QC Laboratory SME

Our client is looking to add a QC Laboratory SME that will be responsible for the management of product specification lifecycle, reference standard and critical reagent programs, analytical method lifecycle, and performance monitoring, at the state-of-the-art facility located in Lexington, MA.  This person will collaborate with multiple stakeholders, including Analytical Development, Regulatory, and Quality Assurance.

• Management of the global Reference Standard lifecycle program, including the procurement, qualification, storage, and requalification.
• Maintenance of the global QC critical reagent program.
• Management of the Specification Review Board.
• Management of the global Product Specification program, including early clinical to commercialization lifecycle.
• Management of assay trending program. 
• May partner with Analytical Development for investigation support and continuous improvement activities related to analytical methods.
• May partner with Analytical Development group to ensure methods are effectively transferred into Quality Control and analytical instrumentation is aligned.
• Write protocols and reports that are needed.
• Develop, revise and review SOPs.
• Gather metric information for use in continuous improvement.
• Represent QC at inter-departmental meetings and interact with both internal customers as well as external vendors, as needed.
• Manage protocol excursions and related root cause investigations.
• May manage Deviations, CAPA, and Change Control within the department.
• May assist with the preparation of the CMC section of dossiers and the creation of data packages for Regulatory agencies.
• Support inspection readiness activities.

Educational and Other Requirements:

• Minimum BA or BS in STEM.
• 5-10+ years of laboratory experience in a QC testing capacity within a cGMP setting.
• Large molecule, gene, or cell therapy experience is required.
• Excellent time management skills; organized and able to meet company deadlines.
• Ability to work and prioritize under pressure in an international environment.
• Familiar with FDA and EMA guidance documents relevant to gene therapy.
• Working knowledge of quality systems requirements.
• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities
• Computer literacy (MS Word, Excel, and LIMS).
• Good/effective communication and organizational skills with the ability to work well with others and independently.
• Ability to work collaboratively with cross-functional departments.