Position plays a key role in pharmaceutical packaging as a member of cross-functional development programs supporting projects from concept through commercialization.
Job Function:
- Provide packaging technical support to External Manufacturing (ExM) and CMOs
- Transfer robust primary/secondary drug product packaging processes to Contract Manufacturing Organizations (CMOs)
- Assess and maintain packaging process performance at CMO
- Continuously reduce supply risks associated with packaging operations/processes
- Maintain knowledge of packaging types/technology/processes/equipment and serialization
Responsibilities:
- Support CMO selection (technical packages, due diligence, scoring)
- Lead packaging robustness assessment and improvement initiatives
- Lead technology transfer packaging projects; ensure robust transfer and complete regulatory filings
- Support operational management of packaging CMOs per governance model
- Provide ongoing technical support (metrics review, deviation closure, CAPA, change control, APQR, process improvement; implement OPEX)
- Lead process investigations using structured root cause analysis
- Technical lead for product robustness monitoring plan, process control strategy, and oversight of TPM sites
- Supervise MS&T specialist(s) when required
Education:
- Bachelor’s (or Master’s) degree in science, engineering, packaging or related field; minimum 6 years relevant experience
Experience/Knowledge Desired (required/preferred):
- Strong pharmaceutical packaging technology, technology transfer, process development, and packaging support experience
- In-depth knowledge of primary packaging (OSD blister: PVC/Alu, Alu/Alu, Aclar/Alu; HDPE/LDPE bottles; sealing; sterile/nonsterile liquids/semisolids: bottle/vial filling, tubes)
- Serialization requirements/technology; regulatory and compliance knowledge
- Knowledge of characterization/analytical techniques; packaging assessment methods
- Statistical software experience for capability/troubleshooting
- Strong communication/presentation skills
Benefits (if eligible):
- Health coverage (medical, pharmacy, dental, vision); wellbeing support; 401(k), disability/life insurance, and other protections
- Paid time off (flexible time off or 160 hours vacation for some locations/roles)
Application instruction:
- If the role doesn’t perfectly match your resume, apply anyway.