Job Title: Analyst – Analytical Testing
Location: Summit, NJ
Duration: 6 Months
No. of Positions: 1
Visa Status: US Citizen / Green Card
JOB DESCRIPTION: 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 organizational 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 grou p 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 a bili ty to communicate effectively with peers, department management and cross-functional peers.
EDUCATION AND EXPERIENCE:B.S. with 4+ years’ work experience or M.S. with 2+ 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 execution 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.
