Job Summary
Join our growing company! This is a senior level, full time, position with opportunity to be an active team member at Prolacta. We are looking for an individual that can establish a CLIA laboratory to provide direct testing of human milk for both pooling and manufacturing QC and to provide clinical feedback to our donors in case of any rejected milk specimens at Prolacta.
Career Opportunities
- The CLIA Laboratory Director (LD) is responsible for overall oversight of the CLIA Laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for ensuring compliance with the applicable regulations and accreditation requirements.
- The LD may delegate certain responsibilities to other properly trained staff, but nonetheless has ultimate responsibility to ensure that all delegated duties are properly performed. This outgoing individual will provide leadership to and coordinate the company testing, assay validation and R&D support functions. This position reports to the Sr. Director of Quality and collaborates with the QC Lab Manager.
- CLIA Lab Director will review SOPs and sign off on changes, monthly quality control logs, and perform all other appropriate responsibilities as dictated by CLIA. The CLIA Lab Director completes these functions through a combination of remote and on-site involvement. NOTE: Most monthly tasks can be completed remotely, but, Lab Director will be on-site monthly, quarterly and for inspections as requested.
- CLIA Lab Director will review SOPs and sign off on changes, monthly quality control logs, and perform all other appropriate responsibilities as dictated by CLIA. The CLIA Lab Director completes these functions through a combination of remote and on-site involvement. NOTE: Most monthly tasks can be completed remotely, but, Lab Director will be on-site monthly, quarterly and for inspections as requested.
Who Are You?
The Lab Director must have experience in clinical molecular laboratory techniques and proven management skills for developing our LDT (Laboratory Developed Test), Direct Testing of Milk (DTOM) by qPCR, in accordance with CLIA and CAP standards and regulations. The Laboratory Director should be licensed in states where donor milk is collected if required by state law.
As the CLIA Laboratory Director, you will be an active member of Prolacta while overseeing the final validation of the DTOM Lab Developed Test, prepare validation documentation for appropriate regulatory bodies, and provide clinical and technical oversight for the testing and reporting of results. You will be a trusted partner, proactively anticipating business needs to be able to support our team, leaders, and the clients we support.
At Prolacta, your opinion matters. The right person for this role is a natural leader and enjoys working with an energetic and growing team. If you thrive working in a dynamic environment and being a true thought partner, then this is a great role for you.
Primary Duties and Responsibilities
- Responsible for implementing a quality system approach to laboratory testing which is consistent with the Prolacta corporate values.
- Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post analytical phases of testing
- Provide technical expertise and support for training CLS staff while ensuring continued compliance with regulations
- Responsible for CA State CLIA Laboratory licensure, NYS Laboratory licensure, and others as applicable.
- Lead technical team in preparation and submission of Laboratory Developed Test validations to CA and NYS and others as required.
- Ensure accurate and effective communication of laboratory data and appropriate patient result reporting to authorized recipients
- May serve as the clinical consultant regarding the ordering of appropriate tests and clinical significance of laboratory data, as appropriate
- Regularly attends meetings to discuss the management and operation of the laboratory
- Interacts with the QC lab manager to provide insights for continuous improvements
- Reviews and approves the technical performance validation and verification reports for new tests, instruments, and methods prior to their being used for donor samples testing according to the requirements specified in CAP s Molecular Pathology Checklist and other relevant CAP checklists
- Responsible for implementation, review, and documentation of CAP or other accredited proficiency program
- Has responsibility and authority to implement and maintain the College of American Pathologists (CAP) standards
- Ensures accurate and effective communication of laboratory data and appropriate result reporting to authorized recipients. May serve as the clinical consultant regarding the ordering of appropriate tests and clinical significance of laboratory data, as appropriate.
- Maintain a safe, efficient, functional and compliant laboratory operational environment developed to the required standards in accordance with corporate guidelines and staff qualification program
- Coordinate testing schedules with the QC Supervisor or QC Lab Manager for daily operations of the CLIA laboratory including incoming raw materials, testing, screening and release of milk donations.
- Coordinate activities with the Lab Manager, Planning, Manufacturing and Quality Assurance to ensure production schedules are met.
- Review and approve investigations related to the CLIA laboratory including OOS and nonconformance investigations,
- Streamline and standardize various laboratory processes to improve efficiency, accuracy and responsiveness.
- Assist in identification and qualification of outside testing laboratories and raw material vendors
- Collaborate with the Sr. Director of Quality, FP&A and Lab Manager to develop short and long term plans to support Prolacta’s Strategic Imperatives, including staffing, infrastructure and equipment plans
Job Requirements and Qualifications
Requirements
Licensure:
- The LD of an CLIA lab in California must be one of the following: 1) Board Certified Pathologist with a CA Medical License 2) Any MD with a CA Medical License and at least two years in laboratory specialty training (30 semester hours or equivalent in , or, 3) a PhD with a CA specialist Director license (Board certified and 3 yrs experience in molecular genetics, molecular pathology, virology, molecular microbiology or related field.
- The LD of a CLIA lab for New York patients must have a current license as a lab director issued by the state the laboratory is in (e.g. California) ; be an MD or DO licensed in that state, or a PhD in chemical, physical, biological or clinical lab science and be certified by an appropriate board; LD must obtain NYS Certificate of qualification in Molecular Pathology (4 yr post doc training or two years in specialty training and 2 years general lab management in the past six years). Renewable every two years.
- The CLIA Laboratory Director (LD) shall satisfy the applicable federal and state requirements for high complexity testing as described in:
- 42 CFR Subpart M Part 493.1443, Laboratory Director Qualifications
Qualifications
- Experience with LIMS and laboratory automation highly desired.
- Computer literate with advanced levels of experience using the following: Excel, Word, PowerPoint to generate business reports and presentations.
- Detailed knowledge of quality fundamentals, quality control, and quality management systems, including laboratory investigational tools
- Experience with presenting information to the Regulatory Authorities
- Experience with Operational Excellence in fast moving laboratory and/or manufacturing environment
- Experience with project management and statistical analysis
- Strategic planning experience
- Able to create and manage budgets, including capital planning and long-term strategic planning
- Effectively interview and select candidates
- Handle conflict management and bring resolution
- Effective relationship building skills
- Ability to produce and present clear, concise and professionally written communications and presentations
- Performance Management, effective coaching and directing of others
- Ability to operate in a complex matrix environment
- Scorecard Management
Other Knowledge, Skills and Abilities
- Must be detail oriented, organized, with excellent verbal and written communication skills.
- Visionary and forward-thinking
- High level of business acumen
- Strong Critical thinking and decision-making skills
- Strong business ethics
- Able to work effectively with others and able to deliver on tight deadlines.
- Positive attitude and motivation
Work Environment (Location, travel, shift, on-call, etc.)
Travel
- Minimal- determined through the needs of the business
Location
- City of Industry, CA
- Duarte, CA
Schedule
- Monday – Friday (8 hours)
- FLSA Status: Exempt
Direct Reports
- Responsible for the direction of staff performing CLIA testing
Who Are We- Prolacta Bioscience?
Company Summary
Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement for human breast milk and, as such, we believe infant nutritional products should be human milk- based. As a privately held, scientifically driven company, committed to improving premature infant nutrition, we are using human milk to change the standard of care in the NICU. Prolacta operates and/or owns milk banks that provide the starting material for the products Prolacta sells.
Mission Statement
We discover, develop, and deliver life-changing solutions for critically ill babies and other vulnerable patients. We achieve this through innovative human milk research and leadership in quality and safety.
Vision Statement
Giving babies a brighter future by unlocking the biological power of human milk
Company Values
- Leads the Industry in Quality and Safety
- Succeed Together
- Advance the Science of Human Milk
- Improve Infant Well-Being
Physical Requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to walk, sit, use hands and fingers to handle, or feel and reach, talk or hear. The employee is occasionally required to taste, smell, stoop, kneel, crouch or crawl. Employee will frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
Sedentary to light work; walking; talking; hearing; repetitive motions; stooping; kneeling; reaching; walking; pushing; pulling; visual acuity to prepare and analyze data and figures, transcribe, view a computer terminal.
Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people 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.
“Prolacta Bioscience, Inc. is an Equal Employment Opportunity Employer.” Prolacta Bioscience, Inc. is committed to a proactive program of affirmative action and diversity development. The Company will continue to recruit, hire, train, and promote into all job levels without regard to race, religion, gender, marital status, familial status, national origin, age, mental or physical disability, sexual orientation, gender identity, source of income, or veteran status.