Operations Project Investigation Lead

at  Legend Biotech EU

COMPANY INFORMATION

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

EDUCATION:

• A minimum of a master’s degree in engineering , Science, Pharmacy or related field or equivalent experience required

EXPERIENCE:

• Minimum 8-10 years of operations experience within a cGMP environment (manufacturing/quality/development) in the biotech/biopharma industry and preferably cell/gene therapy.

CAPABILITIES, KNOWLEDGE, AND SKILLS:

• Knowledge of cGMP regulations and FDA/EU guidance related to ATMPs.
• Ability to work independently and successfully under minimal supervision and integrate cross-functional issues and balance competing priorities effectively.
• Self-motivated, enthusiastic personality, team player, with a desire to learn new skills.
• Excellent scientific writing skills.
• Being able to manage shifting priorities and multiple tasks simultaneously to meet critical deadlines in a fast paced and dynamic, growing environment.
• Flexible mindset capable to deal with ambiguity and to respond quickly, energetically, and enthusiastically to changes.
• Positive and pro-active attitude.
• Results driven while working within GMP framework of procedures and rules.
• Excellent organizational skills.
• Strong analytical mind, problem solving and critical thinking skills. Being able to trouble shoot and resolve complex scientific/technical problems.
• Advanced computer skills and practical knowledge.
• Clear communicator with ability to build strong partnerships.
• Accurate, Authentic, Transparent, Passionate, Fearless and Accountable.
• Coaching skills, being approachable, motivational and active listening.
• Ability to lead with influence as a change agent to promote flexibility, creativity, and accountability.
• Eager for improvement and efficiency increase.
• Strategic thinking and helicopter view.

ROLE OVERVIEW

The Operations Investigation Lead will be part of the Operations project team and has the responsibility to:

• Timely manage, coordinate and follow-up of Investigations within Operations.
• Oversee the interface between the different internal manufacturing operational departments to ensure smooth communication flows for operational investigations, clearly defining roles and responsibilities between the different stakeholders to thrive an efficient and on-time investigation handling.
• Participate in balancing the investigation house capacity and support, to maintain agile throughout the different company milestones.
• Building strong long-lasting relationships with external stakeholders to ensure clear alignment on responsibilities, timely communication and easy data retrieval in support of safe and on-time product release.
• Coaching, mentoring and further developing the operations investigation team by, i.a. setting up adequate training curricula for investigation experts.
• Own the investigation process and methodologies for operational investigations, create awareness and educate the operations organization on the importance of and how to adequately and efficiently handle quality investigations in time.
• Participate in maintaining and further optimizing the investigation tracking and supporting QEM systems, while following up on investigation metrics to allow timely and adequate prioritization setting, escalation and keeping the investigation process under a state of control.
• Oversee investigation processes and standards and support the implementation of CAPAs related to the manufacturing process together with MS&T process expert, process engineer and knowledge management.
• Ensure a system is in place for upfront preparation of Regulatory Authorities inspection requests related to Operational subjects. Being accountable to defend the strategy, investigation reporting and potential answer to observation.
• Contribute to the strategic plan by building up CAR-T and cGMP specialist capability/expertise (SME) to thrive improvement of Product Quality, Safety and Efficacy.

MAJOR RESPONSIBILITIES

Operations expertise:

• Continuously gather the operational knowledge of the cell and gene therapy manufacturing process technology to provide expertise input during operational investigations.
• Participate in multi-disciplinary investigations and provide operational input needed for sub-parts of any investigation.
• Coach and support operational investigation expert team in gathering operational knowledge.

• Supervising the interfaces between operations and other departments to support an adequate system in place for smooth deviation handling.

  Quality & Compliance:

• Understand and implement the importance of GMP aspects in your investigations. o Take the lead in investigating and reporting deviations regarding GMP.

• Support other departments in investigating deviations related to other aspects of production (process, QA, Q) as needed.
• Participate in applying and implementing appropriate risk assessment methodologies and root cause analysis tools and assess product quality impact.
• Ensure a system is in place for upfront preparation of Regulatory Authorities inspection requests related to operational subjects. Act as SPOC within operations and be accountable to defend the strategy, investigation reporting and potential answer to observation.
• Act as operations SPOC for Regulatory Authorities inspection of operational subject, accountable to defend the strategy, investigation reporting and potential answer to observations that he/she managed or coordinated.
• Stay up to date with GMP/regulatory requirements and state of the art guidelines, maintain permanent inspection readiness, actively support regulatory inspections and preparation thereof as SME, and support the implementation of actions resulting from such inspections.
• Coordinate, review/revise, and/or support writing of (not limited to):
• Investigations (incl. impact and risk assessments, corrections, CAPAs)
• Change controls
• Memo’s
• Continuously maintain compliance with internal training requirements and follow up on training requirements of the Ops investigations team.
• Recognize and act on potential compliance issues and opportunities for process changes/improvement.

Continuous Improvement:

• Support the implementation of quality investigation resulting CAPAs related to the manufacturing process.
• Act as leading and driving force to further develop and improve the investigation dashboard and supporting QEM systems along with other departments.
• Ensure connection between recurrent deviations and process robustness activities, perform trending and feed the operational organization based on lessons learned from investigations.
• Contribute to technical feasibility studies related to process improvement and implementation of new manufacturing and automation technologies.
• Provide operational expertise and assist in performing technical feasibility studies to support the implementation of process improvements, new manufacturing technologies and automation, that would provide reduction in COGs, increase throughput, capacity and quality compliance. o Contribute to the strategic plan by building up CAR-T production and cGMP specialist capability/expertise (SME) to thrive improvement of Product Quality, Safety and Efficacy

People management:

• Aid in selecting and setting up an investigations team that is fit for GMP investigations, has the right expertise/skills/mindset and is properly trained.
• Exhibit strong Leadership skills and ability to effectively communicate and influence operational investigations team.
• Coach, develop and assess all team members.
• Maintain a clear view on capabilities and capacity within your team and follow up by e.g. setting up adequate training curricula for investigation experts. o Follow up on investigation statuses and progress with team members and apply efficient crisis management if investigation deadlines cannot be met. o Report about operational investigation progress to Ops project manager and flag any roadblocks or escalations to ensure smooth handling of deviations.
• Build strong partnerships in a matrixed environment, i.a. by liaising with different internal crossfunctional teams such as MS&T, QC (IPL), Supply Chain, Engineering and Quality, as well as effectively integrating with external collaborators