The role of the successful Laboratory Manager is to provide leadership and support to Group Leaders, Scientists, and Project Managers in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. You will plan, direct and implement improvements in systems, processes, and procedures to increase efficiency, productivity and quality in the laboratory.
You will also assist the Biopharm Associate Director in strategic planning, business development, and expansion initiatives.
The Laboratory Manager will foster a positive and encouraging environment and motivate the team for success. In total, the Laboratory Manager will have the accountability of a team of around 30, with this group continually growing.
Laboratory Manager responsibilities
- Manages/directs work responsibilities of group leaders as well as prioritize projects and resources
- Providing leadership and support to multiple employees in a positive and encouraging manner to motivate the team with drive, energy, and enthusiasm
- Reviews data for technical quality and compliance to protocols, methods and SOPs. Reviews and approves laboratory investigation, deviations, and QA facility and data audits. Leads client and regulatory audits
- Reviews and approves study protocols, project status reports, final study reports and other project related technical documentation
- Interacts with clients and business development on requests for proposals and project definition. Prepares, reviews and approves bids and proposals, scope of work and pricing. Negotiates with clients on timelines and pricing
- Prepares and updates revenue projection reports and timesheet reports for revenue recognition and billing, evaluates resource utilization reports and project profitability
- Assists upper management in strategic planning, budgeting, new capabilities development, makes recommendations on process improvement and fosters a GMP culture
Laboratory Manager skills and experience
- Educated to a Bachelor’s Degree level in a relevant area, ie chemistry, biochemistry
- 10+ years’ experience in the Pharmaceutical, Biotech, or Analytical Contract Laboratory industries within Stability, QC or analytical development departments
- 5+ years’ experience managing a team of technical staff with proven leadership record and evidence of team development
- Demonstrated strategic planning skills
- Knowledge of budgeting, forecasting, and fiscal management
- Full understanding of cGMP requirements, client SOPs, ICH guidelines, EP and USP requirements, and EMEA and FDA guidance.
- Strong ability to perform root cause analysis and implement effective CAPA
- Knowledge and experience of a wide range of techniques, HPLC, UPLC, Electrophoresis (CE, iCE, SDS-PAGE), ELISA, spectrophotometry with proven technical troubleshooting and problem-solving abilities
This role offers an excellent opportunity for someone who has previous leadership and management experience in GMP small molecule environment; who would now like to embrace a new technical environment/Biopharm specific products.