Job Summary

Perform multiple routine biophysical methods, data interpretation, and reporting 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 maintenance / monitoring of equipment, routine testing of client samples, and the generation of routine GMP and R&D grade reports.
•    Become proficient in performing a minimum of 4 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 Technical Review for Routine data generated by staff. This includes Review of reports, raw data, or any other data produced by the group to ensure data packages are complete and compliant.
•    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 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 assay and equipment troubleshooting with minimal guidance from senior members of the group. 
•    Make detailed observations and maintain clear, accurate and timely documentation of all laboratory work. 
•    Independently compose high quality written reports such as deviation reports and change control documentation.
•    Create, 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.
•    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.

Job Qualifications

•    Education: Bachelor’s degree (B.S.) or equivalent in biochemistry, chemistry or related discipline. 
•    Experience: Minimum 3-5 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
•    Certification/Licensure: None.
•    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 $31.25 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.