Bioanalytical Laboratory Operations Manager

Position Summary This position will ensure safe and effective operation of laboratories supporting regulated bioanalysis in a fast‑paced, dynamic environment in compliance with Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) regulations/guidances, as well as established safety and operational policies and protocols. Duties and Responsibilities Oversee equipment purchases, installation, and validation with inter‑departmental collaboration. Maintain all laboratory equipment, schedule routine maintenance, coordinate non‑routine maintenance and re‑validation, review documentation, and schedule repairs as needed. Ensure lab designees perform routine housekeeping and monitor compliance with established procedures. Monitor daily activities in the lab for compliance with GLP/GCLP, Good Documentation Practices (GDP), and 5S principles, including correct use of forms and other laboratory documentation, labeling, equipment use, and laboratory techniques. Work with lab personnel to address noncompliances and/or deviations and, as necessary, escalated to managers. Create/revise standard operating procedures (SOPs) and forms. Develop and deliver laboratory training programs covering operations, safety, techniques, and compliance; coordinate training staff, mentor new trainers, and evaluate and document trainee performance. Participate in Continuous Improvement initiatives by proposing and implementing procedural enhancements. Ensure laboratories remain properly stocked with common reagents and equipment and quarantine/remove unqualified or expired materials. Participate in lab audits and tours associated with internal, customer, and external regulatory agencies. Serve as equipment alarm emergency response team lead, creating and participating in after‑hours responder schedules and responding to alarms as necessary. Supervise junior staff performing maintenance of laboratory equipment (as required). Experience and Qualifications Bachelor's degree in biology or related field preferred; associate’s degree may be substituted with additional relevant experience. Minimum of 5 years experience in GLP and/or GCLP lab management; experience in a contract research organization strongly preferred. Minimum of 2 years supervisory/mentoring/management experience. Experience developing, delivering, and evaluating end‑user and train‑the‑trainer training. Minimum of 2 years hands‑on bench‑work experience highly preferred. Knowledge, Skills and Abilities Working knowledge of GLP/GCLP and GDP (ALCOA+) regulatory principles as applied to bioanalytical laboratories. Knowledge of immunoassay execution, validation, and sample analysis to support clinical/preclinical studies; basic understanding of PK, ADA, NAb, serology, and/or biomarker assays. Ability to work independently. Strong time‑management skills for planning, executing, and tracking multiple projects and priorities. Solid written and verbal communication skills. Ability to develop and evaluate options and implement solutions for complex problems. Strong attention to detail with demonstrated commitment to excellence and performance. Proficiency in MS Office Suite; experience with MS Project or enterprise‑level project management tool desired. Physical Demands Up to 30% of the time may be spent in a BSL‑2 laboratory; may involve standing and repetitive tasks such as pipetting. Ability to lift/move up to 25 pounds. Work Environment This position is performed in a traditional office environment with up to 30% of time spent in a laboratory environment that includes chemical and Biosafety Level 2 (BSL‑2) materials. May involve handling of BSL‑2 materials including human blood and/or blood products and may involve handling of pathogenic materials. Compensation Summary The annual base salary for this position ranges from $88,100 to $134,400. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non‑discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success. Benefits Summary At MSD, we offer a comprehensive benefits package to support our employees' well‑being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company‑paid short‑ and long‑term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance. EEO / AA Statement MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please visit MSD's website. 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