Laboratory Manager,Testing and Analytics

King of Prussia

Summary

This role of the Laboratory Team Lead (Lab Manager) is to facilitate the setup and operation of a routine testing Laboratory. Working with stakeholders within Quality, Laboratory Operations, Project Management and Finance together with leadership, establish a laboratory operation capable of delivering specified testing services to the Global market. The role would suit a candidate who has experience within a CRO/CDMO environment and/or has a desire to make an impact to a growing business. The role will require delivery of scientific services to the within the Cell and gene therapy market space

Responsibilities

·Manage space allocation, equipment, lab supplies and general organization of the lab spaces and regularly audit various labs for safety, cleanliness, and organization

·Help establish and ensure adherence to standard operating procedures, housekeeping practices, and material needs in the lab spaces

·Manage a team of laboratory staff executing R&D and cGMP testing

·Design and implement studies that meet Client’s needs in a scientifically sound and cost-effective manner.

·Understand scientifically complex projects, and ensure the projects are on time, on budget, and meet pre-established quality standards

·Maintain accurate scientific/technical records in internal databases and a thorough knowledge of various regulatory and Laboratory control processes.

·Efficiently and effectively interact with different teams daily including scientists, Laboratory management and Client representatives.

·Build up knowledge on CGT products/assay/tools, techniques, and regulatory guidelines

·Ensure and improve safety procedures within the lab environment

·Drive continuous improvement through lean techniques.

·Increase test process efficiencies including optimizing equipment utilization

·Reduce lead times through reduction of testing downtime and improved process flow

·Manage testing workload

·Review and process test protocols from Analytical Development Scientists. Prioritize and assign test protocols to test technicians

·Liaise between test team and Analytical Development team on test status and priorities

·Co-ordinate and provide input for master schedule plan for GMP testing.

·Ensures Testing & Analytical Development staff meet completion dates and compliance with SOPs and cGMP compliance and all other relevant requirements

Qualifications

·Excellent written and verbal communication skills and ability to influence others

·Excellent critical thinking and problem-solving skills

·Detailed and results orientated

·Able to professionally handle multiple and sometimes competing priorities

·Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment

·Ability to lead multi-disciplinary project teams

·Proficiency in Microsoft Office programs including Word, Excel, and MS Project

·Proficiency with ERP, CRM, and Documentation Systems

·Ensures accuracy and relevance of assigned training curriculum

·Drives timely completion of training for employees to meet regulatory requirements

Performance Management, coaching, mentorship, and development of employees

Education & Experience

  • Degree (M.S. or Ph.D.) in molecular biology, Cell Biology, or biochemistry
  • 4-5 years relevant industry experience including knowledge in CMC for early and late-stage development drugs.
  • Scientific background plus working knowledge of general molecular biology techniques, cell culture, PCR, and bioanalysis is also required.
  • Strong work ethic, self-motivation, and ability to adapt in a dynamic team environment are keys for success
  • Experience managing and leading a team
  • Working knowledge of CGT product development is preferred
  • Lab experience with HPLC and/or, LC/MS/MS is desired
  • Demonstrated ability to work in a fast-paced environment while possessing strong organizational skills and a demonstrated ability to meet deadlines. Strong written and verbal communication skills.
  • Thorough knowledge of Project Management processes, laboratory processes, and equivalent working knowledge of laboratory operations (kits/supplies, logistics, laboratory operations, data reporting and transfers, etc.) required.

Demonstrated computer proficiency with Microsoft Office and the company systems, or equivalent experience with similar Laboratory systems preferred.

Menu