Job Title: Senior Level or Group Leader (Large Molecule)
Position Summary: We are seeking a Group leader for Large Molecule Bioanalysis responsible for large molecule strategy, technology, and lab productivity. Lead a team of laboratory scientists to achieve client commitments, meet quality standards, and department goals. Key contact for scientific interactions with customers. Plan and direct proficient method development and validation for immunoassays. Prepare Standard Operation procedures, work sheets, study plans, and final reports. Serve as a Leader/technical contributor to presentations, scientific papers, and industry conferences. Coach and mentor technical talent. Ability to handle multiple projects at a time.
Major Responsibilities Include:
- Ensure GLP, GCP (when applicable) and part 11compliance for large molecule lab activities. Ensure internal procedures and policies are properly followed by large molecule lab staffs.
- Ability to manage a group of analysts and PI. Provide necessary training for staffs. Ensure large molecule team is compliance with CAPA program. Mentoring for PIs and lab staffs and ability to resolve concerns from labs. Must effectively manage the timelines for his/her groups, and achieve project objectives within time constraints. Strong QC and review abilities for study plans, analytical data and reports.
- Ability to assume PI role in accordance with GLP requirements and participate in lab activities. 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 the 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.
- Knowledge of alternative methods of solving a problem, and well-developed ability to find solutions to problems using the scientific literature.
- Knowledge of alternative methods of solving a problem, and well-developed ability to find solutions to problems using the scientific literature
- BA in biochemistry, analytical chemistry, biotechnology, pharmaceutical sciences, or related field. Ph.D preferred
- ELISA experience and sample Prep of biological matrices
- Understand GLP requirements, SOP/SWPs and related lab procedures; safety policies and company policies.
- Use and maintain lab equipment appropriately for assigned tasks.
- Conduct Bio-analysis validation and sample analysis with minimal supervision meeting company quality standards
- Maintain quality execution and work.
- Ability to understand basic troubleshooting skills.
- QC the Plans, Methods and Reports.