Job Summary

Perform advanced routine analytical methods, data interpretation and reporting independently as specified in standard in-house SOPs, Client Test Methods and other written procedures. 

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 cGMP and R&D grade reports
•    Demonstrated proficiency in performing the Basic Routine testing offerings as identified below: 
o    Appearance 
o    Endotoxin 
o    HIAC
o    Karl Fisher
o    Osmolality
o    PH
o    SoloVPE
•    Demonstrated proficiency in Advanced Routine Testing offerings which include but are not limited to:
o    SDS Page
o    Native Page
o    HPLC Methods
o    N-Terminal Sequencing
o    Elisa Methods
•    Develop and Maintain excellent pipetting skills as listed below:
o    Single Pipetting
o    Multichannel pipetting
o    Repeat Pipetting 
o    Reverse Pipetting
•    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 and all ensure data packages are complete and compliant.
•    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 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 documentation including deviation reports and change control documentation with no/minimal guidance. 
•    Participate in client/sponsor relationships (e.g. technology transfer, conference calls and sharing of technical information).
•    Follow all SOPs, CTMs and cGMP 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 an analytical laboratory in the Pharmaceutical, Biotech or contract research laboratory (CRO) environment.  
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
•    Other: Demonstrated knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred. Able to apply knowledge of analytical chemistry to complex assays. Knowledge of basic protein /peptide analytical techniques and demonstrated ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.  Demonstrated independent analytical and problem-solving abilities. 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 (verbal and written) effectively in a small group or one on one setting.  Computer proficiency in MS Word, Excel, Outlook, instrumentation and analysis software. 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.