7731 Research Assistant
Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
The Analytical Sciences department, a part of Process Sciences within Tech Ops, supports all assay needs in Tech Ops.
Our scientists and associates are experts in analytics of gene therapy agents, small molecules, peptides, complex glycosylated enzymes and PEGylated proteins.
We develop and qualify assays to follow the quality attributes of our products, support IND and BLA applications, assess the capability of our processes by analyzing in-process samples all the way from bioreactors through purification steps to the drug substance and develop release assays for transfer to Quality.
We are also instrumental in time-critical analysis support to Manufacturing as needed.
The Analytical Sciences department is seeking a skilled Analytical Biochemist and/or Biologist at the Research Associate level to join a team focused on supporting gene therapy & enzyme replacement therapy.
The successful candidate will be a self-motivated, independent and critical thinker who has experience to work in a multi-disciplinary and fast-paced environment, and solid communication skills.
The candidate will develop and execute a wide variety of analytical methods and assays for the characterization of therapeutic candidates in development with a particular focus on critical program needs including CMC development for INDs and BLAs.
An ideal candidate will have experience in cell-based assays.
The candidate will be responsible for providing support to the on-time release, stability and non-routine testing of the pharmaceutical drug substances and drug product in a cGMP environment.
The candidate will provide support to activities related to sample and/or lab equipment management.
Adhere and follow cGMPs guidelines and procedures.
Escalate non-compliance concerns to management.
Monitor lab equipment for calibration needs, monitoring and tracking of issues related to instrumentation.
Perform Analytical testing including: cell-based assays, cell culturing/maintenance, ELISAs, etc.
Assist with preparation of protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies.
Assist in planning and execution of relevant experiments to support development and qualification of analytical assays for gene therapy agents and biologics to meet project goals and timelines.
Report progress to the manager on a weekly basis on each program.
Other duties as assigned
Skills: Required Skills:
Basic level of lab testing and cell culture techniques.
Excellent communication, collaboration and writing skills.
Proven data analysis, interpretation and scientific communication skills.
Proven flexibility and execution skills to deliver in a fast-paced, multi-tasking environment.
0-2 years of experience Bioanalytical assays.
Knowledge of biopharmaceutical development is a plus
Bachelor’s degree in scientific discipline or equivalent.