Job Summary

Perform routine biophysical methods independently as specified in standard in-house SOPs, Client Test Methods, and other written procedures.  Under direct supervision, perform method development work as assigned.

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

•    Independently perform laboratory activities including but not limited to reagent preparation, laboratory cleaning, maintenance/monitoring of laboratory equipment, routine testing of client samples, and generation of routine cGMP and R&D reports
•    Develop understanding of processes and procedures used within the biophysical department with a specific focus on Routine Testing and advanced Routine Testing Procedures. This includes understanding of sample type, purpose of test selection, necessary supplies and documentation expectations as well as developing the ability to troubleshoot and problem solve with scientific guidance.
•    Become proficient in performing a minimum of 3 of the below listed BioPhysical department routine testing methods with a high degree of reliability, efficiency and accuracy: 
o    Analytical Ultracentrifugation (AUC)
o    Size Exclusion HPLC-MALLS (SEC-MALLS)
o    Differential Scanning Calorimetry (DSC)
o    Intrinsic Tryptophan Fluorescence (ITF)
o    Fourier Transform Infrared (FTIR)
o    Dynamic Light Scattering (DLS)
o    Protein Binding via SPR-Biacore
o    Circular Dichroism (CD)
•    Maintain excellent laboratory techniques including: 
o    pipetting 
o    weighing material on an analytical balance
o    reagent preparation 
•    Update sample-tracking databases and maintain chemical/consumables inventory for the laboratory.
•    Analyze data and report results of experiments and procedures .
•    Competently perform peer review of data.
•    For both cGMP and R&D grade routine testing, generate biophysical data and technical reports 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 troubleshooting, preventative maintenance, and qualification programs under guidance from senior members of the group.
•    Maintain a safe working environment by adhering to company policies and procedures. Actively participate in laboratory maintenance. 
•    Comply with all pertinent regulatory standards regarding environs, equipment, and testing services.
•    Perform Assay and equipment troubleshooting under guidance from senior members of the group. 
•    Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work.
•    Independently compose high quality written reports such as deviation reports and change control documentation.
•    Review and edit SOPs, protocols, and testing documentation. 
•    Follow all SOPs, CTMs and cGMPs as they relate to specific tasks.
•    Assist in training of junior staff.
•    Perform all other related duties as assigned.

Job Qualifications

•    Education:  Bachelor’s degree (B.S.) or equivalent in biochemistry, chemistry or related discipline.
•    Experience:  1 to 3 years related industry experience in a biophysical science area in the Pharmaceutical, Biotech or contract (CRO) laboratory environment.  
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Other:  Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.  Knowledge of basic protein /peptide biophysical techniques and ability to operate typical laboratory equipment, specifically HPLC, spectrophotometer, dialysis/buffer exchange via SPE, and other laboratory equipment a plus.  Strong organizational and prioritization skills required. Attention to detail and accuracy a must.  Must possess excellent interpersonal skills to maintain communication across functional groups. Ability to collaborate effectively within a group environment. Able to communicate effectively (verbal and written) in a small group or one on one setting. Basic Microsoft Office skills are required. Ability to understand and use internal software programs such as LIMS required. 
 

Compensation Data

The pay range for this position is $26.55 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.