Sterile Fill Finish Associate Project Manager

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JOB DESCRIPTION:

Position Title: Sterile Fill and Finish (SFF) Associate Project Manager

Location: San Diego, CA

The Sterile Fill and Finish (SFF) Associate Project Manager position will provide continuous support to the Project Manager and team by being the daily point contact for day-to-day internal problem solving and troubleshooting
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Provide continuous support to Project Manager and team by being the daily point contact for day-to-day internal problem solving and troubleshooting.
• Preferred to be familiar with the operations of the Cytiva sterile isolators and the associated formulation and processing equipment.
• Leads weekly customer calls and Sterile Fill Finish Project Team meetings in absence of Project Manager or as designated.
• Record meeting minutes for weekly customer teleconference calls and internal Sterile Fill Finish Project Team meetings as instructed.
• Communicate timeline and scope change concerns to Project Manager. Assess client requests and ensure scope changes are communicated to Project Manager and Sterile Fill Finish management for evaluating need for a change order, to management for escalation, and to other departments as necessary.
• Drafts project specific documentation including sample shipment request forms, sample submission forms, material specifications, product specifications, material inventory reports, packaging/labeling protocols, variable data forms, etc.
• Coordinates with cross-functional teams to ensure timely receipt and release of bulk drug substance, sterile processing components, cleanroom supplies, clinical packaging components, and shipping supplies.
• Communicates with customers and vendors to resolve missing certs and release documentation related to receiving and QC release of bulk drug substance, sterile processing components, cleanroom supplies, clinical packaging components, and shipping supplies.
• Assists Project Manager in project or program related communications to 3rd party labs/vendors and internal network stakeholders for product or material release testing.
• Prepares project-specific production readiness documentation and ERP set-up including bill of materials, work orders, packaging and labeling batch records, label proofs, etc.
• Works closely with internal groups and vendors to ensure project milestones are achieved, including labeling and component design and delivery and on-time shipments of order requests.
• Coordinates with cross-functional teams for production job staging of bulk drug substance and ancillary sterile processing components.
• Works with customers and sites to resolve discrepancies on end of study returns.
• Creates Destruction Authorization Forms and forwards to customer for destruction approval of returns, remaining finished goods, and customer owned inventories.
• Records data in project specific metrics.
• Resolves shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites.
• Assumes the role of the client advocate and acts as secondary client communication point for sterile fill finish, clinical packaging, storage, and distribution for assigned projects. Acts as back-up Project Manager contact for internal communications and troubleshooting.
• Ability to field process-related technical questions for any assigned projects from both internal customers and external customers in the absence of the Project Manager.
• Accountable for assigned project tasks using appropriate project planning tools. 
• Support Sterile Fill Finish and Clinical leadership on improvement opportunities and strategic initiatives.
• Participate in meetings and reporting with Project Management, Operations, and Quality management.
• Training and on-boarding of new employees within same role as requested.
• Maintains and updates project plans and timelines as requested.
• Knowledge of and adherence to all PCI, cGMP, GDP and cGCP policies, procedures, rules and regulations applicable to assigned clinical projects.
• Ability to author production and technical documents.
• Expected to support project activities outside of core hours as necessary. This position may require overtime and/or weekend work.
• Attendance at work is an essential function of this position.
• Performs job duties as assigned by Manag