Lab Manager Position Overview
The Lab Manager is responsible for providing support to our Biopharma department by leading and coaching group leaders, scientists, and project managers in laboratory operations.
* Scheduling and resource management
* Technical and compliance-related issues
* Planning, directing, and implementing improvements in systems, processes, and procedures to increase efficiency, productivity, and quality in the laboratory
The role also assists the division director in longer-term planning, business development, and expansion initiatives by providing mid-range (1-3 month) resource utilization predictions for a department.
Key Responsibilities:
1. Interact with clients and business development on requests for proposals and project definition
2. Prepare, review, and approve bids and proposals, scope of work, and pricing
3. Negotiate with clients on timelines and pricing
4. Lead/direct work responsibilities of group leaders and prioritize tasks and resources
5. Review data for technical quality and compliance to protocols, methods, and SOPs
6. Review and approve laboratory investigation, deviations, and QA facility and data audits
7. Lead client and regulatory audits
8. Prepare and update revenue projection reports, review partner and timesheet reports for revenue recognition and billing, evaluate resource utilization reports, and project profitability
9. Review and approve study protocols, project status reports, final study reports, and other project-related technical documentation
Requirements:
* Previous experience that provides knowledge, skills, and abilities to perform the job (comparable to 10+ years)
* 5+ years of management responsibility
* Proven leadership skills
Desirable Skills and Qualifications:
* Full understanding of laboratory requirements, PPD SOPs, ICH guidelines, USP requirements, and FDA guidance
* Proven technical troubleshooting analytical instrumentation and problem-solving abilities
* Excellent written and oral communication skills
* Project and time management skills
* Ability to implement quality systems and process improvements
* Ability to provide guidance to clients on analytical issues and regulatory requirements
* Knowledge of budgeting, forecasting, and fiscal management
* Demonstrated coaching and mentoring skills
* Demonstrated longer-term planning skill
* Strong organizational agility and demonstrated drive for results
Work Environment:
* Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner
* Able to work upright and stationary and/or standing for typical working hours
* Able to lift and move objects up to 25 pounds
* Able to work in non-traditional work environments
* Able to use and learn standard office equipment and technology with proficiency