Commercial Associate Project Manager I

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Commercial Associate Project Manager I assists with designated customer projects to ensure that objectives are accomplished within prescribed time frame and budget while adhering to applicable pharmaceutical regulations.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Facilitate the creation of item number requests for new projects and updates to revisions to existing projects

• Create and route Lot Expiry (LE) forms for assigned projects per the packaging schedule. Ensure routing is successfully completed in time to meet Packet readiness timeline.

• Create scheduling request for each packaging order and deliver to the Scheduling team, schedule requests should be submitted as soon as reasonably possible to meet client demand

• Create Sales Order and Work Order in ERP system (JDE) upon receipt of customer PO.

• Own the packet routing process for assigned clients – providing the Quality team with the requisite amount of time to complete the process and deliver the packet to the Operations Team.

• Communicate required bulk delivery dates to customers to meet packaging demand

• Create and manage Original Promise Date (OPD) in JDE for any required adjustments that impact delivery dates

• Track packet issuance metrics for assigned customers

• Monitor purchase order statuses to ensure on-time component delivery

• Maintain optimal component inventory levels to meet packaging orders – understanding component lead times and future forecast. Collaboration with Procurement is required.

• Order and ensure shipper labels and print mats/slugs are ready for maintenance and production requirements

• Responsible for the destruction of obsolete materials & expired materials as well as providing COFD to the customer (as required).

• Ensure obsolete materials are billed for and managed after a component revision or the end of a project once they are ship confirmed

• Collaborate with Central Parts or customer for the ordering of any TempTales

• Maintain communication with the Operations team during packaging runs to ensure all needs are met in a timely manner

• Facilitate the creation and routing of Change Orders that are required for packaging.

• Create sample requests as required by customers, ensure the appropriate instructions and documentation are contained for shipping.

• Partner with IQA to ensure timely release of components and bulk, ensuring all requirements are available ahead of component delivery

• Facilitate the documents required to transfer material between sites.

• Track releases of Finished Goods for timely shipment

• Prepare and distribute necessary shipping documents to the appropriate team members

• Review and approve documentation including specifications and batch records, as required.

• Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting.

• Training and onboarding for new employees within the same role, as requested.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the es