Assistant Scientist, Microbiological Control - LOTTE BIOLOGICS USA, LLC

Position Summary

The Microbiological Control (MC) Laboratory supports the onsite commercial and contract development manufacturing facilities and laboratories. The Assistant Scientist conducts routine microbiological laboratory testing of raw materials, in-process and release drug substance samples in compliance with methods, procedures, protocols, and regulatory requirements. The Assistant Scientist performs identification of microorganisms according to defined procedures and lab analysis of environmental and utility samples.

Duties & Responsibilities

• Perform laboratory analysis of samples, using aseptic technique, following established procedures and in full compliance with official compendia, health authority regulations, and established site policies.
• Maintains accurate records of work performed and documents results, according to good documentation practices and established procedures as well as perform data entry into electronic systems.
• Operates and maintains laboratory instruments, while ensuring the reliability of instrumentation through proper maintenance, with ability to troubleshoot minor issues.
• Analyze, evaluate, and interpret data, notifying clients of results, and assist in resolving issues, if applicable.
• Promotes quality, safety, and health by ensuring clean work area, and adherence to procedures and safety culture.
• Participate in continuous improvement efforts using lean principles to assist with streamlining and making the laboratory efficient.

Education & Experience

• B.S. degree in Biological Sciences or related field with 0-3 years of QC microbiology laboratory experience.

Knowledge, Skills, Abilities

• Knowledge of Quality Control Microbiological testing. Environmental monitoring knowledge is desirable.
• Excellent manual dexterity and aseptic technique.
• Complete sampling or testing assignments in a timely and compliant manner, with minimal supervision.
• Perform limited interpretation of data.
• Knowledge of cGMPs and compendia testing.
• Proficient verbal and written communication skills.

Work Environment

• This position is based indoors in a laboratory and primarily working with others, but also independently and alone at times. This position is a team-based position that will require shift work, weekends, and holidays.
• Shift schedule is Wednesday - Saturday, 10-hour shifts. 

Physical Demands

• This position is a lab-based position which requires appropriate levels of personal protective equipment (PPE). This role will require contact with biohazardous materials such as live cell cultures and other hazardous chemicals including methotrexate, acids, and caustics. Powdered materials and high temperature liquids and solids are also handled.
• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, and reaching is required.
• This role also requires frequent unassisted lifting (not to exceed 50 lbs).
• Repetitive use of arms/hands/wrists and grasping is also required.
• Depending on the work demands, office-based work requires sitting.

Shift Differential

5%

Target Bonus:

8%