Packaging Manager, MS&T

Packaging Manager, MS&T contract / remote

• Reporting into the Associate Director, Manufacturing Sciences & Technology, the role will provide scientific and technical leadership and contribute towards pack engineering (pack design, testing, validation), packaging equipment sourcing and qualification, primarily external packing activities with some support for internal packing activities at manufacturing.

• This position provides technical support, oversight and expertise to the External Manufacturing Supply Team for packing activities being conducted by external contract manufacturing organisations (CMOs) including technology transfer, new product introduction, market launches, new equipment introduction, troubleshooting relating to packaging finished goods. This role supports validation activities under established program strategy.

• Other responsibilities include participation in cross-functional teams, preparing technical sections of reports.

• The role works in close collaboration with the FG External manufacturing leads who are the primary owners of the team processes, tools, metrics, and all aspects of project management to ensure successful packaging and supply of product to patients.

Essential Functions/Responsibilities

• This position is responsible for providing support and oversight linked to multiple technical packaging related project both internally and externally.

• Support investigations/ troubleshooting into quality, safety, and downtime issues in manufacturing areas relating to packaging, using RCA tools as appropriate. Responsible for actively managing/ supporting all Quality System items related to packaging e.g. deviation investigations, CAPAs, Change Controls.

• Support qualification and validation activities associated with new equipment introduction, new market launch requirements, new product introductions.

• For external manufacture at CMOs, input into, pack design, oversight of packaging process and qualification activities.

• Identify projects for continuous improvement of packaging processes, materials and equipment within external packaging facilities.

• Support development activities associated with scaling up manufacturing processes under established strategy.

• Support authoring / review of regulatory CMC modules.

• Act as SME during internal/ corporate, customer and regulatory audits.

• Apply project management tools to track assigned deliverables, support on-time and in-budget execution, and ensure effective communication with key stakeholders.

• Support the delivery of company/site objectives to the required Quality, Regulatory and EHS standards.

• Clearly and effectively communicate ideas and results, written and verbal, to technical and non-technical audiences.

• As member of the External Manufacturing team, deliver of Quality, Compliant, Reliable and Cost-Effective Commercial Supply across Jazz’s External manufacturing network, attend meetings, provide MS&T input into decisions for products and communicate output with MS&T team.

• Support Packaging Robustness, Investigations, Yield & Continuous process improvements for external packaging at CMOs.

• Highly flexible, works well in a team environment, and has necessary skills to organize, mobilize, communicate, & influence.

• Where required, deputise for and sign off relevant documentation in place of Associate Director, Manufacturing Science and Technology.

Person Spec

• Will have relevant technical experience working in a regulated industry, preferably pharmaceuticals with demonstrable knowledge of cGMP (> 5 years).

• Experience at maintaining operational standards to global regulatory requirements.

• Excellent communication skills, including written, presentational, formal report writing.

• Experience in senior stakeholder management, and working in cross functional teams (internally and externally).

• Experience in defending processes, procedures and investigations during FDA/EMA inspections is desirable.

• Proven hands-on experience in GMP packaging and validation activities.

• Project management skills and experience of setting and managing performance to financial budget.

• Ability to effectively participate in multi-disciplinary teams and proficient in working with CDMO vendors.

• Strong personal ownership for skill / technical development.

• Professionally qualified / equivalent experience in relevant technical field.

cv to [email protected]