Job OverviewAssist in the development and execution of methods related to the testing and characterization of biotherapeutics using analytical instrumentation and methodologies. Under minimal supervision, may be responsible for method feasibility, method development, method optimization, method transfers, method qualifications, method validations and routine testing under both R&D and cGMP environments. Additionally, will be responsible for client interaction, interpretation and reporting of data of assigned research projects
Job DescriptionESSENTIAL DUTIES AND RESPONSIBILITIES: - Perform and troubleshoot laboratory experiements, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through use of analytical testing and characterization and instrumentation and methodologies.
- Perform routine testing techniques, such as the following, with a high degree of reliability, efficiency and accuracy:
o Chromatographic Analyses including Process Related Residuals
o Quantitative Monosaccharide and Sialic Acid Analysis
o ELISA/ Immunoassay Analyses
o Process Residual/Drug Product Excipient Analyses
o N- Terminal Sequencing
o Amino Acid Compositional Analysis/Extinction Coefficient Determination
o Use of Empower and Chromelion Software - Review, interpret, analyze, evaluate, integrate and present experimental data with minimal assistance of senior technical staff as appropriate.
- Perform tabulation and statistical analyses of study data, as required.
- Prepare high quality final reports appropriate for assigned study, including integration of supporting subcontractor(s)'s reports into final reports as required, with assistance from Senior personnel.
- Assist in the technical review of procedures and data and documentation.
- Assist in long-term projects (redesign of SOPs, CTMs, basic research procedures or report formats).
- Interact with clients regarding project design, scheduling and conduct as requested.
- Collaborate with appropriate departments to coordinate performance of projects, discuss issues and prepare reports.
- Attend scientific meetings, conferences and training courses to enhance job and professional skills.
- For both cGMP and R&D grade routine testing, generate analytical data and technical report(s) on-time with respect to internal and client deadlines. Maintain a weekly schedule to ensure all timelines are met.
- Actively participate in laboratory instrumentation and equipment preventative maintenance and qualification programs.
- Maintain a safe working environment by adhering to Company policies or procedures. Actively participate in laboratory maintenance.
- Comply with all pertinent regulatory standards regarding environs, equipment and testing services.
- Perform equipment troubleshooting and repair (as applicable) with minimal guidance from senior members of the group.
- Make detailed observations and maintain clear, accurate and timely documentation.
- Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
- Assist in training and provide technical support of Junior staff.
- Participate in transferring and training of analytical technical staff on methodology for which qualification has been successfully completed.
- Maintain up to date training records on all procedures and protocols applicable to work duties.
- Ability to work in a structured and regulated environment.
- Work productively in group situations as well as independently.
- Perform all other related duties as required.
QUALIFICATIONS: - Education: Bachelor's degree (B.A. /B.S.) or equivalent in Chemistry/Biotechnology or related scientific discipline. M.S. or Ph.D. preferred.
- Experience: Minimum 3 year's relevant experience within a contract research, academic or pharmaceutical industry, including experience in the core competencies of characterization and analysis of biotherapeutics.
- An equivalent combination of education and experience with contract research or the pharmaceutical industry may be accepted as a satisfactory substitute for the specific education and experience listed above.
Compensation DataThe pay rate for this role is $98,000 - $106,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
