See what we are all about: www.moleculartestinglabs.comPrimary Function: The Director of Research and Development is primarily responsible for leadership and oversight of the R&D team. This includes responsibility for maintaining the development, optimization and validation of innovative methods for all categories of our product portfolio. Meeting company development timelines is critical for new validations while also balancing R&D activities toward strategic product development. The Director of R&D leads analysis of data gathered for incorporation into a CAP/CLIA compliant validation.
Essential Duties and Responsibilities:
- Establish and oversee program direction and provide strategic direction, leadership, supervision, mentoring and technical guidance for Research Scientists and for projects that these scientists are leading.
- Work closely and effectively with the R&D team to ensure that all projects are progressing, and milestones are achieved pursuant to organization and/or client timelines
- Manage performance of assigned laboratory scientists and support staff and ensure program productivity and efficiency
- Work closely and effectively with Research Scientists and the production team to prioritize use of equipment and facilities for maximum productivity and efficiency
- Communicate effectively with both internal and external clients regarding scientific issues/projects
- Write verification/validation reports and SOPs in accordance with MTL's established guidelines
- Maintain and enhance R&D laboratory resources (personnel, facilities, equipment, and reagents)
- Ensure project cost objectives are met and communicated
- Serve as team member on various ongoing and future new test idea generation projects
- Develop and maintain an effective working relationship with clinical laboratory team to allow effective, coordinated assay transition from the R&D phase to clinical use
- Develop an effective working relationship with Regulatory Affairs/Quality Assurance to assure R&D laboratory is in compliance with MTL's established guidelines for documentation, quality and safety
- When appropriate, recruit and hire a sufficient number of qualified and trained laboratory assistants to maintain and support R&D activities
- When appropriate, conduct regular individual meetings with R&D Scientists that focus on execution of their respective responsibilities and project priorities
- Communicate program objectives to cross-functional teams (clinical laboratory, regulatory teams)
- Commitment to a high quality of work and at the same time maintain a high level of productivity
- Maintain current knowledge of advances in pertinent scientific fields, as well as knowledge of applicable state and federal regulations germane to molecular and diagnostic laboratories, through attending lectures, seminar, professional conferences and courses
- Regularly contribute to laboratory team meetings that focus on associate training, associate development and continuous improvement in laboratory processes
- When appropriate, identify and develop training programs for R&D Scientists and dedicated staff
- Preparation of poster presentations for national scientific meetings
- Prepare manuscripts for publication in peer reviewed journals
- Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times
- Active participation in team and company meeting
- Participate in developing corporate goals, objectives, and systems
- Other duties as assigned by management
Skills, Knowledge, Abilities:
Mental Abilities and Skills Requirements, Knowledge Needed:
- 8 years diagnostic and/or molecular or immunology research laboratory experience preferred
- At least 8 years of experience on assay development, validation and transition to a clinical environment required
- Expertise and experience in biochemistry, molecular biology/genomics, or immunology assay development, verifiable through patents, publication or description of completed projects required
- Minimum of 8 years of management or team/program leadership experience. Demonstrated proven experience in managing complex projects, ability to succeed even with challenging projects, appreciation of priorities and critical factors.
- Substantial technical writing experience: protocols, study reports, regulatory communications and manuscripts
- Able to think strategically and develop novel diagnostic products.
- An innovative and prepared mind to identify and protect unique intellectual properties is a bonus
- Commitment to and track record of high quality of work
- Experience with quality systems
- Ability to establish and maintain effective working relationships with other groups
- Goal oriented, with excellent time management and organizational skills
- Excellent interpersonal skills, with ability to interact effectively and work efficiently with people at all levels in an organization
- Excellent verbal & written communication skills
- Keenly attentive to detail
- Ability to keep sensitive information confidential
- High level of proficiency with PC based software programs
Education and Certification:
- Advanced degree in microbiology, immunology, biology, biochemistry or related field is required; PhD preferred
- PhD with a minimum of 8 years + of leadership experience in a Clinical Laboratory, PhD preferred
- Or Master's Degree with 15 years+ of leadership experience in a Clinical Laboratory
- Experience working in a CAP and/or CLIA clinical laboratory is preferred
- Must be able to sit or stand for up to 8 hours per day.
- Occasionally required to lift up to 20 lbs
- Regularly required to sit, stand, bend, reach and move about facilities.
VANCOUVER OFFICE - Most work will be performed in an office. However, this position may require some traveling and working between locations. Workweeks usually consist of 40 hours.
LAB POSITIONS - Most work will be performed in the lab. However, this position will require some traveling and working between locations. Workweeks usually consist of 40 hours.
Office Environment -
- Several common areas and meeting rooms for collaboration
- Large windows which let in natural light during working hours
- Fully equipped break room and bathrooms.
Lab Environment -
- Noise levels vary based on flow of business
- Most floors are tile or concrete - individuals may stand for extended periods of time on these surfaces
Tools and Technology:
- Desktop computer and laptop
- Scanners and printers
- Work is performed in an office environment, full manual dexterity and visual acuity required. However, access to the laboratory may be necessary and therefore employee may be exposed to potential physical harm from hazardous chemicals, infectious diseases, blood-borne pathogens, toxic materials, toxic gases, electrical hazards, dangerous tools and equipment.
- Hep B Vaccination provided at no cost to employee
The above statements are intended to describe the general nature and level of work being performed by associates assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Molecular Testing Labs embrace diversity and is an Equal Opportunity Employer, and hire without regard to any individual's race, age, color, national origin, ancestry, disability, veteran status, religion, marital status or domestic partnership; pregnancy, childbirth or related medical conditions; other medical conditions or genetic characteristic; sexual orientation, gender, gender identity or transgender status; or any other basis protected by state, federal or local law, regulation or ordinance. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Molecular Testing Labs provides reasonable accommodation upon job seeker request in all steps of the employment process.