Location: Cincinnati,OH, USA
About Meridian
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary
Responsible for planning, coordinating, scheduling, and managing technical production activities associated with the manufacture of proficiency specimens and control materials. Ensures that production activities are timely and completed in accordance with established quality standards and procedures. Ensures that product demand is satisfied in a timely manner. Ability to troubleshoot and investigate production problems. Assist in developing and implementing policies and procedures that ensure effective completion of area functions. Coordinates closely with related departments to maintain schedules and effect necessary changes and revisions. Assigns, trains, directs, and appraises personnel. Completes related documentation and records as required.
Key Duties
Tasks/Duties/Responsibilities:
* Responsible for managing personnel including training, coaching, scheduling, and preparing and giving performance evaluations.
* Ensure an adequate supply of commodities are available to meet production needs (coordinate inventory management with Materials Management).
* Works closely with upper management to ensure financial goals and production targets are met.
* Assure the proper use, cleaning, sanitization, maintenance, validation, calibration and certification of required equipment as appropriate.
* Author, plan, and/or conduct CAPAs, investigations, and validations as needed, and assure projects meet agreed upon timelines.
* Author and submit OOS's, Deviations, and ECO's as needed.
* Manage interdepartmental improvement or other complex projects from a timeline and cost perspective, while coordinating required activities with appropriate personnel to ensure completion. Develop action item lists, project status reports, and other documents in conjunction with lab personnel and other departments.
* Identifying and resolving production problems in a timely manner.
* Assumes responsibility for assisting in the development and implementation of effective production planning, policies, and procedures.
* Assists Senior Management in developing short-and-long term goals and objectives. Provides suggestions and recommendations.
* Participates in development of policies and procedures and ensure that they support and complement Company-wide strategic objectives.
* Conducts periodic reviews of existing policies and procedures to ensure effectiveness. Ensures that policies and procedures are updated in accordance with evolving production and quality standards.
* Assumes responsibility for the efficient, timely, and accurate completion of production related functions.
* Oversees, manages, and has direct hands-on involvement in the laboratory aspects and related production functions.
* Coordinates with planning and related departments to determine production schedules and to ensure that product is available and meets customer needs.Tests and evaluates products produced to ensure conformity to quality and production standards.
* Investigates and troubleshoots problems and product inconsistencies.
* Establishes and monitors shop floor production schedules and regulates work flow to ensure maximum production capacity.
* Prepares documentation and completes related statistical reports and records.
* Supervises the ordering, allocation, and distribution of production materials.
* Ensures that inventory transactions are correctly entered into computer systems.
* Ensures that production functions are completed in accordance with established GMP, production, safety, and quality standards.
* Conducts and supervises research, and development experimentation associated with product improvement.
* Writes and revises protocols and conducts validation studies.
* Effectively works as a team member with assigned personnel, ensuring optimal performance.
* Provides leadership through effective goal setting, delegation, hands-on involvement, and communication.
* Is an active team member through hands-on involvement in production related activities.
* Trains, advises, and counsels other employees in methods to improve performance and productivity.
* Conducts performance appraisal and directs corrective actions as required.
* Assumes responsibility for maintaining effective communication, coordination, and working relations with other personnel and management.
* Works closely with Purchasing, Kit Assembly, and Quality Control Departments to maintain schedules and meet deadlines.
* Provides assistance and support to related departments as required.
* Keeps management informed of area activities and significant concerns.
* Performs hands-on laboratory and production related duties as needed.
* Completes special projects as assigned.
* Ensures work areas and equipment are clean, safe, and well maintained.
* Is informed and current with respect to new developments and changes in test and production methods
* Other duties as assigned.
Physical Requirements:
* Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
* Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, etc.)
* Willing to work with hazardous chemicals and biological with proper protective equipment.
* Must be a non-smoker in order to perform work within a molecular or cleanroom environment.
* Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
* Must be able to differentiate color differences in device components.
* Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the workday.
* Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the workday.
* Must be able to analyze, concentrate and solve complex issues routinely through the course of the work shift and remain focused in a fast-paced open environment throughout the course of the workday.
* Will carry cell phone to facilitate intra-department communications both during and after normal business hours
Qualifications
Minimum Education or Equivalent Experience Required/Preferred:
* Requires a Bachelor's degree and 5 years of laboratory experience required, FDA regulated laboratory experience preferred. Course work in microbiology, chemistry, molecular biology desired.
* Requires production planning and product troubleshooting experience.
* Requires 5+ years of management experience with proven ability to lead and direct others.
* Experience in scientific/manufacturing principles associated with product design, development, and manufacture in GLP and GMP environments.
Competencies Required or preferred:
* Knowledge of production functions, procedures, and standards. Understanding of virology, immunology, cell and tissue culture, bacteriology, parasitology, and clinical laboratory procedures. Knowledge of clinical laboratory products, techniques, and test methods.
* Aseptic technique, general laboratory techniques.
* Demonstrated strong leadership, team building and organizational skills.
* Strong attention to detail.
* Ability to analyze processes for compliance, determine and communicate vulnerabilities.
* Strong problem-solving abilities.
* Good research and development capabilities.
* Ability to operate specialized laboratory equipment.
* Ability to read, understand and follow all company SOPs and guidelines and ensures compliance in direct reports.
* Must possess exceptional communication, interpersonal, problem solving and customer service skills and ability to interact with all levels within the company and/or vendors. Must be able to explain problems and develop solutions with operational employees.
* Ability to maintain regular attendance and punctuality requirements.
* May be required to work additional hours outside of the normal work shift to ensure departmental goals are met (evenings and weekends).
* Computer proficiency (Word, Excel)
* Be a self-starter, detail oriented, organized and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast- paced environment.
* Highly motivated, readily adapts to changing priorities, effectively manages own time, sets priorities for direct reports to ensure tasks, multiple projects are prioritized and completed on time.
Required Travel %:
* None Anticipated
* We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*