Overview
On Site
Full Time
Skills
Crystal Management Console
LCM
Research and Development
Marketing
Quality Assurance
Collaboration
CMOS
Manufacturing
Evaluation
Regulatory Compliance
Distribution
Packaging Engineering
Pharmaceutical Industry
Documentation
Technical Writing
Project Management
Management
Soft Skills
Communication
English
Root Cause Analysis
Startups
Testing
Pharmaceutics
Job Details
Responsibilities:
- Support activities within MSAT-US, including the development of technical documentation, SOPs, and internal systems.
- Provide technical expertise in packaging and Pharma processes, equipment, materials, and component performance.
- Investigate and recommend new packaging technologies, systems, and materials for potential integration into Company packaging and Pharma manufacturing systems.
- Provide project management support for CMC and packaging projects related to late-stage NCE development, Life Cycle Management Programs (LCM), and Commercial Products.
- Collaborate with cross-functional teams (R&D, Marketing, Regulatory, QA, etc.) to develop project strategies and objectives.
- Lead or support the qualification of process and packaging equipment, including primary and secondary equipment, and transport systems for bulk/intermediates and finished products.
- Develop test protocols and manage the execution of studies such as transport qualification for bulk and finished drug products.
- Act as a technical and coordination focal point for multi-site projects involving CMOs and internal teams.
- Identify and recommend new processes and technologies that improve cost, compliance, and quality.
- Represent Manufacturing & Supply in the development, qualification, and launch of new products.
- Support the evaluation of primary packaging material systems for individual project objectives.
- Make recommendations on equipment and new drug product stability programs based on product protection, performance, and cost considerations.
- Demonstrate comprehensive knowledge of solid and liquid oral processes and packaging material types and their technical performance characteristics.
- Ensure compliance with relevant packaging material testing and performance requirements defined in USP, ASTM, ISTA, IATA, CFR, and FDA Guidance.
- Lead or support activities related to customer, supply, and distribution requirements in packaging and pharma processes.
- Produce technical reports and documentation to support new product registrations (FDA/EMA).
- Work in cross-functional teams to troubleshoot and perform root cause analysis.
- Travel to Toronto (2-3 times per year) to support process needs, estimated 1 week per trip.
- Education: Bachelor's Degree (or higher) in Process/Package Engineering. Candidates with MS or Ph.D. degrees will also be considered.
- Experience: Minimum 7 years in a similar role within the biotech or pharmaceutical industry, specifically in liquid formulations and packaging.
- Regulatory Knowledge: In-depth knowledge of FDA and EMA regulations, including documentation requirements.
- Technical Skills: Strong technical writing experience, with the ability to write reports, protocols, and technical documentation.
- Packaging Expertise: Knowledge of packaging systems and standards (USP, ASTM, ISTA, IATA, CFR, FDA Guidance).
- Project Management: Strong project management experience, with a proven ability to manage technical activities across multiple teams.
- Soft Skills: Excellent written and verbal communication skills in English. Ability to work in cross-functional teams, analyze data, and provide troubleshooting and root cause analysis.
- Travel: Must be willing to travel to Toronto and other locations as needed.
- Experience in equipment startup, qualification, and validation (Process and Packaging).
- Familiarity with packaging material systems and regulatory testing requirements.
- Biotech and Pharma experience, particularly in packaging and process support.
- Reimbursement will be provided for travel, and some overtime may be required during travel periods.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.