Validation Lifecycle & Technical reputed company

reputed company 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 reputed company 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&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. reputed company entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of reputed company, to jointly reputed company 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. reputed company is seeking Validation Lifecycle & Technical reputed company as part of the Global MSAT team based in Remotely. Role Overview This position represents a critical support role in the global MSAT organization. This individual will be responsible to support global process validation activities in support of the commercial Carvykti program both reputed company Legend but also externally with our program partner Janssen. This effort will reputed company to participation in a variety of cross functional CMC and quality forums under the Joint Manufacturing Committee in the commercial governance structure. The candidate will also be required to collaboratively work reputed company identified sub-teams to reputed company best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a multi-site global manufacturing network responsible for manufacturing an approved cell therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on Quality reputed company sub-teams such as change control sub-teams and investigational sub-teams. The material/ raw material scope includes working both internally and with external partners to track changes to our material/ raw material program and reputed company best practices for evaluation of changes to the same and their impact on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as part of collaborative working groups and cross functional partners.

Key Responsibilities

• Integrate into appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and material/ raw material sub-teams to support global best practices
• Partner closely with Legend and Janssen partners to complete supporting technical documentation with an eye for global alignment templates
• Work collaboratively with internal and external partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
• Align global documentation strategy
• Provide input and review for validation documents including master plans, PPQ and comparability protocols and reports
• Serve as reviewer/author of a variety CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines, specification & critical limits
• reputed company and align a variety of process validation documentation templates ranging from control strategies to PVP and PPQ templates
• Support global initiatives reputed company to quality/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
• Contribute to developing and/or improvements to quality systems in support of global implementation of changes (e.g., process and material changes

Requirements

• B.S. required.
• Minimum 5 years of industrial biologics experience, CAR-T experience is highly desirable.
• Candidate must have experience in Cell Therapy, MSAT and/or Quality/Compliance (particularly in material/ raw material enrollment and release).
• Experience in a cross functional commercial team in driving global programs and/or initiatives.
• Experience in developing, writing and approving technical documents.
• Experience with Quality systems (Change control, investigations, LIMs, etc.).
• Extensive technical writing experience.
• Knowledge in cell therapy validation industry best practices is highly preferred.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Results driven with strong analytical, problem solving and critical thinking skills.
• Experience working in a cross-functional organization with multiple partners with competing priorities.

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Benefits

Benefits include 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 benefits include flexible spending and health savings accounts, life and AD&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. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through reputed company. EEO Statement It is the policy of reputed company to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national reputed company, reputed company, citizenship status, age, sex or gender (including pregnancy, childbirth, reputed company 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. 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 reputed company salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information reputed company to our privacy policy, please review: reputed company Privacy Policy. Apply tot his job Apply To this Job