Current jobs related to Senior Validation Lead - Plainsboro Center, New Jersey - Genmab
-
Memory Care Assistant
4 weeks ago
Plainsboro, New Jersey, United States Maplewood Senior Full timeJob Title: Memory Care AssistantMaplewood Senior Living is seeking a compassionate and dedicated Memory Care Assistant to join our team. As a Memory Care Assistant, you will play a vital role in providing exceptional care and support to our residents with memory impairments.Responsibilities:Provide outstanding customer service to residents, family members,...
-
Plainsboro, New Jersey, United States Genmab Full timeJob OverviewGenmab is seeking an experienced Associate Director to lead the development and implementation of advanced validation strategies for computer software assurance and validation. This role will be responsible for elevating our validation processes using cutting-edge technologies such as Generative AI, unscripted testing, and automation.Key...
-
Senior Facility Automation Specialist
4 weeks ago
Plainsboro, New Jersey, United States Integra LifeSciences Full timeJob SummaryThe Senior Facility Automation Specialist will be responsible for the firmware, logic, code generation, documentation, backups, troubleshooting, and optimization of automated systems in use at the Product Development and GMP manufacturing areas of the Collagen Manufacturing Center (CMC).Inclusive in this role are WFI, CCA, PS, and other utilities...
-
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleWe are seeking an experienced Associate Director to lead our validation processes using advanced technologies such as Generative AI (GenAI), unscripted testing, and automation. This role is crucial for maintaining the highest standards of quality and compliance, adhering to key regulatory guidelines from relevant authorities.Key...
-
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeJob Summary:We are seeking a highly skilled Digital Transformation Strategist to join our Commercial Excellence team. The ideal candidate will have a strong background in data-driven commercial strategy and experience in leading digital transformation initiatives.Key Responsibilities:Develop and execute digitization roadmaps for HCPs and patients, ensuring...
-
Senior Frontend Architect
1 month ago
Plainsboro, New Jersey, United States Omni Inclusive Full timeJob DescriptionWe are seeking a highly skilled Senior Frontend Architect to lead our frontend development team. The ideal candidate will have a strong background in frontend development, with expertise in component-driven architectures and a proven track record of delivering high-quality applications.The Senior Frontend Architect will be responsible...
-
Therapeutic Area Operations Lead
4 weeks ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeAbout the RoleThe Therapeutic Area Operations Lead will play a key role in supporting the development of a One Impact Planning strategy to optimize the therapeutic area product portfolio, aligning with the overarching corporate goals and market dynamics.This role will oversee and manage all therapeutic area-specific business operations processes to ensure...
-
Senior Manager
4 weeks ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Manager to lead our digital procurement solutions team. The ideal candidate will have a strong background in procurement, digital transformation, and change management.Key ResponsibilitiesDevelop and implement digital procurement strategies to drive business growth and efficiencyLead the implementation of...
-
Senior Business Development Manager
1 month ago
Plainsboro, New Jersey, United States WuXi AppTec Full timeJob SummaryWe are seeking a highly motivated and experienced Senior Business Development Manager to join our team at Wuxi AppTec. As a key member of our commercial team, you will be responsible for driving the company's continued growth and carrying the sales targets for our Laboratory Testing Division.Key Responsibilities:Source, close, and support IND and...
-
Senior Manager
1 month ago
Plainsboro, New Jersey, United States Novo Nordisk Full timeJob SummaryThe Senior Manager - Strategic Pricing and Contracting will be responsible for supporting and optimizing approved strategies across Commercial and Medicare channels and customers with the designated SPC Account Lead. This individual will also identify current market trends or signals that may call for reevaluation of our strategic direction.Key...
-
Senior Procurement Specialist
4 weeks ago
Plainsboro, New Jersey, United States Integra LifeSciences Full timeJob SummaryIntegra LifeSciences is seeking a skilled Senior Procurement Specialist to join our team. As a key member of our procurement team, you will be responsible for managing suppliers, purchase orders, and inventory to meet schedule and plant objectives.Key ResponsibilitiesManage daily supplier interactions, purchase orders, and inventory to meet...
-
AEM Front End Lead Developer
4 weeks ago
Plainsboro, New Jersey, United States Cognizant North America Full timeAEM Front End Lead DeveloperWe are seeking a highly skilled AEM Frontend Lead Developer with 10 to 13 years of experience to join our team. The ideal candidate will have extensive experience in AEM support system engineering frontend backend and authoring. A background in bioinformatics is a plus. This role will involve managing projects that leverage AEM...
-
Intelligent Automation Senior Manager
4 weeks ago
Plainsboro, New Jersey, United States PERMEVO Full timeJob Title: Senior Manager of Intelligent Automation SolutionsJob Location: Princeton (Must be able to be on-site 60% of the time)Job Duration: Permanent (Hybrid Role)The Challenge:We are seeking an innovation-focused Senior Software Engineer specializing in Intelligent Automation, AI, and Software Development to join our IT Commercialization & Enabling...
-
Continuous Improvement Engineer I
4 weeks ago
Plainsboro, New Jersey, United States Integra LifeSciences Full timeJob SummaryIntegra LifeSciences is seeking a highly skilled Continuous Improvement Engineer I to join our team. As a key member of our organization, you will play a crucial role in driving and facilitating process improvement initiatives across the company.Key ResponsibilitiesLead and execute high-impact continuous improvement projects.Develop and implement...
-
Senior AI Engineer
4 weeks ago
Plainsboro, New Jersey, United States Codebase Inc Full timeAI Solutions DeveloperLocation: RemoteJob Description:At Codebase Inc, we're seeking a skilled AI Solutions Developer to design and build generative AI solutions using Snowflake GenAI, OpenAI, and other advanced AI platforms. This role involves developing and fine-tuning models for natural language processing (NLP), machine learning (ML), and deep learning...
-
Speech Therapist
2 weeks ago
Plainsboro, New Jersey, United States Fox Rehabilitation Full timeAbout UsAt Fox Rehabilitation, we are dedicated to providing exceptional care to our patients. Our team of full-time physical, occupational, and speech therapists work together to deliver personalized treatment plans tailored to each patient's needs.Our ApproachWe believe in empowering our patients to achieve their goals through one-on-one care and...
-
Senior Programming Associate
1 month ago
Plainsboro, New Jersey, United States Genmab Full timeAbout the RoleAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science,...
-
Senior Director of Hemophilia Therapy Area
4 weeks ago
Plainsboro, New Jersey, United States BioSpace, Inc. Full timeAbout the PositionThe Associate Director, HCP Experience has overall strategic and operational responsibility as well as tactical pull through of all efforts for Health Care Providers within their designated Hemophilia Therapy Area and for relevant in-line and new product commercialization assets (3 years prior to launch).Key ResponsibilitiesLead the...
-
Senior Ambulatory Care Nurse
1 month ago
Plainsboro, New Jersey, United States GHR Healthcare Full timeGHR Healthcare is seeking a skilled contract nurse for an ambulatory care position in a local setting.Job Description & RequirementsSpecialty: Ambulatory CareDiscipline: NursingJob Type: ContractShift: 8 hours, daysDuration: 13 weeksHours: 40 hours per weekAbout GHR HealthcareWe are a leading healthcare staffing agency dedicated to connecting healthcare...
-
Senior Financial Reporting Manager
4 weeks ago
Plainsboro, New Jersey, United States Ambassador Resources Full timeAmbassador Resources is a boutique search firm based in the US.We specialize in direct hire and consulting solutions and partner with organizations across various industries.Our areas of expertise include Accounting & Finance, Supply Chain & Procurement, and Human Resources & Administrative positions.The client is a global biotechnology company located in...
Senior Validation Lead
1 month ago
We are seeking an experienced Senior Validation Lead to join our team at Genmab. As a key member of our IT & Digital department, you will be responsible for elevating our validation processes using advanced technologies such as Generative AI (GenAI), unscripted testing, and automation.
Key Responsibilities- Develop and implement validation strategies incorporating GenAI to streamline validation processes.
- Design and execute validation protocols and standards (IQ/OQ/PQ) for new and existing equipment and systems.
- Define the systems/toolsets needed to maintain validated state of our digital products and platforms, while operating in an agile and product-based delivery model.
- Utilize unscripted testing and risk-based validation methods to ensure compliance and efficiency.
- Implement and maintain automated validation solutions to enhance process efficiency.
- Apply the FDA's new CSA guidelines to reduce documentation burdens while maintaining product quality and safety.
- Compile and analyze validation data using advanced data analytics and machine learning techniques.
- Prepare comprehensive validation reports and make recommendations for process improvements.
- 10 years of proven experience in validation and software assurance/QA within the pharmaceutical or biotech industry.
- Strong track record in implementing advanced validation methods and automation.
- Experienced in managing GxP systems, DevSecOps, Agile methodologies, operating within the Atlassian suite, and a product-based delivery model.
- Proficiency in utilizing GenAI and other AI tools for validation processes.
- Strong understanding of unscripted testing, risk-based validation, and CSA methodologies.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
