Pathology Laboratory Operations Manager

Irvine, California, United States | Full-time

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Position Overview:

Leader of laboratory operational team  who monitors, evaluates and supports all daily activities of the APS team to deliver CAP/CLIA and non-GLP oriented laboratory services offered by Invicro to external partners. Develops efficient and effective workflows to enable timely delivery of highly quality results to our customers. Resolves conflicts and acts as player coach

 

Key Responsibilities:

  • Participate in discussions with customers to establish scope of work / timeline / cost for proposed projects.
  • Perform development / testing / sourcing as required, for individual projects.
  • Manage daily team activities and scheduling. Monitors work to ensure timely completion.
  • Complete and update documentation to meet customer expectations.
  • Prepare and present project status updates to management team and sponsor(s).
  • Ensure all necessary documentation is in place to maintain compliance with CAP/CLIA accreditation requirements.
  • Design and execute validation protocols and compile all necessary documentation.
  • Perform histology, special stains, IHC and ISH testing.
  • Perform whole slide image capture and quantitative analysis according to project requirements.
  • Maintain inventory levels for required reagents and materials
  • Ensure maintenance of all equipment is completed and documented to required standards / service intervals.
  • Participate in CAP/CLIA audits, providing subject matter expertise for Histology and IHC.
  • Participate in departmental lab meetings acting as IHC subject matter expert.
  • Participate in relevant CAP Proficiency Testing as required.
  • Provide guidance and training to all staff on newly introduced assays or methodologies
  • Act as subject matter expert for technical questions regarding Histology IHC, ISH, IF and Imaging.

 

Qualifications and Skills:

  • Knowledge of clinical and research laboratory policies and procedures and laboratory standards to enable efficient and compliant functioning of department.
  • Ability to multi-task between regulated clinical procedures and RUO based projects
  • An understanding of standards and requirements of a CAP/CLIA accredited lab and experience in maintaining those standards.
  • Demonstrated ability to review and accurately assess qualitative aspects of IHC staining.
  • Able to troubleshoot staining issues involved with histology and IHC.
  • Knowledge of laboratory safety protocols.
  • Knowledge of laboratory equipment and determine needs. Identify and evaluate equipment for purchase.
  • Knowledge of relevant safety requirement. Provide instruction, recognize and correct hazardous conditions.
  • Demonstrated excellence in communication, managerial, and scientific tasks
  • Ability to interact effectively across cross-functional groups.
  • Proactively seeks to identify resource performance issues and proposes innovative solutions to multi-disciplinary teams and senior management
  • Knowledge of business methods including productivity/workload analysis and scheduling.
  • Skill in performing a range of laboratory tests and operating a variety of laboratory instrumentation and equipment, including routine Histology, special stains, IHC/ISH/IF, whole slide imaging
  • Skill in appropriate collection/analysis/presentation of staffing, productivity, and cost data on a routine and special-project basis.
  • Experience with Laboratory Information Management System (LIMS).
  • Proficiency utilizing typical software packages such as Microsoft Office Suite.
  • Skilled in personnel management including conflict resolution and motivation.
  • Ability to analyze workload requirements and schedule personnel appropriately.
  • Possess effective verbal, written, and interpersonal communication skills.
  • Highly organized and detail oriented.

 

Minimum Education and Experience:

  •  Minimum BS in a Biological or Life Science and HTL (ASCP) Certification.
  • 10+ years of histopathology laboratory experience in pharma, hospital or CRO
  • 5+ years in a supervisory or management role
  • Must be familiar with working with human and non-human tissues and the differing process applied to each to produce high quality results.

Preferred candidates will have a MS in a relevant scientific discipline, experience in LEAN thinking and how it can be applied to laboratory workflows. A demonstrated problem solver who creatively and knowledgeably performs in a high throughput research and clinical setting is also preferred. 

 

What We Offer
  • Competitive salary
  • 401k with generous matching
  • Flexible paid time off policy

 

Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.