Associate Director/Large Molecule Group　※CMIC, Inc.

POSITION PURPOSE:

The Associate Director/Large Molecule is responsible for leading the large molecule teams for successful study execution and meeting laboratory overall objectives and timelines.  Actively participates in business discussions, service promotions, and new service creation

Will serve as a Principal Investigator (PI); managing a team of analysts and achieving unit objectives within time constraints by successfully managing and conducting multiple study initiations, executions and completions within designated timelines and budget, and meeting company quality standards.  Effectively communicate with clients; present experimental results to internal and external clients.  Document work and maintain study documentation and lab records. 

RESPONSIBILITIES:

• Ensure GxP (when applicable) and 21 CFR part 11 compliance for Bioanalysis.
• Ensure CMIC internal procedures and policies are properly followed by your team members
• Ability to assume PI role in accordance with GxP requirements and participate in lab activities.
• Proficient communication skills with sponsors, lab staffs, QA and officers.
• Must effectively manage the timelines for his/her groups, and achieve project objectives within time constraints
• Act of a subject matter expect. Troubleshoot, recommend alternative methods of solving a problem and develop solutions to problems.
• Manage, mentor and coach a team of analysts. Build and maintain a cohesive team.
• Lead lab improvement including operation efficiency.
• Effective time management, organization, and teamwork skills as well as attention to detail with the ability to multitask.
• Responsible for confidential and time sensitive material.
• Recommend and develop technology innovation. Assist with new service creation.
• Assumes other activities and responsibilities as assigned.
REQUIREMENTS:

Qualifications

7+ years working in a GLP Bioanalysis laboratory environment performing timely study management from bioanalysis sample processing, validation, and conducting and troubleshooting pre-study work independently with Instrument hands-on experience of ECL - MSD S600, ELISA – absorbance, fluorescence, luminescence; qPCR – Quant Studio 5; and or Cytoflex – Flow Cytometer for large molecule. Management Duties.

M.S. in related field or Equivalent. PhD preferred.

Experience and Skills

Proficient in method development, method validation, bio-sample preparation and study sample analysis.
・ELISA – absorbance, fluorescence, luminescence
・ECL - MSD S600
・qPCR – Quant Studio 5
・Cytoflex – Flow Cytometer
・Proficient troubleshooting skills.
・Maintain quality execution and work.
・Demonstrated effective oral and written communication skills.
・Staff, team management with the ability to mentor, coach and build analysts skillsets
・Effective time management skills; complete unit goals in a timely manner and within allotted budget. (i.e. maintain timelines).
・Manage lab equipment usage and maintain lab equipment appropriately for assigned tasks.
・Understand and mentor GxP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
・Ability to proactively prevent non-compliant issues in lab operations.
・Ability to handle confidential information.
・Proficient presentation skills.
・Proficient in MS Office and to be adept at learning new systems