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Clinical Fill Finish Manager - LCS

Ort Gaithersburg, Maryland, USA Anzeigen-ID R-090964 Veröffentlichungsdatum 09/25/2020

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Key Responsibilities

  • Provide general oversight for CFF activities within LCS
    • As required play an active role in technical management of LCS CFF managers including providing technical direction /support and input to definition of robust CFF manager assignments
    • Where necessary ensure project continuity through key transition events and staff absences
    • As required provide direct oversight and supervision to specified studies managed by other members of the CFF group
    • As necessary support BPD portfolio through oversight and management of Drug Substance (DS) and Drug Product transfers to/from fill finish vendors
  •  Independently plan, manage and deliver all aspects of CFF support for assigned development projects and/or in relation to specified vendors at all development stages (Phase 1 to Phase 3 supply).  Provide leadership, oversight and management for technical transfer, fill finish, lyophilization and assembly operations
  • Ensure close liaison with R&D Quality Assurance (QA) in relation to Drug Product manufacture, release, inventory management, distribution, and for vendor selection, qualification and monitoring.  Throughout, ensure cGMP compliance of CFF activities and all related elements in creation and maintenance of documentation, reports and records
  • Enable information exchange and supervision of activities related to CFF related non-conformances received from manufacturing vendors, couriers, or internal departments.
  • Review vendor batch records, and support delivery of end of campaign reports and regulatory submissions as required
  • As required, lead identification and establishment of vendors for clinical Drug Product fill finish activities and provide on-going supplier management and oversight
  • For all assigned projects, represent CFF as an engaged and active member of the Supply Continuity Team (SCT).  Support the LCS Program Manager at other cross-functional project team meetings as may be required (e.g. CMC team).  Liaise with all parties as appropriate to provide alignment of Drug Product clinical production scheduling (including appropriate number and timing of manufacturing runs) and transparency of supply chain lot history
  • Contribute to and influence development of overall supply strategy, including Drug Product format and scheduling, resolution of any planning gaps or inventory shortfalls, and agreement of detailed distribution plans for Drug Substance, Drug Product and samples
  • Maintain & expand close cross-functional relationships, liaising with Stakeholder groups to develop, communicate and deliver a risk mitigated supply strategy.  Ensure that any issues that could impact on product supply are highlighted and that solutions are provided for the project and for other similar projects in Development
  • Influence and enable development of optimal working practices, systems, and tools to ensure robust delivery of responsibilities including clear stakeholder communications
  • Apply skills and knowledge to advise and develop improvements and future growth opportunities for CFF such as would support the preparation of new clinical projects, and/or delivery of novel Drug Product presentations.  Ensure that CFF supplier base and working practices remain well aligned to business requirements
  • Collaborate and manage long range development of manufacturing vendors including Key Performance Indicator (KPI) based performance management and target setting in line with pipeline requirements
  • As a member of the LCS Senior Management team, play an active role in operational management of the group including deputizing for other managers as required
  • Lead departmental process improvement initiatives as required
  • Represent LCS in cross-functional initiatives of moderate business impact such as would benefit the design and establishment of new or improved supply chain processes
  • Apply own unique training and expertise to deliver against flexible assignments within other LCS roles as required
  • Mentor, develop and supervise the daily activities of LCS staff acting either as technical point of contact, or in relation to matrix team members.   Enable through others highly effective CFF operations, team working and overall supply delivery
  • As required, act as Line Manager for LCS staff enabling delivery through direct reports and advancing employee engagement and development.
  • Communicate seamlessly within assigned teams, BPD, and with all interfacing functions and relevant groups as required.

Requirements/Qualifications

Education

Requires a Bachelor’s degree in basic / applied science or engineering.  In lieu of degree an equivalent level of training in service (4+ years) may also be considered. 

The Senior Clinical Fill Finish Manager will have appropriate direct experience in a development or technical operations environment in the pharmaceutical, scientific or health care product industry. 

Specific experience in the management, development and preparation of aseptically produced products, and in Investigational Medicinal Product (IMP) management and supply is highly desirable.

Experience

Requirements/Qualifications

Requires a Bachelor’s degree in basic / applied science or engineering.  Equivalent level of training (4+ years) in service may also be considered. 

A minimum of a Bachelors degree and at least 4 years of relevant experience (8+ years of experience in lieu of degree)

  • The CFF Manager will have appropriate direct experience in a development or technical operations environment in the pharmaceutical, scientific or health care product industry.  Specific experience in the management, development or preparation of aseptically produced products is desirable.

  • Broad knowledge of the Biotechnology and/or Pharmaceutical industry and demonstrated ability to achieve results in a cross-functional, multi-product environment

  • Direct experience with managing GMP fill/finish operations, and sound understanding of the drug development process
  • Thorough understanding of cGMP environment and guidelines, Code of Federal Regulations, and FDA Guidance for Industry
  • Experience managing people (either as line or matrix manager) preferred, and proven ability to work in a dynamic environment and collaborate within cross functional project teams to deliver complex projects

Special Skills/Abilities

This position requires a high level of commitment, flexibility, initiative and independence with strong skills for planning, coordination, teamwork, communication and interpersonal relations.  The Senior Manager will be highly organized and have strong analytical skills whilst demonstrating keen attention to detail, aptitude for troubleshooting on technical and process related issues, and appropriate tact and diplomacy in building / managing interface relationships



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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