BioSpace
Scientist II, Analytical Development
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Legend Biotech
Location:
Somerset, NJ
Join our Analytical Development organization as a Scientist II focused on Flow Cytometry and Functional Assays. Your work will support product release, characterization, and stability assessment for cell therapy products.
Role Overview Develop, optimize, and qualify flow cytometry-based methods, cell‑based potency assays, and other bioanalytical strategies. Work closely with QC and Manufacturing teams to ensure seamless assay execution and continuous improvement.
Key Responsibilities
Develop and optimize assays, including potency (cell‑based), flow cytometry, and ELISA assays.
Lead tech transfer of methods to QC and manage assay execution.
Pre‑qualify and qualify assays, identifying critical parameters and developing critical materials such as cell banks.
Generate SOPs and laboratory protocols for assay support.
Collaborate cross‑functionally with QC and Manufacturing for troubleshooting and continuous improvement.
Present scientific data and trends at internal and external forums.
Maintain proper documentation in ELN, test method development plans, reports, and equipment logs.
Manage multiple concurrent projects, meeting timelines while maintaining data integrity.
Make decisions related to assay development runs and weekly work priorities, with approvals for major changes.
Requirements
PhD or Master’s in a scientific discipline, or equivalent engineering background.
2–5 years of related experience in analytical method development and qualification.
Expertise in multicolor flow cytometry, cell culture, potency assays, cytotoxicity assays, cytokine release assays, immunoassays, and infectious titer assays.
Independent judgment in developing methods and evaluation criteria.
Strong understanding of ICH guidelines and regulatory expectations for method qualification.
Ability to author SOPs and procedures.
Detail‑oriented problem‑solving and decision‑making skills.
Excellent presentation, scientific writing, and communication skills.
Proficiency with Excel, Word, PowerPoint, GraphPad Prism, and flow‑cytometry analysis software (e.g., FlowJo, CytExpert).
Experience with ELN systems such as LabVantage.
Compensation Base pay range: $107,482 – $141,070 USD
Benefits Legend Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company match, equity and stock options, paid parental leave, paid time off, flexible spending accounts, life and disability insurance, and additional well‑being programs.
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to a diverse and inclusive workforce. Employment is at‑will, and we maintain a drug‑free workplace.
#J-18808-Ljbffr
–
Legend Biotech
Location:
Somerset, NJ
Join our Analytical Development organization as a Scientist II focused on Flow Cytometry and Functional Assays. Your work will support product release, characterization, and stability assessment for cell therapy products.
Role Overview Develop, optimize, and qualify flow cytometry-based methods, cell‑based potency assays, and other bioanalytical strategies. Work closely with QC and Manufacturing teams to ensure seamless assay execution and continuous improvement.
Key Responsibilities
Develop and optimize assays, including potency (cell‑based), flow cytometry, and ELISA assays.
Lead tech transfer of methods to QC and manage assay execution.
Pre‑qualify and qualify assays, identifying critical parameters and developing critical materials such as cell banks.
Generate SOPs and laboratory protocols for assay support.
Collaborate cross‑functionally with QC and Manufacturing for troubleshooting and continuous improvement.
Present scientific data and trends at internal and external forums.
Maintain proper documentation in ELN, test method development plans, reports, and equipment logs.
Manage multiple concurrent projects, meeting timelines while maintaining data integrity.
Make decisions related to assay development runs and weekly work priorities, with approvals for major changes.
Requirements
PhD or Master’s in a scientific discipline, or equivalent engineering background.
2–5 years of related experience in analytical method development and qualification.
Expertise in multicolor flow cytometry, cell culture, potency assays, cytotoxicity assays, cytokine release assays, immunoassays, and infectious titer assays.
Independent judgment in developing methods and evaluation criteria.
Strong understanding of ICH guidelines and regulatory expectations for method qualification.
Ability to author SOPs and procedures.
Detail‑oriented problem‑solving and decision‑making skills.
Excellent presentation, scientific writing, and communication skills.
Proficiency with Excel, Word, PowerPoint, GraphPad Prism, and flow‑cytometry analysis software (e.g., FlowJo, CytExpert).
Experience with ELN systems such as LabVantage.
Compensation Base pay range: $107,482 – $141,070 USD
Benefits Legend Biotech offers a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company match, equity and stock options, paid parental leave, paid time off, flexible spending accounts, life and disability insurance, and additional well‑being programs.
EEO Statement Legend Biotech is a proud equal opportunity/affirmative action employer committed to a diverse and inclusive workforce. Employment is at‑will, and we maintain a drug‑free workplace.
#J-18808-Ljbffr