Lab Manager
PPD, Inc.
King of Prussia, PA, 19406, USA
At PPD, you'll have the freedom to try new ideas and the ability to do something truly great. In our environment, innovation is encouraged. That's why the world's leading pharmaceutical and biotechnology companies come to us for discovery and development services. And why PPD is the best choice for you and for your career. DescriptionThe basic purpose of this position is to ensure efficient and effective management of PPD resources. The objective is to supervise and assist group leaders and scientists in laboratory operations with tasks such as scheduling, resource management, technical and compliance related issues. To plan, direct and implement improvements in systems, processes and procedures to increase efficiency, productivity and quality in the laboratory. This position assists the division director in strategic planning, business development and expansion initiatives by providing mid range (1-3 month) resource utilization predictions for a department.Qualifications Education and Experience:
B.S. in Biochemistry or related science plus 10 or more years experience in a pharmaceutical or biotech laboratory OR M.S. in Biochemistry or related science plus 8 or more years experience in a pharmaceutical or biotech laboratory OR Ph.D. in Biochemistry or related science plus at least 6 years experience in a pharmaceutical or biotech laboratory 5 years management experience in the pharmaceutical, biotech or analytical contract laboratory industries. Management experience should include stability/QC/analytical R&D/ 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 Knowledge, Skills and Abilities:
Full understanding of cGMP requirements, PPD & client SOPs and quality systems, ICH guidelines, USP requirements and FDA guidance Full understanding and knowledge of separation science and general chemistry and biochemistry Proven technical troubleshooting and problem solving abilities Effective technical writing skills Ability to manage multiple project teams 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 as it applie
B.S. in Biochemistry or related science plus 10 or more years experience in a pharmaceutical or biotech laboratory OR M.S. in Biochemistry or related science plus 8 or more years experience in a pharmaceutical or biotech laboratory OR Ph.D. in Biochemistry or related science plus at least 6 years experience in a pharmaceutical or biotech laboratory 5 years management experience in the pharmaceutical, biotech or analytical contract laboratory industries. Management experience should include stability/QC/analytical R&D/ 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 Knowledge, Skills and Abilities:
Full understanding of cGMP requirements, PPD & client SOPs and quality systems, ICH guidelines, USP requirements and FDA guidance Full understanding and knowledge of separation science and general chemistry and biochemistry Proven technical troubleshooting and problem solving abilities Effective technical writing skills Ability to manage multiple project teams 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 as it applie
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