Assistant Scientist, Microbiological Control

Lotte Biologics USA LLC

We are LOTTE BIOLOGICS ! Delivering Therapies That Enable a Healthier World.

A new company, built on 80 years of tradition. We embody our core values of being Inspired by Science, Embracing Diversity, Fostering Talent, and Connecting Lives. Our mission is to be the most trusted partner in the industry, with high standards of quality and continuous innovation, to reliably deliver benefits for patients worldwide.

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%

New York Pay Range

$58,500 — $72,000 USD

Work Location

East Syracuse, NY

We are an Equal Employment Opportunity (“EEO”) Employer.

We believe that women, people of color, veterans and LGBTQ communities must participate in the work we do, so we strongly encourage applications from people with these identities or who are members of underrepresented communities!  If this is the work that you want to do, in a culture of inclusion and excellence with the goal of making our world to be a healthier place, then please apply today!

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