Job Title: Technical Operations Associate Director
We are seeking a highly skilled Technical Operations Associate Director to join our team.
This role operates at the forefront of excellence through partnership, ensuring end-to-end integrity of the commercial supply network. Our ideal candidate will deliver quality medicines to patients safely, efficiently, and with value while fostering diversity, inclusion, and belonging.
1. Develop influential relationships with internal and external stakeholders, providing technical leadership and packaging engineering expertise to external supply teams. This involves supporting the management of Contract Manufacturing Organizations (CMOs) in the supply network.
2. Provide technical input and guidance on drug product and packaging CMO vendor selections and technology transfers. Collaboration with Pharmaceutical Development ensures network capabilities for tech transfer to CMOs as needed.
3. Lead the implementation of new technology or upgrade projects at external CMO packaging sites, working closely with internal and external stakeholders.
4. Offer technical input and operational support during packaging IQ/OQ/PQ and PPQ qualification studies led by CMO Validation/External Quality.
5. Contribute technical expertise for primary and secondary packaging development and shipping development studies to support new product introduction.
6. Provide technical oversight at CMOs for Packaging Engineering trials related to new product introduction changes to packaging components/processes or internal changes. Ensure controls are documented in Standard Operating Procedures (SOPs) or batch records and continually updated.
7. Maintain a Packaging Control Strategy as a lifecycle document and identify critical parameters for all packaging processes.
8. Offer technical input and leadership support to drug product processes, solid oral vial syringe filling troubleshooting, and continuous improvement with key stakeholders.
9. Contribute to regulatory filings and CMC as required.
10. Provide technical leadership into drug product and packaging investigations with CMOs and cross-functional support teams to ensure root cause is identified and sustainable Corrective Actions Plans (CAPAs) are in place.
11. Responsible for day-to-day process operations conducted by CMOs, act as process owner for manufacturing processes, and ensure efficient operation to supply products to patients.
12. Collaborate with network suppliers, internal and external, to publish Key Performance Indicators (KPIs) focused on delivering efficient processes.
13. Apply the latest engineering techniques to reduce time to market while meeting regulatory requirements, deadlines, and costs. Collaborate with other departments to meet production quality and safety targets and drive improvements to reduce customer complaints.
14. Identify and mitigate risk through active participation in risk management processes.
15. Maintain and develop packaging competency library for current and future product strategies.
16. Collaborate with PharmDev to develop new drug products and packaging designs suitable for commercial operations across the network.
17. Provide technical expertise in drug product manufacturing operations, including process development and troubleshooting input to future site/process selections for new products.
Qualifications:
* Engineering or Science Qualification Bachelor's/Master's preferred with significant drug product and packaging engineering experience in high-volume pharmaceutical/healthcare packaging experience with new product/process introductions in accordance with EHS and cGMP standards.
* Experience in a cGMP environment with strong discipline in change control and risk assessment to evaluate processes and implement improvements.
* Proven problem-solving abilities with the ability to identify facts, consider alternatives, and close investigations and CAPAs in a timely manner.
* In-depth knowledge of primary and secondary packaging for pharmaceutical products with an understanding of global regulatory requirements related to design and control.
* Drug product operations experience in oral solid dosage vial and syringe filling.
* Strong mechanical capability with hands-on experience with equipment experience in a technical role within high-volume manufacturing preferred.
* The ability to read and interpret complex engineering drawings and understand geometric dimensioning and tolerancing as it relates to packaging design.
* The ability to quickly understand new technologies, grasp operating principles, and troubleshoot with technical teams.
* Excellent verbal and written communications, including technical reports and investigations, with strong presentation and influencing skills.
* Approximately 20% domestic/international travel expected.