Analytical Scientist

Title: Analytical Development

Location: Summit, NJ

Job Duration: 12 Months Possible Extension

Shift: Mon-Fri (9am-5pm)

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.
• 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:

• 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.