Laboratory Director

Purpose, Scope and Dimension of Position:

The Director, Laboratory and Biorepository is responsible for maintaining the Standards for Biorepository Accreditation, implementing the requirements of the Accreditation Checklists, and documenting compliance.

Supervisory Responsibilities:

Directs the US Biolab Laboratory and Biorepository Departments.

Essential Duties/Major Accountabilities:

• Management and Operations
• Assures managers plan staffing requirements, hire to meet needs and schedules to ensure efficient management of resources and work flow
• Develops systems for alternative uses of staff
• Assists with development of talent across sections in technical/clinical and management positions
• Utilizes company resources to implement policies/procedures
• Assures Human Resource standards are applied fairly and consistently throughout the department
• Facilitates a multi-disciplinary and collaborative approach to interdepartmental problem-solving/service delivery
• Creates an environment of high morale and motivated team members
• Oversees laboratory protocol development and process improvement and project/grant development and management
• Implements and oversees laboratory infrastructure for commercial biorepository and laboratory services
• Biorepository services: Biospecimen processing and storage with human whole blood and leukopaks including its derivatives which may include serum, plasma, DNA, RNA, and immune cell subtypes
• Processing and storage of other biological and tissue materials such as urine, FFPE blocks and tissue samples, and other human biospecimen types
• Develops best-in-class biospecimen sample logistics that include sample storage, data transfer/management, shipping, tracking, reconciliation, and processing to achieve business goals and quality targets
• Collaborates with IT and QA to implement an effective sample traceability process through the LIMS that includes eCommerce sample inventory management
• Evaluates and leverages standard and/or emerging technologies to optimize or implement laboratory processes with a strong understanding of prioritization, ROI, and tradeoffs
• Vendor management responsibilities with external laboratory service providers and may work directly with the project manager on study deliverables
• Troubleshoots and proactively works with laboratory staff and relevant stakeholders to ensure issues are resolved in a timely manner
• Commercial and Growth
• Contributes to the overall strategy and direction of biorepository services and keeps abreast of current activities in the field while evaluating and implementing changes as needed
• Incorporates staffing needs, budgets, growth projections, program timelines, space and equipment footprint, and/or needs for sharing/segregation into a long-term, flexible space allocation plan.
• Involved in the growth, expansion, and implementation of new laboratory services and/or site development
• Identifies and manages external laboratory partners for extension of services
• Works with the commercial team and can serve as a top level client contact for laboratory deliverables that may include study design consultation and/or client troubleshooting, and will join sales/client calls as needed
• Develops experimental and quality data and reports for customer assets for sales and marketing purposes (videos, one pagers, etc) and works with Product and Marketing teams to develop customer support materials as needed
• May assist with development of client services and support infrastructure that includes the development of FAQs and training for internal teams and external parties in regards to new services, procedures, and policies/guidelines
• May identify, recommend, and act upon business opportunities related to laboratory services in collaboration with the leadership team
• Quality: Collaborates with Quality department to:
• Develop and maintain a quality management system which allows for consistent evaluation and improvement of services and products
• Establish ongoing quality data collection systems which enable monitoring of service levels
• Work with the laboratory manager/supervisor and QA team to incorporate a comprehensive quality and training program that includes SOPs, CoAs, training records and oversight, and implementation of quality testing programs in accordance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and other relevant regulations
• Incorporate results of Quality audits in the improvement and enhancement of services
• Communicate results of Lab Quality processes to other stakeholders as necessary to improve lab and organizational performance
• Maintain knowledge and utilizes appropriate resources to provide regulatory, consultative, educational, technical, or informational services as needed to stakeholders
• Document all significant activities and take corrective action as necessary
• Ensure that the lab environment is clean, safe, and free from hazards for staff and guests
• Monitor relevant literature for new functions and products
• Financial Management

a. Contributes to the operating budget and adheres to budget throughout the year

b. Conducts variance analyses; identifies and explains trends

c. Establishes programs to monitor and control costs in relation to volume and pre-established targets

d. Reconciles statistics and adheres to revenue management standards

e. Maintains productivity standards; organizes and manages staff variable in relation to volume, service, and financial goals

f. Participates in the negotiation of pricing/terms for supplies and maintenance agreements

g. Develops major equipment purchase proposals, selection, prepares documents for equipment acquisition and leads the negotiation process

h. Develops and participates in facility changes and planning

5..Miscellaneous

• Maintain a clean personal workspace.
• Maintain confidentiality of all US Biolab business.
• Take on other duties as assigned or required by management when needs arise.

Accountability Standards for all Department Staff:

• Dependability, reliability, flexibility, adaptability, integrity and communication.
• Ability to function successfully in a team setting and assist co-workers with departmental workflow as directed by the Chief Operating Officer.

Minimum Required Knowledge, Skills and Abilities:

• PhD or MSc degree or equivalent in one of the biological sciences
• 4 or more years of full-time general laboratory training and experience, of which at least two years were spent acquiring proficiency in biorepository operations and management.
• Proven P&L experience and a track record of success
• Knowledge of laboratory regulations and experience implementing laboratory infrastructure in accordance with CAP and GLP
• Expertise in biorepository management and cell-based services/assays.
• Strong technical, operations, and people management skills that includes the ability to think strategically and from a commercial perspective
• Excellent communication and organizational skills - strong project management skills and must be able to collaborate with internal and external stakeholders
• Demonstrated progressive leadership/management experience
• Demonstrated leadership skills and ability to achieve results
• Demonstrated ability to effectively communicate across multidisciplinary departments
• Problem solving and decision-making skills, ability to appropriately confront and resolve issues
• Ability to build teams, motivate individuals and groups
• Ability to plan, organize and direct the activities of others
• Ability to communicate well and drive change across the organization
• Demonstrated sound, logical decision-making abilities
• Organized and operates effectively without significant day-to-day oversight, while following senior leadership’s high level instructions and staying tightly connected to key stakeholders

Additional Preferred Qualifications:

• Proficient in Microsoft Office/365, Teams, SharePoint, Salesforce, other.
• Excellent personal relations skills; able to explain procedures in a step-by-step manner.

Physical Requirements:

• Must be able to remain in a stationary position for prolonged periods.
• Must be able to lift and move items up to 10 pounds.
• Must be able to tolerate frequent exposure to a wide variety of chemicals which are common to the research industry. Must be able to wear appropriate personal protective equipment if/when handling samples or materials.

Hours/Schedule

• This position is primarily remote with on-site requirement at least one day per month and available remotely as need basis