Sr. Director/Director, Biorepository and Laboratory Operations

Summary

Our client is accelerating personalized medicine research by empowering

patients with their healthcare data and making it as easy as possible for them

to participate in the medical research process. They partner with patients and

pharmaceutical companies to accelerate precision medicine R&D by securely

and efficiently collecting and providing patient samples and relevant health

data. They are helping thousands of researchers at 20 of the top 40 global

pharmaceutical and biotechnology companies increase the speed and quality at

which they are conducting their research. For the past three years, our client

received the prestigious designation as a “Great Places to Work” company.

Duties / Expectations of Role

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 the company. This role is responsible for ensuring compliance with all relevant policies, procedures, guidelines, and all other regulatory and accreditation standards.

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

·Analytical services: Cell and cytokine profiling, protein counts, cell and tissue culture, functional cell assays, cytogenetic analysis, and analysis of microRNA expression

·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

·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

·Incorporates results of Quality audits in the improvement and enhancement of services

·Communicates results of Lab Quality processes to other stakeholders as necessary to improve lab and organizational performance

·Maintains knowledge and utilizes appropriate resources to provide regulatory, consultative, educational, technical, or informational services as needed to stakeholders

·Documents all significant activities and takes corrective action as necessary

·Ensures that the lab environment is clean, safe, and free from hazards for staff and guests

·Monitors relevant literature for new functions and products

Financial Management

·Contributes to the operating budget and adheres to budget throughout the year

·Conducts variance analyses; identifies and explains trends

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

·Reconciles statistics and adheres to revenue management standards

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

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

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

·Develops and participates in facility changes and planning

Mandatory Requirements

·PhD or MSc degree or equivalent in one of the biological sciences

·8+ years of laboratory and people management experience for a commercial laboratory operation such as at a central laboratory, commercial biorepository, industry partner (eg: pharma/biotech), and/or CRO

·3+ years of biorepository management experience

·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 that includes proven experience in leukopak processing and cryopreservation

·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

Preferred Requirements

·Stem cell experience (eg: iPSC services) and/or flow cytometry experience

·Hands-on experience or expertise for the following:

·Immunohistochemistry / Histology

·Next generation sequencing

·Molecular assays/techniques

·FDA/CLIA regulations

·Lean Six Sigma Certification

·Project Management Professional (PMP)

·Technologist/Scientist ASCP Certification or equivalent (BB, C, CG, CT, H, HTL, MLS, M, MB)

Term & Start

·Direct hire

·San Diego, CA; Maryland or Boston, MA that may include up to 25% of travel

·Remote is ok with 25-50% travel to labs and sites around the US