Clinical Fill Finish Project Manager

Are you ready to embrace new and varied opportunities to develop and learn? As a Clinical Fill Finish Project Manager, you will be responsible for planning and managing all aspects of tech transfer, fill finish and assembly operations for production of liquid and lyophilized clinical Drug Products at manufacturing sites internally and externally. You will work collaboratively internally and externally to manage and oversee activities, ensuring that Biopharmaceutical Development (BPD) project goals and milestones are seamlessly achieved. This role provides the primary point of contact for AZ with the supplier in relation to assigned projects, influencing and ensuring that any issues are managed appropriately.

**Accountabilities**:
As a Clinical Fill Finish Project Manager, you will contribute to the operational effectiveness of Logistics and Clinical Supply. You will manage complex projects through internal or external suppliers/cross-functional teams, ensuring GMP operations and a sound understanding of the drug development process.

**Responsibilities**:

- Independently plan, manage and deliver technical transfer, fill finish, lyophilization and assembly operations as required for 4 to 8 specified Development Projects.
- Review vendor batch records and provide oversight for all manufacturing operations.
- Ensure cGMP compliance and all its related elements in documentation, reports and records.
- Perform supplementary aligned activities as required. Examples may include organizing end of shelf-life sterility testing activities, scheduling and enabling delivery of test results, scheduling and enabling DS or other bulk starting materials to supplied
- For assigned projects represent CFF activities at the Supply Continuity Team (SCT), and support the LCS Program Manager at other cross-functional project team meetings as may be required (e.g. CMC team). Contribute to overall supply planning, including Drug Product format and scheduling, and agreement of detailed distribution plans for Drug Substance, Drug Product and samples.
- Manage and expand close cross-functional relationships, negotiating and sharing information as relates to clinical supply activities. Ensure supply commitment and that milestone timelines are agreed and maintained to best meet the project objectives.
- Liaise closely with Quality Assurance (QA) activities with respect to Drug Product manufacture, release, inventory management and distribution, and as pertains to vendor selection, qualification and monitoring and all other compliance activities.
- Raise non-conformances when identified and participate in investigations to support on-time closure of deviation records
- Champion the production and maintenance of CFF project information and more generally support CFF SOPs, systems, tools and processes as required.
- Attend and actively participate in departmental meetings.
- Mentor, develop, and generally supervise the activities of co-workers ( LCS staff, summer interns, rotational associates, etc) assigned to flexible roles within the CFF team.
- Acts as point of contact to third party suppliers providing services to AZ.
- Collaborates to develop demand plan and and to execute supply activities against that plan, ensuring that agreed service / performance standards are met and that improvement opportunities are identified.
- Tracks spend and contributes to ongoing understanding of supplier performance.
- Communicates and aligns to ensure appropriate quality service delivery.
- Ensures project team satisfaction levels are maintained and feedback is collected and incorporated.
- Develops and maintains appropriate Project Level Agreements (eg Statement of Work) with providers and reviews performance against these agreed deliverables and against internal targets
- Resolves complex issues, working with internally and externally, and ensures learning is captured and incorporated into processed going forward
- Works independently under general supervision.

**Essential Skills/Experience**:

- Bachelor's degree in basic/applied science or engineering. Equivalent level of training in service may be considered
- Stakeholder management in a customer-facing role, partnering to achieve objectives
- Direct Experience in a Development or Technical Operations environment in the pharmaceutical, scientific or health care industry
- Previous experience managing delivery complex projects through internal or external suppliers/cross-functional teams
- Experience with GMP operations and a sound understanding of the drug development process
- Highly organized team worker with excellent attention to detail and strong communication skills
- IT proficiency appropriate to a systems-driven manufacturing role

**Desirable Skills/Experience**:

- Change responsive
- Process development/management experience
- Influencing and negotiation skills
- Financial and analytical skills
- Management skills appropriate to an effective mentor

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