Operations Manager

Job Description

Job Description

BioIVT is a leading global provider of research models and value-added research services for drug discovery and development. We specialize in control and disease-state biospecimens, including human and animal tissues, cell products, blood and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research, aiming to improve patient outcomes by coupling comprehensive clinical data with donor samples. As the premier supplier of hepatic products, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and their effects on disease processes. By combining our technical expertise, exceptional customer service and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in elevating science.

SUMMARY

This role will plan, coordinate and execute production activities as instructed by the Site Lead. Additionally, this role will be responsible for the overall coordination, and evaluation of the operation, ensuring a safe and productive workplace.

This position will ensure compliance with Environmental Health and Safety (EHS) policies, State Departments of Health, Good Documentation Practices (GDP), Good Laboratory Practice (GLP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), EMEA and FDA Guidelines, general State and Country Regulations such as but not limited to (CLIA, CAP, USP, ISO 9001, USDA regulations, HTA license, DEA and State Controlled Substance programs) where site appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Manage employees in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning, and directing work; supporting managers/directors in performance appraisals; reviewing weekly timesheets and time-off requests; providing regular feedback, and setting individual goals aligned with team and department goals.
• Ensures site quality compliance of Standard Operating Procedures (SOPs), State and Federal regulations, OSHA, CLIA, and cGMPs standards to ensure facility compliance.
  1. Review site Quality Control and take part in Quality Assurance initiatives.
  2. Implement effective corrective action plans as appropriate for non-compliance, customer complaints, and departmental deviations.
• Drive the achievement of company objectives regarding cost, productivity, customer service, profits and team members.
• Schedule, Control, and Assign production tasks to the appropriate staff to ensure efficiency of manufacturing quality products for all products manufactured.
• Participate in daily planning and staff meetings.
• Ensure daily shipments are complete and ready to ship on time.
• Manage supply inventory to the optimum levels by maximizing efficiencies, customer service levels and minimizing investment.
• Responsible for the management of maintenance and/or routine service and calibration of scientific and technical instrumentation and equipment.
• Oversee and ensure a clean and functioning facility through established cleaning and maintenance programs.
• Assist in the development and validation of new laboratory procedures and techniques.
• Analyze, summarize, and verify routine data analyses and data summary.
• Manage customer and regulatory audits.
• Manage and contribute to control systems to ensure that operational performance goals are met.
• Perform other duties, as necessary.

TRAVEL

This position may require up to 1 % travel over the course of a year.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Education and/or Experience

• Bachelor’s degree (B.S./B.A.) from four-year college or university; or high school graduate with three years of related experience and/or training; or equivalent combination of education and experience. Bachelor’s degree in a biological or chemical science field preferred.
• Ability to effectively present information in small group situations to management, customers and other employees of the organization.  

Certificates, Licenses, Registrations Required

• None required.

Other Skills and Abilities

• Proficiency in a variety of computer software programs including MS Office
• Ability to work in a team laboratory environment with knowledge or familiarity with scientific terminology.

PHYSICAL DEMANDS

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 may be required to: stand for 6+ hours/day; walk, sit, stoop, kneel, crouch, crawl, speak, hear/listen, smell, display manual dexterity, reach with hand and arms. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds

WORK ENVIRONMENT

The employee must have the ability to work in a cold storage warehouse with temperatures between -20 and 34 degrees C as needed. Availability to work occasional to frequent overtime.

Administrative – While performing the duties of this job, the employee will be working in a professional office environment using standard office equipment.

Lab / Lab Support - While performing the duties of this job, it is frequently required to use personal protective equipment to prevent exposure to hazardous materials. The employee has potential for exposure to fumes, airborne particles and toxic or caustic chemicals, biohazards, flammable liquids, and risk of radiation. The employee is occasionally required to use equipment with moving mechanical parts, with risk of electrical shock and vibration. The noise level in the work environment is usually moderate, at times, the noise level can be louder and hearing protection may be required. The employee may work both inside and outside in heat/cold, wet/humid, and dry/arid conditions.

The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently. Employees will be required to follow any other job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws. All job requirements are subject to modification to reasonably accommodate individuals with disabilities. Continued employment remains on an at-will basis, unless otherwise contractually bound.

We offer a comprehensive benefit package for eligible team members, including medical, dental, vision, short-term/long-term disability, life insurance, hospital indemnity and accident insurance. We also provide a generous retirement plan with a company match. Eligible employees enjoy competitive time-off policies and a collaborative environment that promotes growth from within. Enjoy company-sponsored events for the entire team!

Join Us!

We can’t wait to work with you! At BioIVT, we believe that diversity and inclusion are key drivers of innovation and success. We are committed to creating a workplace where everyone feels valued, respected and empowered to bring their unique perspectives to the table. We seek to build a diverse team and encourage applications from people of all backgrounds, experiences and identities.

To Learn more about our mission and team culture, click here!

BioIVT is an equal opportunity employer. We celebrate diversity and are dedicated to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.