Director Of Laboratory Operations - Simply Biotech

Overview
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a Director of Laboratory Operations with a biopharmaceutical company in San Diego, CA who possesses:

• Managerial experience
• Must be willing to travel 50% of the time
• Hands on experience with flow cytometry
• Must have experience in lab working with blood, PBMCs, etc.
• PhD, Master's Degree or equivalent in biological sciences

Email resumes to [email protected] or call 469.895.5515
FULL DESCRIPTION: The Laboratory Director will function as a leader, innovator, coordinator, and change agent in the pursuit of improved operations, and is accountable for managing (planning, organizing, staffing, influencing, and controlling) all components of the Laboratory. Additionally, the Laboratory Director manages onsite team(s) of Lab manager(s), Lab technician(s), and Project Manager(s) while upholding the organization's Code of Conduct. This position is responsible for creating, designing, and implementing systems, processes and policies while maintaining the mission, vision, and values of our client. This role is responsible for ensuring compliance with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.
Management And Operations
The selected candidate will be responsible for:

• Develops systems for alternative uses of staff
• Collaborates with IT and QA to implement an effective sample traceability process through the LIMS that includes eCommerce sample inventory management
• Assures Human Resource standards are applied fairly and consistently throughout the department
• Vendor management responsibilities with external laboratory service providers and may work directly with the project manager on study deliverables
• Assists with development of talent across sections in technical/clinical and management positions
• Troubleshoots and proactively works with laboratory staff and relevant stakeholders to ensure issues are resolved in a timely manner
• Utilizes company resources to implement policies/procedures
• Creates an environment of high morale and motivated team members
• 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
• Oversees laboratory protocol development and process improvement and project/grant development and management
• 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
• Implements and oversees laboratory infrastructure for commercial biorepository and laboratory services
• Analytical services: Cell and cytokine profiling, protein counts, cell and tissue culture, functional cell assays, cytogenetic analysis, and analysis of microRNA expression
• Facilitates a multi-disciplinary and collaborative approach to interdepartmental problem-solving/service delivery
• Evaluates and leverages standard and/or emerging technologies to optimize or implement laboratory processes with a strong understanding of prioritization, ROI, and tradeoffs
• Assures managers plan staffing requirements, hire to meet needs and schedules to ensure efficient management of resources and workflow
• Processing and storage of other biological and tissue materials such as urine, FFPE blocks and tissue samples, and other human biospecimen types

Commerical And Growth

• May identify, recommend, and act upon business opportunities related to laboratory services in collaboration with the leadership team
• 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
• 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 regard to new services, procedures, and policies/guidelines
• 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.
• 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
• Develops experimental and quality data and reports for customer assets for sales and marketing purposes (videos, one pager, etc.) and works with Product and Marketing teams to develop customer support materials as needed
• 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

Quality

• Monitors relevant literature for new functions and products
• Establish ongoing quality data collection systems which enable monitoring of service levels
• Documents all significant activities and takes corrective action as necessary
• Develop and maintain a quality management system which allows for consistent evaluation and improvement of services and products
• Maintains knowledge and utilizes appropriate resources to provide regulatory, consultative, educational, technical, or informational services as needed to stakeholders
• Communicates results of Lab Quality processes to other stakeholders as necessary to improve lab and organizational performance
• Collaborates with Quality department to:
• Incorporates results of Quality audits in the improvement and enhancement of services
• Works 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
• Ensures that the lab environment is clean, safe, and free from hazards for staff and guests

Financial Management

• Reconciles statistics and adheres to revenue management standards
• Develops major equipment purchase proposals, selection, prepares documents for equipment acquisition and leads the negotiation process
• Maintains productivity standards; organizes and manages staff variable in relation to volume, service, and financial goals
• Establishes programs to monitor and control costs in relation to volume and pre-established targets
• Participates in the negotiation of pricing/terms for supplies and maintenance agreements
• Develops and participates in facility changes and planning
• Conducts variance analyses; identifies and explains trends
• Contributes to the operating budget and adheres to budget throughout the year

The Selected Candidate Will Also Possess

• Strong technical, operations, and people management skills that includes the ability to think strategically and from a commercial perspective
• Demonstrated sound, logical decision-making abilities
• Excellent communication and organizational skills - strong project management skills and must be able to collaborate with internal and external stakeholders
• Ability to communicate well and drive change across the organization
• Ability to plan, organize and direct the activities of others
• 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
• Proven P&L experience and a track record of success
• Problem solving and decision-making skills, ability to appropriately confront and resolve issues
• Ability to build teams, motivate individuals and groups
• Expertise in biorepository management and cell-based services/assays that includes proven experience in leukopak processing and cryopreservation
• Demonstrated leadership skills and ability to achieve results
• Knowledge of laboratory regulations and experience implementing laboratory infrastructure in accordance with CAP and GLP
• Demonstrated progressive leadership/management experience
• Demonstrated ability to effectively communicate across multidisciplinary departments

Salary Range: $150k-$180k/yr
For immediate and confidential consideration, please email your resume to [email protected] or call 469.895.5515. More information can be found at www.simplybiotech.com