Bioanalytical Laboratory Operations Manager

MSD Careers•Gaithersburg, MD

About The Position

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. This position is responsible for overseeing and coordinating bioanalytical laboratory operations including maintenance and sourcing of laboratory equipment, conducting laboratory-related training activities, and logistics/supply management.

Requirements

Bachelor’s degree in biology or related field preferred o Associate’s degree may be substituted with additional relevant experience.
Minimum of 5 years of experience in GLP and/or GCLP lab management is required; experience in a contract research organization is strongly preferred
A minimum of 2 years of supervisory/mentoring/management experience is required
Experience developing, delivering, and evaluating end user and “train the trainer” training.
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.
Demonstrated ability to work independently.
Strong time management skills for planning, executing and tracking multiple projects and priorities.
Solid communication (written and verbal) 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.
Up to 30% of the time may be spent in a BSL-2 laboratory, and may involve standing and repetitive tasks (e.g., pipetting)
Ability to lift/move up to 25 pounds
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. May involve handling of pathogenic materials.

Nice To Haves

A minimum of 2 years of hands on benchwork experience is highly preferred.

Responsibilities

Oversees equipment purchases, installation, and validation with inter-departmental collaboration.
Oversees the maintenance of all laboratory equipment to include but not limited to scheduling of routine maintenance, coordinating non-routine maintenance and re-validation, reviewing associated documentation, and scheduling of repairs as needed.
Oversees lab designees performing routine housekeeping and monitors compliance to established procedures.
Monitors daily activities in the lab for compliance with established procedures, as well as GLP/GCLP, Good Documentation Practices (GDP), and 5S principles, including correct use of forms and other lab documentation, labeling of materials, use of equipment, and lab techniques.
Works with lab personnel to address noncompliances and/or deviations and escalates to managers, as necessary.
Creates/revises standard operating procedures (SOPs) and forms.
Develops and delivers laboratory training programs covering operations, safety, techniques, and compliance; coordinates training staff, mentors new trainers, and evaluates and documents trainee performance.Participates in Continuous Improvement initiatives by proposing and implementing procedural enhancements.
Ensures laboratories remain properly stocked with common reagents and equipment and ensures proper quarantine/removal of unqualified or expired materials.
Participates in lab audits and tours associated with internal, customer, and external regulatory agencies.
Serves as equipment alarm emergency response team lead, creating and participating in the after hours respondant schedule and responsing to alarms, as necessary.
May supervise junior staff performing maintenance of laboratory equipment.

Benefits

comprehensive benefits package to support our employees' well-being and financial security
competitive salaries
medical, dental, and vision coverage, along with prescription benefits
401(k) plan with company matching
flexible spending accounts
company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance
paid vacation
paid sick leave
paid holidays
paid parental leave
employee assistance program
fitness club membership contribution
pet insurance
identity theft protection
home and auto insurance discounts
optional supplemental life insurance