Job Summary

Perform routine analytical methods 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 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 analytical 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 trouble shoot and problem solve with scientific guidance. 
•    Demonstrate 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
•    Become proficient in performing at least 2 Advanced Routine Testing offerings which include but are not limited to:
o    SDS Page
o    Native Page
o    HPLC Methods
o    Elisa Methods
o    N-Terminal Sequencing
•    Develop and Maintain excellent pipetting skills as listed below:
o    Single Pipetting 
o    Multichannel pipetting
•    Analyze data and report results of experiments and procedures.
•    Competently perform peer review of data
•    For cGMP and R&D 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 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 documentation including 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. 
•    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 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 an analytical science area in the Pharmaceutical, Biotech or contract 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:  Knowledge of cGMPs or regulatory affairs pertaining to the pharmaceutical and biological industries is preferred.  Knowledge of basic protein /peptide analytical techniques and ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer and other laboratory equipment required.  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.  Basic Microsoft Office skills are required.  Ability to understand and use internal software programs such as LIMS required.
•    Able to communicate effectively in a small group or one on one setting.  Basic Microsoft Office skills are 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.