Qureos Mentor

Legend Biotech

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 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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&amp;D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
 
 
 
 
 
 
 Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson &amp; Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). 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.
 
 
 
 
 
 
 Legend Biotech is seeking an
 
 Operations Specialist
 
 as part of the
 
 Technical Operations
 
 team based in
 
 Raritan, NJ
 
 .
 
 
 
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 Role Overview
 
 
 
 
 This position will be responsible for providing operational support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. This individual will partner with Technical Operations in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements. The individual will be responsible for driving and implementing a wide variety of improvements, ensuring alignment in support of the overall objectives and priorities of the plant. The role will require communication, coordination and collaboration across relevant cross functional groups to enable robust production, testing and release of product to patients.
 
 
 
 
 
 
 Key Responsibilities
 
 
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 Provides general support to all Operating Areas, e.g. Manufacturing, Warehouse, Logistics, Support Labs.
 
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 Collaborates with Technical Operations who are responsible to provide process knowledge and expertise in support of GMP investigations, change controls, document control, process improvement, process validation and data management.
 
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 Partners with Operational Excellence to implement improvements.
 
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 Writes, reviews, owns and updates SOPs.
 
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 Owns, provides assessments and takes actions in support of change controls.
 
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 Owns CAPAs and associated project plans.
 
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 Supports events such as Root Cause Analysis (RCAs) and FMEAs.
 
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 Participates in kaizens and other project initiatives.
 
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 Supports any business improvement efforts.
 
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 Supports permanent inspection readiness and actively supports internal audits and regulatory inspections.
 
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 Provides input to studies related to process improvement and implementation of new manufacturing technologies and associated protocols.
 
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 Provides input and supports improvements related to the aseptic environment and technique.
 
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 Job duties performed routinely require exposure to and handling of biological materials and hazardous chemicals.
 
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 Distance visual acuity of at least 20/40 (Snellen) in both eyes without corrective lenses or visual acuity corrected to 20/40 (Snellen) or better with corrective lenses.
 
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 Color Perception both eyes 5 slides out of 8.&nbsp;
 
 
 
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 Requirements
 
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 BS/BA required in technical discipline: Engineering, science or similar field.
 
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 GMP Manufacturing, Warehouse and Logistics experience in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
 
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 Fundamental understanding of Lean principles and tools, Lean Six Sigma Green desirable.
 
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 3+ years of experience leading and/or supporting improvement or remediation efforts.
 
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 Strong understanding and proven application of problem solving tools and techniques.
 
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 Demonstrated experience ownings SOPs, change controls, investigations, CAPAs and other quality system actions.
 
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 Ability to engage all levels of the organization, from site leadership to the shop floor.
 
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 Proven experience working and leading in a matrix environment.
 
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 Able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
 
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 Strong ownership skills and ability to work independently.
 
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 Strong analytical, problem solving and critical thinking skills.
 
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 Excellent organizational and communication skills.
 
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 An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment.
 
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 Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
 
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 Clear and succinct verbal and written communication skills with an attention to detail and the ability to follow procedures.
 
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 Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
 
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 Physical dexterity sufficient to use computers and documentation.
 
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 Solution-oriented mentality, capable of developing new procedures and alternate paths to overcome identified opportunities for improvement.&nbsp;
 
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 The anticipated base pay range is: $75,972 USD - $99,713 USD
 
 
 
 
 
 Benefits
 
 
 
 
 We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth. Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one. Equity and stock options are available to employees in eligible roles, we offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays. Additional benefits include flexible spending and health savings accounts, life and AD&amp;D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
 
 
 
 
 
 
 
 
 EEO Statement
 
 
 
 
 Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend&rsquo;s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.
 
 
 
 
 
 
 Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.
 
 
 
 
 
 
 Legend Biotech maintains a drug-free workplace.
 
 
</div>

Operations Specialist

<div>
 
 
 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, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&amp;D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
 
 
 
 &nbsp;
 
 
 
 Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson &amp; Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). 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.
 
 
 
 &nbsp;
 
 
 
 Legend Biotech is seeking
 
 AD, Site Supply Chain
 
 as part of the
 
 Supply Chain
 
 team based in
 
 Raritan, NJ.&nbsp;
 
 
 
 
 
 
 
 Role Overview
 
 
 
 The Site Supply Chain Lead will be part of the Manufacturing Technical Operations team responsible for leading Supply Chain planning, inclusive of Production Planning &amp; Scheduling, Materials Planning, and Batch Logistics, within a personalized cell therapy-manufacturing site. This individual will partner with the plant leadership team, various Technical Operations and Quality functions to support both clinical and commercial manufacturing operations, in accordance with cGMP requirements, and company policies &amp; procedures.
 
 The position requires proven leadership and expertise conducting in-depth supply/capacity planning, with the ability to optimize and balance production schedules, inventory coverages, and key site operational resources to meet production slots and patient demand, while providing optimal service levels, cost adherence and performance.
 
 
 
 
 Key Responsibilities
 
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 Plan, lead and oversee the tactical and operational production plans for the site, in close collaboration with key cross-functional site stakeholders, and in alignment with the Sales &amp; Operations Planning (S&amp;OP) forecast
 
 
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 Analyze and provide input on manufacturing capacity, develop exception planning scenarios (Short-Mid-Long range) and contingency strategies to meet manufacturing scheduling plans and patient runs
 
 
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 Oversee execution of the site detailed production schedule in close collaboration with Manufacturing Operations
 
 
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 Develop, interconnect, maintain, and actively manage functional stakeholder relationships to enable assembly and execution of an optimized/aligned plan
 
 
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 Lead and integrate other planners that support areas or functions and those plans into a master plant production schedule
 
 
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 Monitor progress-to-plan by proactively identifying threats/challenges that jeopardize the production plan and work to pull functional stakeholders together in order to prioritize and develop contingency/mitigation strategies to ensure manufacturing operations and scheduling continuity
 
 
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 Partner, support and communicate frequently with V2V, Manufacturing Operations, Planning &amp; Procurement counterparts to ensure daily and longer-term production plans are successfully achieved
 
 
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 Develop strategic planning methodologies and tools that translate all end-to-end Manufacturing &amp; Supply Chain requirements/activities into scalable and sustainable operations upstream/downstream
 
 
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 Oversee material requirements planning (MRP) to ensure uninterrupted supply of critical components.
 
 
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 Monitor inventory levels and implement best practices for safety stock and demand variability.
 
 
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 Lead and perform future forecasting analysis that maintains certain flexibility and optimized resource capacity and utilization
 
 
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 Design, implement and oversee execution of Supply Chain business process in SAP and other relevant manufacturing/planning systems
 
 
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 Drive continuous improvement initiatives leveraging Lean/Six Sigma methodologies.
 
 
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 Maintain inspection readiness and contribute to regulatory inspection support.
 
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 In depth understanding of S&amp;OP, production planning and materials management processes
 
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 An ability to build strong partnerships and effectively integrate with external collaborators to drive projects/programs forward in a matrixed environment
 
 
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 Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
 
 
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 Knowledge of cGMP regulations and FDA guidance related to manufacturing of cell based products.
 
 
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 Ability to promote a mindset of continuous improvement, problem solving, and prevention (Lean/Six Sigma and ASCM certifications preferred).
 
 
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 Strong analytical, problem solving and critical thinking skills
 
 
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 Excellent organizational and communication skills
 
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 Transparent, Passionate, Fearless and Accountable
 
 
 
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 Requirements
 
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 Bachelor&rsquo;s degree in Supply Chain Management, Business/Engineering, or related field or equivalent work experience required.
 
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 A minimum of 8 years working within supply chain/operations.
 
 
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 Operations experience within a cGMP environment in the biotech/biopharma industry preferred SAP and/or Oracle.
 
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 Technologically savvy with the ability to quickly adopt new systems and processes. Proficient in Excel (Pivot Tables and Advanced Analytics), Power BI/Tableau, Word, Visio.
 
 
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 Hands on experience with ERP/MRP systems (SAP S4 Hana, Anaplan, Kinaxis Rapid Response, Binocs preferred) and advanced planning tools.
 
 
 
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 The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.&nbsp;Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.&nbsp;Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&amp;D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
 
 
 Pay Range (Base Pay): : $142,146 USD - $186,567 USD
 
 
 
 
 
 Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech.
 
 
 
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 EEO Statement
 
 
 
 
 It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
 
 
 
 &nbsp;
 
 
 
 Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.
 
 
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 For information related to our privacy policy, please review:&nbsp;Legend Biotech Privacy Policy.
 
</div>

AD, Site Supply Chain

Join Legend Biotech and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Legend Biotech

About Company

Operations Specialist

AD, Site Supply Chain