candidates
- equivalency, consisting of a combination of appropriate education, training and/or directly related experience
- Very good understanding of the drug development process and associated regulatory framework
- Must be able to work with CTLs and influence multi-departmental initiatives
- work independently and with minimal supervision
- Must be an effective communicator (oral and written) with good follow up skills and working with multiple stakeholders
- Excellent project management skills - facilitation, planning, managing, budgeting, and execution
- Proficiency with MS Office Suite (Outlook, Word, Excel, PowerPoint, OneNote)
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
- Able to work upright and stationary and/or standing for typical working hours
- Able to lift and move objects up to 25 pounds
- Able to work in non-traditional work environments
- Able to use and learn standard office equipment and technology with proficiency
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards
- Ensures compliance with and maintains required training in relevant and departmental SOPs, GMPs, safety, and other guidelines
Desired Qualifications
- Experience in working/managing CTLs, primarily in analytical support
- Thorough understanding of cGMP's
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