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Laboratory Manager

BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America Req #143
Sunday, May 8, 2022
At BioAgilytix, we are passionate about premier science and the impact it has on our world. Our team of highly experienced scientists and professionals deliver tailored services for supporting new medicine breakthroughs with best-in-class bioanalytical services. We are tirelessly committed to our customers by being solution-oriented and deadline-driven. . . and we are growing. Our culture is fast-paced, fun and never boring. Because we work across numerous clients and drug modalities, your career can develop rapidly. You’ll gain experience with a variety of challenges all while you enable life-changing, life-saving therapeutics to the patients who need them.

Under general direction, the Laboratory Manager performs a wide variety of administrative tasks and responsibilities as well as assigned laboratory testing. The duties listed below are illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related or a logical assignment to the Laboratory Manager.

Essential Responsibilities

  • Schedule and supervise Laboratory Staff to meet or exceed productivity and quality goals.
  • Monitor quality control processes to ensure all activities meet the established criteria of acceptability.
  • Responsible for the day-to-day management, oversight, and competency of the laboratory personnel in the performance of test procedures and reporting test results promptly, accurately, and proficiently, and for ensuring compliance with applicable regulations.
  • Work in conjunction with Laboratory Management to support all laboratory related activities.
  • Work with the Quality Assurance Unit to monitor quality standards and regulatory requirements.
  • Monitor, assess, and review the efficiency and effectiveness of the laboratory.
  • Coordinate with Laboratory Technical Supervisor in monitoring performance standards and proficiency and competency levels for clinical Laboratory Staff.
  • Communicate changes in work scope to the Laboratory Technical Director to ensure appropriate planning measures are taken with internal personnel and external clients to reassess, renegotiate, and amend scope of work responsibilities, proposals, contracts, and budgets.
  • Oversees inventory control to ensure adequate supplies and availability of material necessary for testing.
  • Assist in the design of training programs, implementation, and monitoring of the effectiveness of technologist training.
  • Maintain laboratory paper and electronic records.
  • Proficient in Laboratory Information System (LIS).
  • Assist in the development of SOPs, Forms, and another laboratory documentation.
  • Work with staff and management to plan and formulate clinical goals and objectives.
  • Attend and conduct meetings of Clinical Laboratory staff.
  • Maintain a working knowledge of all assays.
  • Perform moderate and high complexity testing of patient samples on an as needed basis.
  • Maintain the skills necessary to develop laboratory procedures for high complexity analytes using a variety of technologies, as well as be able to troubleshoot problems arising during testing and has an awareness of the factors that can influence test results.
  • Assists in managing quality assurance programs including proficiency testing.

Human Resources Management

  • Ensure laboratory staff adherence to BioAgilytix Human Resource programs and policies such as holiday, leave requests, hours worked, and vacation scheduling, etc.
  • Takes part in administering annual Performance Reviews.
  • Reviews employee suggestions, complaints, and grievances and fosters an environment that encourages new ideas, and open constructive and clear communications.
  • Participates in recruitment, interview, and assessment of new talent for the laboratory.

Additional Responsibilities

  • Be responsible for supervising all activities in a clinical laboratory performing highly complex assays.
  • Allocate resources to ensure that the laboratory meets the production requirements while maintaining a quality level that meets CAP/CLIA/GLP/GCLP, New York State Department of Health CLEP regulatory requirements and the Commonwealth of Massachusetts state regulations as applicable for clinical labs.
  • Monitor and supervise the daily routine of laboratory personnel involved with testing, equipment, sample receipt, supplies and the review of Quality Control and Standard Operating Procedures.
  • Ensure that all facets of personnel, equipment, documentation, and procedures are compliant with regulatory agencies.
  • Possess the communication skills necessary to work with laboratory staff, scientists, and members of other organizational departments, clients, and company management.

Minimum Acceptable Qualifications

Education:

  • Position requires a minimum of a Bachelor’s degree in Medical Technology or related Life Science, and/or national certification as a Medical Technologist or Clinical Laboratory Scientist and/or fulfillment of the educational, experience and certification requirements of 42 CFR part 493.1461 as most recently posted in the Federal Register, and fulfillment of 10 NYCRR Subpart 58-1.4.c of the New York Laboratory Standards requiring 6 years of laboratory experience after qualifying as a Medical Technologist, and a minimum of 3+ years of combined experience supervising diagnostic laboratory performing highly complex assays.

Experience:

  • A strong knowledge of MS Office, including Word, Excel, PowerPoint, and Access and experience using LIS and Project Management software.
  • Knowledge of GLP, GCLP, CLIA, CAP, NYS DOH CLEP, the Commonwealth of Massachusetts and other applicable state and federal regulations for clinical labs.
  • The ability to interact effectively with all levels of staff in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful, and efficient with a high level of professionalism and confidentiality.
  • Strong written and verbal communication skills, decision making skills, and attention to detail.
  • The ability to manage multiple and rapidly changing priorities, organize, set priorities, and exercise sound independent judgment within areas of responsibility.
  • The ability to maintain highly sensitive and confidential information.
  • The ability to use a high degree of tact, discretion, and diplomacy in dealing with people.

Supervisory Responsibility

  • This position will supervise Clinical Diagnostic Laboratory along with the Laboratory Technical Supervisor.

Working Environment

  • Primarily laboratory/clinical environment
  • Occasional office work
  • Exposure to biological fluids with potential exposure to infectious organisms
  • Routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets
  • Rare exposure to skin and lung irritants, radiation, toxic materials, and hazardous waste
  • Personal protective equipment required, such as protective eyewear, garments, and gloves
  • Exposure to fluctuating and/or extreme temperatures on rare occasions

Physical Demands

  • Ability to work in an upright and/or stationary position for up to eight (8) hours per day
  • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment
  • Occasional mobility needed
  • Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
  • Light to moderate lifting and carrying (or otherwise moving) objects, including luggage and laptop computer, with a maximum lift of 20 pounds
  • Ability to access and use a variety of computer software
  • Ability to communicate information and ideas so others will understand, with the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Frequently interacts with others to obtain or relate information to diverse groups
  • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals; requires multiple periods of intense concentration
  • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence
  • Ability to perform under stress and multi-task
  • Regular and consistent attendance

Position Type and Expected Hours of Work

  • This is a full-time position
  • Some flexibility in hours is allowed, but the employee must be available during the “core” work hours as published in the BioAgilytix Employee Handbook
  • Occasional weekend, holiday, and evening work required
BENEFITS AND OTHER PERKS
Medical Insurance (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account (medical; dependent care), Short Term Disability | Long Term Disability Life Insurance, Paid Time Off (4 weeks per year), Paid Holidays (9 scheduled; 3 floating), 401k with Employer Match Employee Referral Program (up to $10k), Free Coffee, Tea, Fruit, and Snacks, Discounted Vending Machines (25 cents for everything!), Team Wellness Challenges/Events 
COMMITMENT TO EQUAL OPPORTUNITY
BioAgilytix provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, service in the military, or any other group protected by federal, state, or local law.

Other details

  • Pay Type Salary
Location on Google Maps
  • BioAgilytix Boston, 1320 Soldiers Field Road, Boston, Massachusetts, United States of America