Scientist - TEMP (Biotech)

Performs professional, technical laboratory functions with versatile capabilities throughout the laboratory.  Serves as a technical resource in the laboratory providing scientific expertise and problem solving skills.

Responsibilities

• Adheres to safety rules and awareness, demonstrates good safety practices at all times. Takes initiative to report and correct safety hazards. Uses Personal Protective Equipment (PPE) associated with assigned tasks.
• Executes against project plans and goals as assigned by Quality Management. Meets productivity, quality and teamwork metrics for level.​
• Performs all assigned tasks according to applicable cGMPs and internal written procedures.
• Follows strict good documentation practices per company's SOP and cGMP regulation.​
• Actively completes assigned training activities and documents training within assigned time frames and before performing any activity associated with the training topic.
• Notifies supervisor immediately regarding testing abnormalities, OOS/OOT results, and deviations from established testing procedures. Serves as a lead investigator in conducting and documenting the investigation.
• Functions as a subject matter expert within the analytical laboratory and provides support at all times.
• Performs training and provides technical support to analysts as required.
• Works under minimal supervision and is expected to independently carry-out non-routine assignments
• Maintains proper documentation of laboratory data (which requires adequate proficiency in written and computational skills).
• Conducts Analytical testing of Raw Materials, Intermediate Products and Finished products as per written procedures and protocols to support material/product release, stability studies, method transfers, and investigations.
• Troubleshoot, operate, and train for testing associated with general analytical instruments for testing of raw material, in process and finished products using instruments such as HPLC, GC, Dissolution, UV, IR, automatic titrator, and viscometer.
• Reviews analytical testing records/logbooks for compliance with cGMPs, compendial requirements, and Noven procedures/protocols.
• Reviews and/or writes technical reports, procedures, and protocols.
• Draws conclusions from data and communicates those conclusions is writing.
• May Schedule laboratory testing and associated activities to minimize operational disruptions to departments.
• May manage inter-departmental projects to ensure timely completion of objectives.
• Completes any other duties assigned by QC management as required.

Qualifications

Competencies:

Education / Experience:

Minimum of four years of experience with a Bachelor degree in chemistry or related scientific field required.  Alternately, three to six years of experience with a Master degree in chemistry or related scientific field. Alternately, zero to three years of experience with a PhD in chemistry or related scientific field. Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories.  Where appropriate the candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques.  Good written English and verbal communication skills.  Must be highly organized and able to work under pressure.  Must have strong interpersonal and leadership skills.  Must be computer literate with knowledge in all Microsoft business applications.  A strong background in scientific software such as Waters Corp. Empower and LIMS is a plus.

 

Judgment / Decision Making:

Duties are performed under general direction toward broad assignments with periodic reviews.  Duties are performed within framework of departmental or functional protocol requiring a high degree of original thinking.

 

Work Environment:

A laboratory environment with exposure to chemicals, caustics, fumes, heat, and odors. Carelessness could result in minor injury.

 

Physical Demands:         

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents.  Majority of time spent sitting and walking.  Occasionally required to lift objects weighing up to 50 pounds.