Legend Biotech USA
Job Description Summary
The Cell Management Specialist plays a pivotal role in ensuring seamless operations across critical stages of the process. From managing Apheresis Receipt and overseeing Day 0 and Harvest transfers, to coordinating Final Product Packaging and maintaining precise inventory control, this role is central to supporting the core functions that drive success.
Job Description Location: Morris Plains, NJ
This role is based in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities
Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time Performance
Ensure prompt and precise data entry
Maintain compliance with training requirements
Keep Manufacturing Support areas in an audit ready state
Provide flow to the work support when needed/available
Perform equipment cleaning and maintenance in accordance with governing SOP requirements
Escalate and help reconcile any observed compliance or safety issues
Be proficient in various operating systems, such as LIMS, SAP, and MES
Support monthly and annual cycle counts
Participate in site/team projects and initiatives
Act according to Novartis Values and Behaviors
Ensure accurate SAP/MES inventories for all components
Properly segregate and store all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities
Receive and inspect incoming leukapheresis
Package and ship final products
Deliver scheduled Day 0 apheresis for patient processing on time
The Harvest and storage of final product
Receive and store final products from scheduled patient processing
Resolve outstanding issues with internal and external customers through follow-up communicationCoordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
Verify inventory accuracy of GMP and non-GMP LN2 storage locations
Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities
Role Requirements
1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
High School diploma required; Bachelor's degree preferred.
Strong interpersonal, written, and communication skills, along with problem-solving and follow-up abilities.
Must be well organized, flexible, and able to work with minimal supervision.
Ability to lift up to 50 lbs., assisted.
Requires handling chemicals such as corrosives, solvents, and bio-hazardous material.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $52,400 and $97,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Company will not sponsor visas for this position.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range $52,400.00 - $97,400.00
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Job Description Location: Morris Plains, NJ
This role is based in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Key Responsibilities
Follow all area governing SOPs, WPs, and batch records with an emphasis on Right First-Time Performance
Ensure prompt and precise data entry
Maintain compliance with training requirements
Keep Manufacturing Support areas in an audit ready state
Provide flow to the work support when needed/available
Perform equipment cleaning and maintenance in accordance with governing SOP requirements
Escalate and help reconcile any observed compliance or safety issues
Be proficient in various operating systems, such as LIMS, SAP, and MES
Support monthly and annual cycle counts
Participate in site/team projects and initiatives
Act according to Novartis Values and Behaviors
Ensure accurate SAP/MES inventories for all components
Properly segregate and store all conditioned materials
APH Receipt / Final Pack / Day 0 / Harvest Activities
Receive and inspect incoming leukapheresis
Package and ship final products
Deliver scheduled Day 0 apheresis for patient processing on time
The Harvest and storage of final product
Receive and store final products from scheduled patient processing
Resolve outstanding issues with internal and external customers through follow-up communicationCoordinate the shipping, receiving, storage, and processing of goods, possibly including imports/exports
Verify inventory accuracy of GMP and non-GMP LN2 storage locations
Ensure availability and accuracy of all materials and documentation to avoid impediments to daily activities
Role Requirements
1-3 years of related experience in a cGMP/FDA regulated industry; warehouse experience preferred.
High School diploma required; Bachelor's degree preferred.
Strong interpersonal, written, and communication skills, along with problem-solving and follow-up abilities.
Must be well organized, flexible, and able to work with minimal supervision.
Ability to lift up to 50 lbs., assisted.
Requires handling chemicals such as corrosives, solvents, and bio-hazardous material.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $52,400 and $97,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Company will not sponsor visas for this position.
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range $52,400.00 - $97,400.00
#J-18808-Ljbffr