Job Summary

Under direct supervision, perform Routine analytical methods 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.  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. 
•    Become proficient in performing a minimum of 4 different Routine Tests within the Analytical Department. Routine Tests may include but are not limited to:
o    Appearance 
o    Endotoxin 
o    HIAC
o    Karl Fisher
o    Osmolality
o    PH
o    SoloVPE
•    Develop and Maintain excellent single pipetting skills. 
•    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.
•    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.
•    Make detailed observations and maintain clear, detailed, accurate and timely documentation of all laboratory work.
•    Compose high quality documentation including deviation reports and change control documentation under guidance. 
•    Follow all SOPs, CTMs and cGMP as they relate to specific tasks.
•    Assist in training of Junior staff. 
•    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:  0 to 2 years related industry experience in an analytical 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 analytical techniques and ability to operate typical laboratory equipment, specifically HPLC, Plate Reader, CE, spectrophotometer 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 $23.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.