The Analytical Development Analyst is responsible for in-process and release sample testing, for Manufacturing upstream and downstream as well as process development studies. Performs analytical methods such as cell-based assays, PCR based assays, protein determination, SDS-PAGE, Western Blot, ELISA, and compendial testing.

Responsibilities:

• Perform Analytical Development Laboratory testing accurately and to schedule as per written procedures. Record all data, observations, and QC results accurately with keen attention to detail onto controlled records to cGMP standards.
• Exhibit good aseptic technique while preparing reagents, performing routine maintenance of cell cultures, and performing cell-based assays.
• Perform routine cell culture and cell banking (research and analytical cell banks)to support cell-based assay program.
• Perform analytical methods such as cell-based assays (Plaque, TCID50), PCR based assays (Traditional PCR, qPCR, and dPCR), ELISAs, Compendial testing (pH, Endotoxin, etc.), SDS-PAGE, and Western Blot.
• Compile and summarize test data and perform data analysis.
• Coordinate with other functional groups to support upstream and downstream process development testing to meet corporate objectives.
• Write, review, and edit SOPs and Test Methods for new procedures and assays; review, edit and revise existing SOPs to reflect changes in procedures.
• Responsible for following Good Documentation Practices (GDP) and ensuring adherence to current Good Manufacturing Practices (cGMP) compliance, and any other local, state, and federal regulations associated with the release of investigational and pharmaceutical drug products.
• Communicate matters of importance such as plans, technical problems, results etc. to the manager/supervisor and to other scientific personnel associated with the study, which may impact successful completion of projects.
• Ensures that all laboratory equipment is monitored for adherence to performance parameters on a scheduled basis and is operating within requirements. Immediately reports any equipment failures to management.
• Ordering new supplies and reagents to ensure sure that we do not run out of important reagents.
• Other duties as assigned.

Qualification and educational requirement:

• Bachelor’s degree
• A minimum of 3-4 years with hands-on experience with cell culture and cell based viral assays
• A minimum of 3-4 years related experience with biological products, in a GMP Quality Control laboratory.
• Must have strong experience in the development and performance of Cell based assays and PCR based assays (TCID50, Plaque, Traditional PCR, qPCR, etc.)
• Experience with spectrophotometric methods, ELISAs, SDS-PAGE, Western Blot, a plus.
• Must have experience with cGMP and quality systems including OOS investigations, deviations, change control and CAPAs.
• Requires excellent written and oral communication skills.
• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
• Proven and demonstrated computer (PC) and software skills including MS Office Suite programs.
• Position requires work with BSL2 pathogens including live and attenuated virus. Must be willing to comply with CDC recommendations including vaccinations.
• High attention to detail, excellent organizational skills and the ability to work on multiple projects with tight deadlines.
• Great interpersonal skills
• Strong communication
• Takes initiative
• Remains calm under pressure

Job Type: Full-time

Pay: From $75,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Work Location: In person