Scientist l, Analytical Operations
Core
Manage laboratory instrumentation projects, data integrity, and ancillary lab systems to support pharmaceutical pipeline activities.
Role type
Senior IC analytical operations scientist
Builds
Laboratory instrumentation support, data integrity systems, and ancillary lab utilities
Domain
Pharmaceutical manufacturing / Analytical operations
Deliverable
infrastructure
Required skills
Analytical development, cGMP compliance, international pharmaceutical regulations, instrument qualification, data integrity management, SOP authoring, project coordination, audit preparation, process improvement
Preferred skills
Leadership of temporary workers, cross-departmental strategy, regulatory guidance for novel instrumentation
Technologies
Laboratory instrumentation, computerized instrument support systems, chamber profiling systems, alarm monitoring systems, water systems, monitoring systems, utilities systems
Responsibilities
Manage projects related to laboratory instrumentation installation, calibration, qualification, decommission, and moves; Author, review, and contribute to quality documentation including SOPs and software configuration documents; Collaborate with internal and external partners to maintain alignment on project scope and timelines; Manage and multitask instrument activities to support the pipeline; Participate in preparation for and support of audits on instrumentation and data integrity topics; Maintain activities supported by ARD LC IMT including OOT and instrument inventory; Support other cGMP quality activities within function