Associate Director (Small Molecule) ※IL, US office
The Associate Director is an inspiration to the group, motivating and leading laboratory activities and functions. In this role, you are responsible leading teams for successful study execution and meeting laboratory overall objectives and timelines. Actively participating in business discussions, service promotions, and new service creation and implementation.
Ensure study executions in compliance with GxP and 21 CFR Part 11; proactively identify laboratory issues and make recommendations. Ensure your respective lab operations for each team are performed effectively and provide directions for remedy actions. Maintain effective daily lab operations including providing direction, mentoring and coaching to lesser-skilled teams of analysts to build skillsets.
You will also 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. You are expected to recommend alternative methods for solving a problem. Effectively communicate with clients; present experimental results to internal and external clients. Document work and maintain study documentation and lab records.
You will participate in the quotation process, SOP and other technical related document preparation.
- 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.
- Provide necessary training for staffs.
- Ability to assume PI role in accordance with GxP requirements and participate in lab activities. Ability to manage a group of analysts and PIs. Work with Business Development to insure project management is aligned with sponsors and regulatory requirements.
- Ability to present experimental results during group meetings and to CMIC management team. Proficient communication skills with sponsors, lab staffs, QA and officers. Provide written summaries of work for presentation to clients and regular updates to senior management team.
- 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. Perform evaluations and set goals; ensure unit goals are being met. Address performance related concerns as need arise.
- Lead lab improvement including operation efficiency.
- Participate in the quotation process; audit process; audit visits; client visits.
- May participate in interview process.
- 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.
- Participate in marketing efforts through publications, presentations, posters.
- Recommend and develop technology innovation. Assist with new service creation.
- Assumes other activities and responsibilities as assigned.
- Minimum 7+ years experience within a BioA laboratory with solid publication track record; and at least 2 years leadership and experience.
- PhD in related field (i.e. chemistry, biochemistry, biotechnology, pharmacognosy) or Equivalent
Experience and Skills
- Proficient in method development, method validation, bio-sample preparation and study sample analysis.
- LC-MS/MS instrument
- 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.
- Ability to independently create publications, presentations and posters.
- Proficient in MS Office and to be adept at learning new systems.
Interested parties please send your application via email to Denise Washick (Denise-Washick@cmicgroup.com).