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The Company is seeking an individual with broad-based histology, tissue, and materials analysis experience. The candidate will play an important role in executing a science-driven strategy to support Dermagraft and Vascugel process improvements and product characterization, and to provide support for expanding and strengthening the clinical and non-clinical data portfolio in support of existing and future regenerative medicine products. This position will be based in La Jolla, CA.
The individual will be responsible for establishing, managing and maintaining a histology core site within the R&D laboratory at Shire Regenerative Medicine (SRM) in La Jolla. The role will require execution of tissue and materials processing for histological analysis, including simple and differential staining, immunohistochemistry, immunofluorescence and in situ hybridization to support SRM existing and future product characterization and process improvements. The individual will also play a key role in the histological analyses of clinical and non-clinical specimens derived from studies conducted to advance the company’s understanding of product mechanism of action and submit data in support of the company’s regulatory filings and scientific publication strategy. The individual will be expected to maintain the facility and equipment in the histology core facility to ensure continuous laboratory operations including interaction with internal support staff and external vendors.
-Conducts research studies with minimal supervision involving tissue processing, immunohistochemistry, immunofluorescence and in situ hybridization to support department goals and meet corporate deadlines.
-Establishes and manages histology core facility at La Jolla SRM site including histology equipment maintenance, calibration and services to ensure continuous laboratory operations.
-Trains laboratory interns and staff on the standard operation of histology equipment and techniques as necessary.
-Organizes and maintains searchable inventories of histology data and good documentation for use by laboratory personnel and review by outside agencies.
-Drafts reports summarizing in-house non-clinical laboratory studies, including, study protocols, test procedures, and standard operating procedures related to non-clinical laboratory research efforts to support process and product development efforts including filings with regulatory agencies.
-Communicates study progress both in oral and written formats at department and company meetings.
Education and Experience Requirements
-The position requires a Bachelor’s degree or higher in a biological discipline with at least 6 years experience working in and managing a histology laboratory setting, preferably for a biotechnology, medical device, or clinical pathology company. ASCP certification and experience working in a CLIA or GLP compliant work environment preferred.
-This position will be hands-on and will require the individual to conduct embedding, sectioning and staining of tissue specimens received from non-clinical and clinical studies. This individual will interact closely with R&D and Technical Operations staff to ensure that department goals are executed in a timely manner and to the highest level of quality to support the Company’s strategic objectives.
Key Skills, Abilities, and Competencies
• Laboratory experience in soft-tissue histology including the preparation, sectioning, and staining of frozen and paraffin embedded tissue specimens.
• Operating knowledge and execution of projects using automated staining instrumentation for simple staining, immunohistochemistry and in situ hybridization
• Experience with confocal, bright-field and fluorescence microscopy
• Ability to work with minimal supervision to complete laboratory projects in a timely manner to meet department/ corporate deadlines
• In situ hybridization for the detection/ staining of gene expression in clinical and non-clinical tissues and cells
• Expertise in managing histology laboratory operations including purchasing lab supplies and equipment, maintenance and calibration of equipment, waste management and data archiving
• Expertise in creating and maintaining searchable histology records
• Experience with the use of imaging software for histomorphometic analysis.
• Management of outside contract histology worksites for completion of histology projects
• Management of laboratory interns
• Outstanding written and oral communication skills
• Experience writing scientific protocols/reports and standard procedures
Complexity and Problem Solving
-The individual will be expected to establish and develop methodologies related to the histological analysis of the company’s products, order the supplies required, and make recommendations for the purchase and maintenance of equipment to enhance the capabilities in the histology core facility. Capital equipment purchases will remain the responsibility of the managing Director in the department.
-Must have ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables, to ensure appropriate interpretation of histology outcomes.
-Must have ability to read, analyze, and interpret the most complex documents including scientific literature, and product related literature. Ability to clearly communicate and present research data to company management and co-workers in both oral and written formats.
Internal and External Contacts
Internally the role will require regular interaction with and accountability to scientific staff in the SRM R&D, Process Development, and Regulatory Affairs departments. The individual will also interact regularly with Facilities and EHS management to ensure the safe and efficient operation of the histology core facility. External contacts will include vendor/ suppliers of histology reagents, and equipment. The individual will also be expected to interact with and provide oversight for external contract histology sites conducting studies supporting the company’s clinical and non-clinical programs.
Other Job Requirements
The individual may be required to travel up to 5% of the time to interact with outside laboratories in support of the Company’s objectives.
Shire is an Equal Opportunity and Affirmative Action Employer