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 neededIncorporates 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 developmentIdentifies and manages external laboratory partners for extension of servicesWorks 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 neededDevelops 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 neededMay 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 / guidelinesMay identify, recommend, and act upon business opportunities related to laboratory services in collaboration with the leadership teamQualityCollaborates with Quality department to :Develop and maintain a quality management system which allows for consistent evaluation and improvement of services and productsEstablish ongoing quality data collection systems which enable monitoring of service levelsWorks 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 regulationsIncorporates results of Quality audits in the improvement and enhancement of servicesCommunicates results of Lab Quality processes to other stakeholders as necessary to improve lab and organizational performanceMaintains knowledge and utilizes appropriate resources to provide regulatory, consultative, educational, technical, or informational services as needed to stakeholdersDocuments all significant activities and takes corrective action as necessaryEnsures that the lab environment is clean, safe, and free from hazards for staff and guestsMonitors relevant literature for new functions and productsFinancial Management
Contributes to the operating budget and adheres to budget throughout the yearConducts variance analyses; identifies and explains trendsEstablishes programs to monitor and control costs in relation to volume and pre-established targetsReconciles statistics and adheres to revenue management standardsMaintains productivity standards; organizes and manages staff variable in relation to volume, service, and financial goalsParticipates in the negotiation of pricing / terms for supplies and maintenance agreementsDevelops major equipment purchase proposals, selection, prepares documents for equipment acquisition and leads the negotiation processDevelops and participates in facility changes and planningMandatory Requirements
PhD or MSc degree or equivalent in one of the biological sciences8+ 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 CRO3+ years of biorepository management experienceProven P&L experience and a track record of successKnowledge of laboratory regulations and experience implementing laboratory infrastructure in accordance with CAP and GLPExpertise in biorepository management and cell-based services / assays that includes proven experience in leukopak processing and cryopreservationStrong technical, operations, and people management skills that includes the ability to think strategically and from a commercial perspectiveExcellent communication and organizational skills - strong project management skills and must be able to collaborate with internal and external stakeholdersDemonstrated progressive leadership / management experienceDemonstrated leadership skills and ability to achieve resultsDemonstrated ability to effectively communicate across multidisciplinary departmentsProblem solving and decision-making skills, ability to appropriately confront and resolve issuesAbility to build teams, motivate individuals and groupsAbility to plan, organize and direct the activities of othersAbility to communicate well and drive change across the organizationDemonstrated sound, logical decision-making abilitiesOrganized and operates effectively without significant day-to-day oversight, while following senior leadership’s high level instructions and staying tightly connected to key stakeholdersPreferred Requirements
Stem cell experience (eg : iPSC services) and / or flow cytometry experienceHands-on experience or expertise for the following :Immunohistochemistry / HistologyNext generation sequencingMolecular assays / techniquesFDA / CLIA regulationsLean Six Sigma CertificationProject Management Professional (PMP)Technologist / Scientist ASCP Certification or equivalent (BB, C, CG, CT, H, HTL, MLS, M, MB)Term & Start
Direct hireSan Diego, CA; Maryland or Boston, MA that may include up to 25% of travelRemote is ok with 25-50% travel to labs and sites around the US