Global Product Development and Supply - Cell Therapy Analytical Development (CTAD)

Mindlance

Summit, NJ

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JOB DETAILS

SKILLS

Analysis Skills, Analytical Development, Assay Development, Assays, Biotech and Pharmaceutical, Cell Analysis, Cell Cultures, Communication Skills, Continuous Improvement, Corrective Action, Cross-Functional, Data Analysis, Drug Products, Drug Therapy, Equipment Maintenance/Repair, Establish Priorities, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Identify Issues, Immunology, Laboratory Equipment, Molecular Biology, Multitasking, Organizational Skills, Polymerase Chain Reaction (PCR), Presentation/Verbal Skills, Problem Solving Skills, Product Development, Quality Assurance Methodology, Quality Control, Real-time PCR (qPCR), Regulations, Scientific Principles, Team Player, Technical Operations, Test Data, Testing, Time Management, Willing to Travel, Writing Skills

LOCATION

Summit, NJ

POSTED

18 days ago

Global Product Development and Supply - Cell Therapy Analytical Development (CTAD)
100% onsite
Work Schedule: Mon-Fri(9am-5pm)

Work Location will be Summit West but need to be flexible to travel to Warren Liberty Corner location as needed.

PURPOSE AND SCOPE OF POSITION:
The Analyst is responsible for supporting the method transfer and analytical testing with moderate supervision as part of Cell Therapy Technical Operations (CTTO) Team. The analytical department is responsible for flow cytometry, cell-based potency, RT-qPCR/PCR and other analytical assays testing to support process characterization testing of the lentiviral vector and cell therapy drug product samples. This includes the ability to interface with multiple groups, independently perform tasks, interpret results, and troubleshoot.

REQUIRED COMPETENCIES (Knowledge, Skills, and Abilities):
" Advanced hands-on experience with various analytical techniques including flow-cytometry, molecular techniques
" Scientific knowledge in the characterization and transfer of pharmaceutical products.
" Experience with PCR and/or flow cytometry and/or mammalian cell culture is required.
" Experience working in a regulated (GLP/GMP) environment in preferred.
" Assay development, especially cell-based potency assays are preferred.
" Assay qualification/validation experience is preferred.
" Assay Technology Transfer (TT) experience is preferred.
" Excellent organization skills and ability to handle multiple tasks
" Highly motivated, willingness to acquire new skills, and ability to work with minimal supervision.
" Excellent verbal and written communication skills.
" Advanced problem-solving ability/mentality, technically adept and logical thinking.
" Ability to represent the interests of the group on cross-functional teams.
" Ability to work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects.
" Ability to work with management locally and globally.
" Advanced ability to communicate effectively with peers, department management and cross-functional peers.

EDUCATION AND EXPERIENCE:
" Required B.S. with 2+ years work experience or M.S. with 0 years experience in Molecular & Cellular Biology, Immunology, or related discipline.

DUTIES AND RESPONSIBILITIES:
" 100% onsite required.
" Perform experiments using the following methodologies: PCR, RT-qPCR, flow cytometry, mammalian cell culture, Luminex, MSD, and ELISA.
" With moderate supervision design and execute analytical experiments of moderate complexity.
" Perform data analysis, summarize and report experimental results.
" Document/review laboratory work in notebooks that is detailed, accurate, timely, and in compliance with Good Lab Practices/Good Documentation Practices requirements.
" Collaborate with the Quality Control and Analytical Development teams to advance analytical and development projects.
" Ensure proper operation and perform routine maintenance of all laboratory equipment.
" Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
" Perform cell based in-vitro flow experiment, ELISA, qPCR to assess critical reagent concentration.
" Capable of handling complex issues and solving problems with only general guidance.
" Prepare and present continuous improvement projects to management.
" Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
" Complete all work in a timely manner. Perform peer review of testing data.
" Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
" Complete all reviews in accordance with required timelines.
" Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
" Participate in complex projects and continuous improvement efforts.
" Communicate effectively with management regarding task completion, roadblocks, and resource needs.
" Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.

EEO:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

About the Company

Mindlance

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