The Analytical Development Scientist is responsible for in-process sample testing, for Manufacturing upstream and downstream as well as process development studies. Develops, plans, and performs analytical methods, (such as PCR based assays, protein determination, SDS-PAGE, Western Blot, ELISA, Endotoxin, and cell-based assays)
location: Rockville, Maryland
job type: Contract
salary: $45 - 50 per hour
work hours: 9 to 5
- Perform Analytical Development Laboratory testing accurately, record all data, observations, and QC results accurately. Provide scientific input and demonstrate critical thinking in experimental design and execution.
- Perform analytical methods such as PCR-based assays (Traditional PCR, qPCR), protein determination by A 280, Bradford, and BCA, SDS-PAGE, Western Blot, ELISA, Endotoxin.
- Maintain cell cultures and generate analytical cell banks.
- Perform cell-based assays (TCID 50 , Plaque) as needed.
- Troubleshoot methods, compile, review and submit accurate reports. Compile and summarize test data and perform data analysis. Write essays, technical development reports and give oral presentations of data at internal or external meetings.
- Coordinate with other functional groups to support upstream and downstream, process development studies 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.
- Order and maintain laboratory reagents and supplies.
- 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 the 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 making sure that we do not run out of important reagents.
- Other duties as assigned
- Bachelor's degree
- A minimum of 4-6 years of laboratory experience
- Must possess a basic knowledge of molecular biology, virology, and cell biology techniques such as experience using real-time PCR, or performing various molecular assays.
- Must have strong experience in the development and performance of Cell-based assays and PCR-based assays (TCID 50 , Plaque, Traditional PCR, qPCR, etc.)
- Hands-on experience with non-cell-based analytical assays, including but not limited to: protein determination, SDS-PAGE, Western Blot, ELISA, pH, Endotoxin.
- Knowledge of cell culture and cell-based assays (TCID 50 , Plaque).
- Experience with the development and validation of assays used for the characterization of biological products (protein, antibody, VLP, AAV, live virus, etc).
- High attention to detail, excellent organizational skills, and the ability to work on multiple projects with tight deadlines.
- Demonstrated ability to work independently as well as a strong contributor in a cross-functional team environment on complex projects. Able to work effectively alone and in teams.
- Able to prioritize and demonstrate flexibility in schedule (late shift) as demanded by project needs or management.
- Requires excellent written and oral communication skills. Proven and demonstrated computer (PC) and software skills including MS Word, Excel, and PowerPoint are required.
- Willingness to cross-train as needed
- Great interpersonal skills
- Strong communication
- Takes initiative
- Remains calm under pressure
skills: Molecular Biology, Cell Biology, PCR
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.