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Clinical Fill Finish Manager
hace 4 meses
About AstraZeneca
AstraZeneca is a global, science-led, patient-centric biopharmaceutical company focused on the discovery, development, and commercialization of prescription medicines. Join the team dedicated to BioPharmaceutical Development.
About the role
As Clinical Fill Finish Manager, you'll
act as the point of contact for third-party suppliers providing services to AstraZeneca - chiefly fill-finish and device assembly suppliers.
Also, you'll collaborate to develop demand plan and to execute supply activities against that plan, ensuring that agreed service/performance standards are met and that improvement opportunities are identified.
- 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. The number of projects undertaken will be dependant on the services that are being managed and their complexity.
- Works collaboratively internally and externally to manage and oversee activities, such that Biopharmaceutical Development (BPD) project goals and milestones are seamlessly achieved.
- Provides primary point of contact for AZ with the supplier in relation to assigned projects, influencing and ensuring that any issues are managed appropriately.
- Contributes to the operational effectiveness of Logistics and Clinical Supply.
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 endofshelflife sterility testing activities, scheduling and enabling delivery of test results, scheduling and enabling DS or other bulk starting materials to be supplied.
- For assigned projects represent CFF activities at the Supply Continuity Team (SCT), and support the LCS Program Manager at other crossfunctional 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 crossfunctional 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 nonconformances when identified and participate in investigations to support ontime 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 coworkers (LCS staff, summer interns, rotational associates, etc) assigned to flexible roles within the CFF team.
Essential for the role
- Bachelor's degree in basic/applied science or engineering. Equivalent level of training in service may be considered.
- Stakeholder management in a customerfacing role, partnering to achieve objectives.
- Direct Experience in a Development or Technical operations environment in the pharmaceutical, scientific, or healthcare industry.
- Experience managing delivery of complex projects through internal or external suppliers / crossfunctional 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 systemsdriven manufacturing role.
Desirable for the role
- Change responsive.
- Process development /management experience.
- Influencing and negotiation skills.
- Financial and analytical skills.
- Management skills appropriate to an effective mentor.
Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
So, what's next?
Are you already imagining yourself joining our team? Good, because we can't wait to h
