This company is a research-based Bio-pharmaceutical company that discovers, develops, and commercializes innovative medicines
in areas of unmet medical need. Its goal is to transform and simplify care for people with life-threatening illnesses
around the world. It has over 10,000 employees and is one of leading companies in its field.
This technical track position resides in the Commercial Packaging & Labeling organization at the company.
The Commercial packaging team is mainly responsible for supporting new product launches and market extensions, leading
capital projects, supporting packaging projects at contract manufacturing organizations, managing packaging component suppliers
and ensuring uninterrupted supply of commercial products to our patients.
Deliver technical leadership in the area of package engineering, identifying solutions to meet
stakeholder needs, partnering with suppliers and contract manufacturing organizations (CMOs), and driving manufacturing
Support new product launches and market extension projects.
collaboratively with multiple functional areas to meet complex project deliverables and ensure on-time delivery of project
Ensure product meets regulatory, performance, and cost requirements and maintain compliance
to current Good Manufacturing Practices (cGMP).
· Design, write, and execute packaging
study protocols such as shipping qualifications, transportation studies, label adhesion, etc. and issue reports.
Interface with contract manufacturers in weekly meetings for projects and routine production.
Review and approve protocols, master batch records, reports, and relevant CMO documents.
packaging equipment qualification and process validation (including IQ/OQ/PQ studies) to prove effectiveness of new packaging
configurations and/or packaging lines.
Perform qualification of primary packaging components (e.g., bottles, blisters, vials, prefilled
syringes, caps, stoppers).
Develop User Requirement Specifications for new packaging equipment and lines; request quotes
from equipment manufacturers for assessment by Company Management.
to and may lead technical investigations and deviations to drive expeditious and appropriate resolution.
labeling changes at CMOs and Company sites.
With minimal guidance, determines the functions most critical to departmental success and supports
Review existing SOPs and author new SOPs as necessary, relevant to Commercial Packaging &
Represent Commercial Packaging & Labeling in CMC sub-teams.
new employees in SOPs and documentation systems.
· Overnight travel may be required
up to 25% of time.
Lead departmental strategic initiatives. Contributes to and may lead complex processes across