Scientist l, Analytical Operations
AbbVie
8 hours ago
On-site
North Chicago, IL
$75,000 - $142,500 USD yearly
Operations
Responsibilities:
- Manage projects for laboratory instrumentation (installation, calibration, qualification, decommission, instrument moves), data integrity (DI), computerized aspects of instrument support, controlled storage (e.g., chamber profiling, alarm monitoring), and ancillary lab systems (e.g., water, monitoring systems, utilities).
- Author, review, and/or contribute to quality documentation (experimental protocols, results summaries, SOPs, software configuration documents as needed).
- Coordinate with internal/external partners (lab personnel, QA, concierge services, Validation Review Board, IT/BTS, contractors, vendors) to align scope, timelines, and deliverables.
- Manage and multitask instrument activities to support pipeline; escalate concerns and deliver critical lab priorities on time.
- Maintain knowledge of instrument processes and implement process improvements.
- Support audits on instrumentation and data integrity, including follow-on activities.
- Maintain ARD LC IMT activities (e.g., OOT, instrument inventory, instrument scheduler, red stickers).
- Support other cGMP quality activities as needed.
- May lead, develop, and coach temporary workers and summer interns; drive/coordinate operational decisions on a site basis.
- Provide guidance on regulatory/cGMP expectations for novel analytical instrumentation.
Qualifications:
- Bachelor’s degree (or equivalent) with 5 years’ experience; or Master’s degree (or equivalent) with typically 2 years’ experience.
- Demonstrated theoretical and practical knowledge/experience in analytical development, including international pharmaceutical regulations and cGMPs.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.
- Manage projects for laboratory instrumentation (installation, calibration, qualification, decommission, instrument moves), data integrity (DI), computerized aspects of instrument support, controlled storage (e.g., chamber profiling, alarm monitoring), and ancillary lab systems (e.g., water, monitoring systems, utilities).
- Author, review, and/or contribute to quality documentation (experimental protocols, results summaries, SOPs, software configuration documents as needed).
- Coordinate with internal/external partners (lab personnel, QA, concierge services, Validation Review Board, IT/BTS, contractors, vendors) to align scope, timelines, and deliverables.
- Manage and multitask instrument activities to support pipeline; escalate concerns and deliver critical lab priorities on time.
- Maintain knowledge of instrument processes and implement process improvements.
- Support audits on instrumentation and data integrity, including follow-on activities.
- Maintain ARD LC IMT activities (e.g., OOT, instrument inventory, instrument scheduler, red stickers).
- Support other cGMP quality activities as needed.
- May lead, develop, and coach temporary workers and summer interns; drive/coordinate operational decisions on a site basis.
- Provide guidance on regulatory/cGMP expectations for novel analytical instrumentation.
Qualifications:
- Bachelor’s degree (or equivalent) with 5 years’ experience; or Master’s degree (or equivalent) with typically 2 years’ experience.
- Demonstrated theoretical and practical knowledge/experience in analytical development, including international pharmaceutical regulations and cGMPs.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligible for short-term incentive programs.