Project Manager

The Project Manager will have responsibility for the overall management and set up of production process, budgets and critical materials for the projects assigned to themselves. Specifically, this will involve working to provide equipment/materials quotes for the specific project, preparing Master Batch Records (MBRs), Finished Product Specifications (FP Specs), label review and approval, specifying and ordering critical materials to be procured for the project, assisting with GMP Agreements and coordinating the production activities to deliver the clients requested outcomes in line with the agreements.

The primary responsibilities of this position are to:

• Accountable for overall project management for assigned projects/customers using appropriate project planning tools. Communicates milestones, critical path activities, and assigns internal and external responsibility to ensure the project achieves all deliverables per the customer requirements and agreed upon timelines
• Primary customer contact for clinical manufacturing, packaging and/or distribution activities and relationship management with the customer project teams for assigned projects/customers
• Responsible for leading Clinical Project Team Meetings and Technical Kick-Off Meetings for assigned projects
• Provide support to business development and estimation regarding new quotations and resupplies including identifying when contract amendments/change orders are required due to project scope changes
• Assessment of clinical protocols, study specifications, contracts, and other documentation to ensure we mitigate risk and provide our clients with the best service and experience
• Creates and reviews project specific documentation including master batch records, finished product specifications, sample shipment request forms, printing and issuance form requests, bill of materials spreadsheets, pharmacy manuals
• Ensures labels design and text is in accordance with the study set up and current regulatory requirements
• Forecasting and managing project expenses in adherence with the project budget
• Works closely with internal groups and vendors to ensure project milestones are achieved, including labelling and component design and delivery and on-time shipments of order requests
• Preparation of purchase orders for required medicines, raw materials, equipment and packaging materials required to execute the client’s trial
• Identify and liaise with contract 3rd party providers required to assist in the execution of projects (e.g. packaging materials, cGMP sterile manufacturers, couriers, analytical testing laboratories, etc)
• Allocates lot specific bulk and materials to the production labelling activity
• Review and approve internal customer-based specifications for packaging components and processes
• Provide suggestions for packaging solutions in the areas of design and specification management

The mandatory qualifications and experience for this position are:

• Tertiary qualification - Science, Pharmaceutical Sciences (additional business orientated qualification highly regarded)

• At least 5 years related experience - Pharmaceutical industry highly regarded

• In-depth understanding of clinical trials and supplies

• Excellent communication skills - Both written and verbal | Strong ability to connect and communicate with staff from all areas of the business

• Proficient in Microsoft Office suite, specifically Excel and Outlook

• High attention to detail and strong ability to prioritise and organise workload

• A positive can-do attitude

• Ability to manage time and conflicting priorities

• Ability to work in a fast-paced environment

• Ability to work as part of a team and with autonomy