As the Lab Manager - Cell Based Bioassay Lab (GMP), your basic purpose will be to ensure efficient and effective management of PPD resources. You will supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. In addition, you will plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. You will assist the division director in strategic planning, business development and expansion initiatives by providing mid range (1-3 month) resource utilization predictions for a department.
Education and Experience:
- B.S. in Biology, Chemistry or related science plus 10 or more years experience in a pharmaceutical or biotech laboratory
- M.S. in Cell Biology, Chemistry or related science plus 8 or more years experience in a pharmaceutical or biotech laboratory
- Ph.D. in Cell Biology, Biochemistry or related science.
- 6+ years of prior supervisory experience.
- Minimum 5 years management experience, preferably in the pharmaceutical, biotech or analytical contract laboratory industries.
- Management experience should include analytical laboratory project and program management, direct supervision of technical staff, and direction of laboratory operations and implementation of process and system improvements or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
- Extensive cell based biology technical and related, analytical instrumentation (Flow Cytometry/ FACS, ELISA, etc.) expertise.
Knowledge, Skills and Abilities:
- Full understanding of cGMP requirements, PPD and client SOPs, ICH guidelines, USP requirements and FDA guidance
- Full understanding and knowledge of separation science and general chemistry
- Proven technical troubleshooting and problem solving abilities
- Effective technical writing skills
- Ability to manage multiple projects in the pharmaceutical industry or contract laboratory environment
- Ability to implement quality systems and process improvements
- Ability to provide guidance to clients on analytical issues and regulatory requirements
- Understanding of budgeting, revenue projections and other financial terms and definitions at it applies to the business
- Supervisory skills in resource allocation, hiring and recruiting and other related functions
- Leadership skills especially interpersonal and communication skills
- Proven ability to cope with a dynamic work environment.