Job Details:
In this dynamic role you will organize Technology Transfer activities for Final Drug Product manufacturing. Supporting and creating project schedules, dashboards and leading team meetings to progress the project final objectives. This will include working across a global and cross functional team consisting of manufacturing, device and packaging design for combination product, capital projects, physical test methods, quality and regulatory team members. To effectively serve patients, we build effective Technology Transfer plan and schedule for our combination products that enhance end to end controls with robust methods with data flow to our digital infrastructure in a GMP setting.
Responsibilities of this position may include:
Supporting Tech Transfer project scheduling activities for FDP.
Support New Product Introduction to manufacturing site.
Owning documentation such as Project Plan, supporting engineering with PTD (Process Transfer Document), Protocols and reports.
Supporting engineers with M-a-B (Make-a-Batch) activities to make sure the sending/receiving sites expectation are met.
Developing, tracking and providing project dashboard updates.
Providing good communication plan to cross functional team and Process Engineer management.
Ability to apply project management and engineering science to production.
Strong teamwork, excellent interpersonal and communication skills.
Basic Qualifications:
Master degree OR
Bachelor degree and 2 years of experience OR
Associate degree and 6 years of experience OR
High school diploma / GED and 8 years of experience
Experience in a Combination Product field with a focus on project management and/or manufacturing.
Experience and knowledge of interdependencies of complex projects with new product introductions with new equipment/processes.
Knowledge of Combination Product design controls and Regulatory requirements on a global scale
Understanding of commercialization framework.
Program and Project Management skills (experience with MS Project, SmartSheets and other project scheduling software is desired)
PMP certification is desired.
Proactive risk assessment, management and mitigation.
Ability to lead and succeed in ambiguous environment.
Strong project management skills.
Basic Qualifications
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
Top 3 Must Have Skill Sets:
• Excellent written and verbal communication skills together with demonstrated ability to work in a team environment.
• Direct experience with medical devices/combination products and associated manufacturing process.
• Experience of working with equipment suppliers and contract manufacturers.
Day to Day Responsibilities:
The Process Engineer is expected to engage a network of FDP expertise across the commercial and clinical operations for product (device) assembly, label and packaging. The position is expected to leverage this network in support of the technical transfer process, design for manufacturability of new combination products, performance trending of existing combination products, equipment standardization and troubleshooting/process improvements.