Biotech Process Development Jobs in Waterbury, CT

The Histology Lab Manager supports and advances the capabilities of Virscio’s preclinical histopathology program. This position is responsible for performing a broad range of routine and specialized histology procedures, leading assay development and validation activities with minimal guidance, maintaining high quality laboratory operations, and serving as a technical resource within the department. The Histology Lab Manager works independently while collaborating closely with the Histology Director, pathologists, histotechnologists, scientists, and study teams to ensure the delivery of high-quality histologic and molecular pathology data. Flexibility, technical expertise, attention to detail, and a commitment to continuous improvement are essential.

Work Location

Onsite New Haven

None

Type of Role

Full Time (40 hours per week)

Essential Supervisory Responsibilities

• Oversight of histotechnologist work quality and schedule
• Leadership:Serve as a technical lead for histology laboratory operations and provide training, guidance, supervision, and mentorship to junior laboratory staff and histotechnologists.
• Operations: Perform independent gross trimming, tissue processing, embedding, microtomy, cryosectioning, and routine histologic staining procedures, coordinate procurement, inventory management, and qualification of laboratory supplies, reagents, and consumables.
• Method development & optimization: Perform and optimize advanced histology techniques, including monoplex and multiplex immunohistochemistry (IHC) and immunofluorescence (IF), in situ hybridization (ISH), special stains, and digital pathology workflows. Participate in the development, optimization, validation, and implementation of new assays, methodologies, and laboratory technologies.
• Maintenance: Operate, maintain, troubleshoot, and perform quality control activities for histology instrumentation, including tissue processors, embedding centers, microtomes, cryostats, autostainers, and whole-slide scanners.
• Quality control: Review histologic preparations for technical quality and identify, investigate, and resolve processing, sectioning, staining, and imaging artifacts.
• Documentation: Maintain accurate study documentation, laboratory records, quality control logs, equipment maintenance records, and regulatory documentation.
• Quality Systems: Assist with preparation and review of Standard Operating Procedures (SOPs), work instructions, and laboratory training materials. Participate in laboratory process improvement initiatives designed to enhance quality, efficiency, reproducibility, and operational excellence. Support internal and external audits and inspections. Support laboratory compliance with good laboratory practice (GLP) and other applicable regulatory and quality requirements, as appropriate.
• Capability Expansion : Collaborate with scientific and pathology staff to support preclinical research studies and client-sponsored programs.

Qualifications

• Education level/Certifications/Licensures
• Bachelor’s degree in life sciences, such as biology, medical laboratory science, histotechnology or a related field.
• HT(ASCP) or HTL(ASCP) certification preferred.
• Experience
• Minimum of 5 years of histology laboratory experience, preferably in a preclinical pharmaceutical, biotechnology, or CRO setting.
• Specific competencies
• Demonstrated expertise in tissue processing, embedding, microtomy, cryosectioning, and histochemical staining techniques.
• Experience with advanced assays including IHC, multiplex IHC/IF, ISH/RNAscope, digital pathology, and image analysis platforms preferred.
• Experience troubleshooting histology workflows and laboratory instrumentation.
• Experience working within regulated environments (GLP, GCP, CAP, CLIA, or equivalent) preferred.
• Microsoft Word, Excel, and PowerPoint proficiency
• Strong communication skills, attention to detail, commitment to professional growth, and ability to collaborate with local and remote team members.
• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.
• Excellent written and verbal communication skills and demonstrated ability to collaborate effectively with cross-functional teams.
• Demonstrated commitment to scientific excellence, quality, and continuous professional development.
• ~5% to attended conferences or periodic visits to in-life testing facility