Lab Supervisor 2

Merck • Rockville, MD

4d

About The Position

The Lab Supervisor 2 oversees laboratory assays and tests used to characterize product or material safety and supervises laboratory staff, including Associate Scientists and/or laboratory technicians. The role manages laboratory operations and metrics, maintains scientific documentation, and ensures work complies with applicable professional and industry standards and GxP requirements. The supervisor may serve as Study Director for GLP studies or as the responsible study-management person for release of GMP study results.

The position coordinates daily laboratory activities, assay and sample schedules, study initiation paperwork, and review of study data. It investigates deviations and nonconformances, works with Quality Assurance and cross-functional teams on corrective actions, maintains awareness of SOPs and cGMP/GLP regulations, and evaluates procedures and documentation for compliance. It also oversees scientific equipment, instrumentation, and computer systems to keep them calibrated or validated and Part 11 compliant; supports client and site visits and audit follow-up; and manages staff development, training, hiring, and performance reviews. The supervisor may participate in divisional quality, SOP, and Lean initiatives and perform other duties as required.

Requirements

• Master’s degree in a scientific discipline and at least 2 years of laboratory experience, or bachelor’s degree in a scientific discipline and at least 4 years of laboratory experience.
• At least 1 year of experience leading and training staff in a laboratory setting.

Nice To Haves

• Experience in a cell culture-based laboratory setting and PCR.
• Intermediate skills in applicable computer programs.
• Excellent verbal and written communication skills demonstrated through presentations or seminars, project oversight, implementation of new services, or similar work.
• Excellent time-management skills.
• Ability to work collaboratively and independently.
• Initiative and leadership capabilities.
• Effective supervisory, coaching, and training skills for complex and highly technical work.
• High technical competence.

Responsibilities

• Oversee assays and tests used to characterize product or material safety and supervise laboratory staff.
• Manage overall laboratory operations and metrics, and document scientific observations in accordance with professional and industry standards.
• Ensure compliance of studies with GxP principles; may act as Study Director for GLP studies or as the responsible person for release of GMP study results.
• Coordinate day-to-day laboratory activities, assay schedules, sample schedules, and paperwork required for timely study initiation.
• Review study data for accuracy, compliance, and completeness of documentation.
• Investigate deviations and nonconformances to determine root causes and document investigations promptly.
• Work with Quality Assurance and cross-functional departments to close events and corrective actions related to GxP laboratory testing.
• Stay current with SOPs and cGMP/GLP regulations and periodically evaluate laboratory procedures, system controls, SOPs, and batch records for compliance.
• Manage scientific equipment, instrumentation, and computer systems, ensuring they remain calibrated or validated and Part 11 compliant.
• Assist with technical and Quality Assurance site visits, complete client requests, and address visit or audit findings in a timely manner.
• Participate in client conference calls and anticipate or address client questions.
• Supervise staff by setting goals, holding regular one-on-one discussions, maintaining development plans, addressing personnel issues, interviewing and hiring candidates, and completing fair and timely performance reviews.
• Serve as the departmental training point of contact, keeping training modules current and the training matrix reflective of staff capabilities.
• Participate in division-wide initiatives, including quality-system improvements, trans-divisional SOP revisions, and Lean projects.
• Perform other appropriate or required duties.

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance
• 401(k) matching program
• Paid time off
• Paid holidays
• May be eligible for short-term or long-term incentive compensation, including cash bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Manager