Job DescriptionThe Operations Manager, Materials Assessment Laboratory (MAL), is responsible for overseeing daily laboratory operations, workflow management, data integrity, training of MAL staff, and continuous improvement initiatives that support efficient and compliant laboratory execution. This role serves to ensure testing activities, laboratory resources, personnel capabilities, digital systems, and facility projects are aligned with Drug Product Design business priorities and project timelines. The Operations Manager collaborates with scientists, formulators, engineering teams, information technology groups, and external vendors to maintain operational excellence and support laboratory initiatives.
Key ResponsibilitiesLaboratory Operations & Workflow Management
- Direct and coordinate daily laboratory operations to ensure efficient execution of testing requests and project deliverables.
- Manage sample submission workflows, testing prioritization, resource allocation, and scheduling to meet business needs and project timelines.
- Monitor laboratory capacity and identify opportunities to eliminate bottlenecks and improve operational efficiency.
- Partner with scientific staff and project teams to align testing activities with organizational priorities.
- Develop and implement operational metrics to track laboratory performance, productivity, and service levels.
Documentation, Reporting & Compliance
- Ensure timely completion and maintenance of laboratory documentation, reports, procedures, and technical records.
- Support preparation and review of scientific reports and project deliverables.
- Maintain compliance with internal quality systems, regulatory expectations, and company policies.
- Drive standardization and continuous improvement of laboratory procedures and operational documentation.
Data Management & Quality Oversight
- Oversee laboratory data management processes, including review of electronic laboratory notebook (eLN) documentation, Compose & Capture records, and associated testing data.
- Ensure data integrity, compliance, traceability, and adherence to laboratory quality standards.
- Support implementation and optimization of digital laboratory systems, including Compose & Capture, MAX, Snowflake, and related platforms.
- Drive continuous improvement efforts related to data workflows, reporting, and digital transformation initiatives.
Training & Cross-Training Staff
- Lead laboratory training and cross-training programs to ensure workforce flexibility, competency, and business continuity.
- Coordinate onboarding and technical training for new laboratory personnel.
- Promote knowledge sharing and standardized work practices across laboratory functions.
Laboratory Infrastructure & Operational Projects
- Manage laboratory renovation, relocation, and facility improvement projects.
- Coordinate equipment moves, facility readiness activities, vendor installations, and commissioning efforts.
- Partner with facilities, engineering, and asset management teams to ensure successful implementation of laboratory infrastructure projects.
- Support space planning and laboratory modernization initiatives.
Equipment Reliability & Vendor Management
- Oversee laboratory equipment lifecycle management, preventive maintenance, calibration schedules, service contracts, and vendor relationships.
- Ensure laboratory instrumentation remains qualified, operational, and compliant with applicable requirements.
- Collaborate with vendors and internal stakeholders to support upgrades, repairs, and technology improvements.
Continuous Improvement & Initiatives
- Lead or support digital transformation, process optimization, and laboratory modernization initiatives.
- Coordinate implementation of new workflows, technologies, and laboratory systems.
- Participate in cross-functional committees, communities of practice, and initiatives impacting laboratory operations.
- Champion operational excellence and efficiency improvement activities across the Materials Assessment Labs.
Qualifications- Bachelor's degree in Chemistry, Pharmaceutical Sciences, Materials Science, Engineering, or related scientific discipline; advanced degree preferred.
- Demonstrated experience in laboratory operations, scientific program management, or laboratory leadership.
- Experience managing laboratory workflows, training programs, data systems, and operational processes.
- Knowledge of electronic laboratory notebooks (eLN), digital laboratory platforms, and data management systems.
- Strong project management, organizational, and problem-solving skills.
- Proven ability to lead cross-functional initiatives and manage competing priorities.
- Excellent communication, collaboration, and stakeholder management skills.
Additional Information- Position is full-time, first shift.
- Excellent full-time benefits, including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
