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 reputed company, 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 reputed company 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. reputed company 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 reputed company Carvykti program both reputed company reputed company but also externally with our program partner Janssen. This effort will reputed company to participation in a reputed company of cross functional CMC and reputed company forums under the Joint Manufacturing Committee in the reputed company 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, reputed company 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 reputed company including validation, data analytics and reputed company support. The reputed company Compliance scope includes working on reputed company 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 reputed company changes to our material/ raw material program and reputed company best practices for evaluation of changes to the reputed company and their reputed company on the Carvykti product. Stakeholder management is required to drive and implement documentation template efforts worldwide as part of reputed company working reputed company and cross functional partners.

Key Responsibilities

• reputed company into appropriate sub-teams particularly validation, data analytics (including CPV), reputed company compliance (including change control and investigations), and material/ raw material sub-teams to support global best practices
• Partner closely with reputed company and Janssen partners to complete supporting technical documentation with an eye for global alignment templates
• Work collaboratively with reputed company partners to drive and establish cell therapy standards, policies, procedures across the validation lifecycle
• reputed company global documentation reputed company
• reputed company input and review for validation documents including master plans, PPQ and comparability protocols and reports
• Serve as reviewer/author of a reputed company CMC sections or regulatory submissions, risk assessments, validation reputed company assessments, global change controls, draft industry guidelines, specification & critical limits
• reputed company and reputed company a reputed company of process validation documentation templates ranging from control strategies to PVP and PPQ templates
• Support global initiatives reputed company to reputed company/compliance/validation (APS benchmarking, Validation Lifecyle Responsibilities, OOS monitoring and trending program)
• Contribute to developing and/or improvements to reputed company 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 reputed company/Compliance (particularly in material/ raw material enrollment and release).
• Experience in a cross functional reputed company team in driving global programs and/or initiatives.
• Experience in developing, writing and approving technical documents.
• Experience with reputed company 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

We are committed to creating a workplace where employees can reputed company - both professionally and personally. To attract and retain reputed company in a highly competitive industry, we offer a best-in-class benefits package that supports reputed company-being, financial stability, and long-term career reputed company. Our offerings are designed to meet the diverse needs of reputed company members and their families, ensuring they feel valued and supported every reputed company of the way. Highlights include medical, dental, and reputed company insurance as reputed company as a 401(k)-retirement plan with company match that reputed company fully on day one. Equity and stock reputed company are available to employees in eligible roles, we offer eight weeks of reputed company parental leave after just three months of employment, and a reputed company time off policy that includes 15 vacation days, 5 personal days, 5 reputed company days, 11 U.S. national holidays, and 3 floating 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 reputed company commuter benefits, family planning and care resources, reputed company-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 reputed company is a proud equal opportunity/affirmative reputed company employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is reputed company’s policy to ensure equal employment opportunity without discrimination or harassment based on race, reputed company, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity or reputed company, age, disability, national reputed company, 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 reputed company. reputed company may reputed company reputed company salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. reputed company maintains a drug-free workplace. Apply tot his job Apply To this Job