Head of Cell Banking Center of Excellence - Boston, United States - ARIAD

ARIAD

Verified Company

Boston, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Small Molecules

Biologics
Plasma
Cell and Gene

As part of the GMS team, you'll have the opportunity to pursue unique experiences and build new skills, and you'll know that the work you do every day makes an impact — on our patients, our people, our planet, and on yourself.

Job ID R0123360
Date posted 05/20/2024
Location Boston, Massachusetts
Job Title: Head of Cell Banking Center of Excellence

Location:
Lexington, MA

About the Role:

As the Head of Takeda's Cell Bank Center of Excellence (CoE), you will be responsible for management and oversight of the Cell Bank CoE project portfolio and 5 year strategic roadmap.

You will participate in business development opportunities, lead/guide project teams (where applicable) aimed at delivering value for the Cell Bank end-to-end value chain, participate and engage with biopharma industry consortia forums, and coordinate/ facilitate recurring global CoE governance meetings.

You will provide management oversight and administration of Cell Banking Center Of Excellence (COE), including Cell Bank Manufacturing Operations.

You will manage the activities of the staff, monitoring the maintenance of equipment and facilities in production, overseeing complete documentation of all required production activities and ensure compliance with current Good Manufacturing Practice regulations (cGMP), Standard Operating Procedures (SOPs), product licenses, corporate policies and safety practices.

You will report to the Head of Manufacturing Sciences.

How you will contribute:

Partner to establish operational capability and flexibility to produce Master and Working Cell Banks and establish Cell Bank as the Center of Excellence for the global network.
Be a member of the Manufacturing Science Leadership Team, responsible for developing strategic plans that support the goals, objectives and priorities for the cell banking COE organization.
Oversee the Cell Bank manufacturing area schedule to ensure market and inventory demands are met.
Develop/Improve business process for Cell Bank Operations and partner with stakeholders and customer to develop a global community of practice
Provide support for project portfolio management (capital projects and technology transfers) and interdepartmental collaboration to provide continuity between manufacturing plants
Participate in proactive measure to promote a positive safety culture to ensure zero incidents, injuries, and the protection of people, property and the environment through communications, review of EHS performance metrics and incident reports.
Champion selfinitiated projects and drive area under their control within the context of corporate and functional area priorities; justify goals to senior management and lead crossfunctional projects and teams encouraging teamwork to drive project/process improvements.
Lead project teams in defining program strategies and goals, and assigns/manages project tasks as applicable to meet Cell Bank CoE objectives and manage CoE Governance meetings and strategic alignment to Cell Bank CoE Network Operational model
Lead in activities to increase Cell Bank site capacity and capability to support Takeda's Biologics pipeline of programs.
Work with departments including Regulatory, Supply Chain QA, QC, Pharmaceutical Sciences Cell Line Development, MFG, and Finance to maximize efficiency and ensure best practice approaches for the compliant intake, manufacture, qualification, testing, release, storage, transportation, and approval of cell bank supply for clinical and commercial programs.
Lead establishment of centralized and accessible electronic systems for Cell Bank knowledge management, project, and data analytics.
Engage with global Supply Chain, product teams, and network sites as applicable to provide information on changing requirements or risks to cell bank inventory or overall product lifecycle.
Lead Cell Bank Tech Transfers for internal and external activities and support capital projects and supports projects as they relate to continuous improvement projects for Manufacturing Operations.
Support planning for local or global Change Controls with applicable stakeholders.
Bridge technical and business disciplines as they relate to cell banking COE activities.
Participate in facility and process inspections by domestic and international regulatory agencies
Ensure that all procedures and records are maintained to reflect current manufacturing methods and in conformance with product licenses and that production equipment and facilities are maintained in proper working condition and in a validated state through use quality systems (e.g. change control)
Ensure submission and completion of all area quality documentation to meet established timelines, compliance commitments are completed on time and provide documented evidence to support closure of each item according to the established timeline and Cell Bank operations align to global