BASIC SUMMARY:
Under direct supervision, the Laboratory Technician I will perform routine analytical methods as specified in written procedures (e.g., in-house SOPs, client test methods) for quality control, release/stability testing.
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.
• Adhere to established processes for laboratory operations and execution of routine testing.
• Perform routine tests of release and/or stability samples.
• Demonstrate proficiency in performing different routine tests within the RightSource laboratory.
• Analyze data and report results of experiments and procedures.
• Competently perform peer review of data.
• Generate analytical data and technical report(s) on-time with respect to internal and client deadlines.
• Maintain a safe working environment by adhering to company policies and procedures.
• Actively participate in laboratory operations and maintenance including but not limited to:
o Laboratory cleaning and organization
o Instrumentation and equipment maintenance
o Preparation of common stocks
o Ordering and inventory of materials
• Comply with all pertinent regulatory standards regarding environments, 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, TRs and cGMP as they relate to specific tasks.
• 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.
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 (CDMO/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 standard laboratory equipment. 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. Authorized to legally work in the United States without visa sponsorship.
PHYSICAL DEMANDS:
• Must regularly operate a computer and occasionally operate other office productivity machinery such as a calculator, copy machine, and computer printer.
• Must regularly communicate with employees/customer; must be able to exchange accurate information.
• Must be able to remain in a stationary position for extended periods of time while performing laboratory tasks.
• Must be able to observe, inspect, and interpret laboratory experiments, requiring color vision, close vision and the ability to adjust focus and detect and differentiate colors.
• Must be able to frequently and accurately operate laboratory pipettes.
• Must be able to work in laboratory settings and adhere to all safety precautions.
• Must be able, when required, to work weekends, nights, or be on-call to support the manufacturing campaigns.
• Physically able to lift and/or move up to 10 pounds and may occasionally lift and/or move up to 50 pounds.
WORK ENVIRONMENT:
• General laboratory working conditions.
• Regularly wears protective clothing (gloves, lab coat, safety glasses).
• Regularly works with or near toxic or caustic chemicals.
• May be exposed to fumes or airborne particles.
• Regularly works at a chemical fume hood.
• May work with biohazards.
• Occasionally may be exposed to unpleasant odors.
• The employee may work with sharp objects (i.e. needles, glass pipettes, pipet tips).
• The noise level in the work environment is usually moderate.
COMMENTS:
• This position may require overtime, weekend, holiday, and/or after hours shift coverage, as needed.
