Associate Scientist, QC Client Services

About the Role

We are LOTTE BIOLOGICS, delivering therapies that enable a healthier world. As the Associate Scientist, QC Client Services, you will provide technical expertise to clients in Quality Control (Microbiological and Analytical) testing, including technical transfer and data integrity evaluation. This role involves authoring technical documents, client interfacing, sample testing, data review, and supporting key business activities in accordance with cGMP regulations and departmental procedures.

Responsibilities

• Author technical documentation to completion.
• Assist Quality in completing new technical method qualifications and modalities.
• Assist Quality in completing data integrity assessments for new instrumentation and modalities.
• Provide client-facing support for existing and potential clients.
• Perform sample testing and data review.
• Apply in-depth knowledge of microbiological and analytical techniques.
• Work independently with demonstrated proficiency.
• Assist with scientific insight for laboratory investigations, root cause analysis for laboratory errors, and identification of corrective/preventive actions.
• Accurately document laboratory work.
• Maintain knowledge of current regulations pertaining to your area of expertise.
• Assist with scientific insight for trends or results.
• Support determination of instrument performance checks/calibrations and participate in new instrument qualifications.
• Provide scientific oversight for troubleshooting instrumentation and methods; recognize issues and recommend resolutions to management.
• Provide scientific review during revision of SOPs as required.
• Seek to improve and obtain new technical skills and share learnings with the department.
• Participate in filing review activities for your area of expertise.
• Maintain and promote a safe working environment.

Requirements

• B.A. or B.S. degree in Biological Sciences or a related field with greater than 3 years of cGMP laboratory experience and/or relevant biopharmaceutical industry experience.
• Demonstrated expert-level theoretical and technical knowledge in your area of concentration, including hands-on training and cGMP experience within the laboratory setting.
• Instrumentation experience in your area of concentration.
• Familiarity with pharmaceutical regulations and general compendia (USP/EP/JP) methodology and instrumentation requirements.
• Self-directed with a high degree of professional integrity, organization, and attention to detail.
• Demonstrated problem-solving ability and effective technical troubleshooting.
• Strong interpersonal, oral, and written communication skills.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines, and maintain flexibility and attention to detail.
• Ability to work independently and in a team-based, collaborative environment.

Physical Demands

• Frequent repeated motions such as pipetting, lifting, bending, twisting, squatting, crouching, kneeling, climbing on stepstools, and reaching.
• Frequent unassisted lifting (not to exceed 50 lbs.).
• Repetitive use of arms, hands, wrists, and grasping.

Work Environment

• Office and laboratory-based role requiring the use of appropriate personal protective equipment (PPE).
• Safe interaction with biohazardous materials, powdered materials, and high-temperature liquids and solids.
• Primarily indoor work, involving both independent and team-based activities.
• May require shift work, weekends, and holidays.

Travel

Less than 5% travel is required for this position.

Pay

Pay range: $28.85 USD - $42.31 USD per hour.

Benefits

Target bonus: 8%.