Scientist l, Analytical Operations

About the Role

Manage projects related to laboratory instrumentation (e.g. Installation, Calibration, Qualification, Decommission, Instrument Moves), Data Integrity (DI) and computerized aspects of instrument support, Controlled Storage (e.g. Chamber Profiling, Alarm Monitoring), and ancillary lab systems (e.g. water, monitoring systems, utilities, etc.).

Responsibilities

• Author, review, and/or contribute to quality related documentation, including experimental protocols, results summaries, Standard Operating Procedures (SOPs), and software configuration documents as needed.
• Collaborate and/or coordinate with internal and external partners (e.g. Laboratory Personnel, Quality Assurance (QA), Concierge Services (CS), Validation Review Board (VRB), BTS (IT), third-party contractors, external vendors) to maintain alignment on project scope, timelines, and deliverables.
• Manage and multitask instrument activities to support the pipeline and escalate concerns appropriately. Ensure that critical lab priorities are delivered in a timely manner to support pipeline activities.
• Maintain a deep knowledge of instrument processes and support process improvement updates where needed.
• Participate in preparation for and support of audits on instrumentation and data integrity topics, including follow-on activities.
• Maintain activities supported by ARD LC IMT (e.g. Out of Tolerance (OOT), instrument inventory, instrument scheduler, red stickers).
• Support other cGMP quality activities within function as needed.
• May have opportunity to lead, develop, and coach temporary workers and summer interns.
• Drives/coordinates operational decision making on a site basis.
• Adapts to changing environments and balances priorities.
• Supports project development of technological innovations by providing guidance on regulatory / cGMP expectations for novel analytical instrumentation.
• Builds strong relationships with peers to create and implement cross-departmental operational strategies.
• Knows the business to influence long-range strategies.
• Creates a learning environment, open to suggestions and experimentation.
• Deals comfortably with uncertainty, ambiguity, and risk ensuring alignment with corporate/regulatory policies/standards.
• Raises the bar and drives the function to efficient/reliable execution.
• Learns fast, grasps the essence and can change course quickly where indicated.

Qualifications

• Bachelors Degree or equivalent education with 5 years of experience, OR Masters Degree or equivalent education with typically 2 years of experience.
• Must have demonstrated theoretical and practical knowledge and experience in analytical development including international pharmaceutical regulations and cGMPs.