Packaging development Scientist
Packaging development Scientist
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Steriles Packaging Development & Design SOW DHF Role
The role is to be based at GSKs R&D site in Upper Providence Pennsylvania (US) and can offer flexible hybrid working. Occasional travel may be required.
Grade:
- Sr. Scientist / Investigator
Essential Qualifications:
- Bachelors degree in Packaging Engineering Device Engineering Packaging Science Chemistry Life Science with 3 years experience in parenteral or device package development primarily in pharmaceutical industry
- Design History File and Risk Management File experience in the pharmaceutical industry
Preferred Qualifications:
- Knowledge of integral and nonintegral parenteral packaging materials (such as vials stoppers PFS syringes needles) components vendors analytical equipment and technologies.
- Experience in sterile drug primary packaging development for large and small molecules including vial/stopper prefilled syringes and cartridges presentations.
- Knowledge of domestic and international device and packaging requirements and regulations (i.e. current applicable FDA/MAA guidelines USP/Ph Eur etc ISO).
- Knowledge of statistical analysis and Design of Experiments
- Ability to quickly establish relationships with internal and external stakeholders.
- Strong time management / organizational skills.
- Evidence of team working skills and flexibility.
Work Summary: To author DHF(s) and RMF(s) for a nonintegral co packed combination drug product in the UP PA site.
The task list outlined below provides a comprehensive summary of the crucial work that needs to be carried out in the Steriles Packaging Development team. This work is primarily aimed at projects related to Steriles ViiV projects in development at GSK.
Tasks:
- Support packaging and device development work streams for R&D combination and/or copackaged product development projects.
- Take ownership of device work packages coordinate testing activities (e.g. verification validation Design of Experiments robustness studies) to ensure device safety and performance.
- Responsible for managing Design History File (DHF) documentation.
- Author device development documentation including Design History Files (DHF) and Risk Management Files (RMF).
- Use problem solving skills and utilization of different strategies to support resolution of design manufacturing and regulatory challenges.
- Collaborate with multidisciplinary teams across GSK and international subcontractors.
- Participate in packaging and device risk assessments (e.g. user design or process risk assessments).
- Participate in design reviews at critical stages of development.
- Work closely with the manufacturing organization and suppliers to ensure that methods and processes are transferred for commercial production (as needed).
- Contribute towards continuous improvement activities to drive quality efficiency and consistency.
Stretch Tasks:
- Writing templates for DHF and RMF for nonintegral device packages
- Leading or supporting AAR with team to identify continuous improvement efforts
Employment Type
Full-Time
