Job Summary

Responsible for the management of a team dedicated to scientific development and assay optimization as it pertains to the Virology laboratory. Will provide operational supervision, technical support and professional and scientific expertise, as needed, to ensure operational excellence.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Planning and ensuring on-time delivery of client projects.
• Lead the development, qualification and validation of new assays that meet industry expectations and current regulatory guidelines. As Virology Subject Matter Expert, provide guidance for resolution of technical problems affecting Virology assays.
• Oversees the optimization of existing Virology assays and their life cycle management, which will include monitoring to assess the need for subsequent requalification. 
• Support and manage the technical transfer of in vitro Virology assays. 
• Work with Sales to identify and fill gaps in Virology testing. 
• Partner with Business Development in providing and reviewing pricing and proposals, and provide excellent service to clients.
• Act as a liaison with other departments to ensure that any method development appropriately aligns with Virology processes and subsequent routine testing.  
• Supports other operational areas in relation to virus based work, as needed, by providing guidance for R&D.
• Participate in client technical calls to assist with Virology assay development or trouble shooting.
• Supervise technical staff and perform personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions, time and vacation approval and preparing and delivering annual performance and salary reviews.
• Develop and maintain departmental systems and SOPs. Maintain compliance of operating documents through review and revision as required by SOPs. Assist in the development and communication of departmental policies and procedures.
• Participate in and support cross-functional communication and laboratory activities, as necessary. 
• Assist in the development of the departmental budget, including resource allocations and needs, and authorize expenditures.
• Ensure adherence to pertinent regulatory requirements and to departmental policies.
• Perform all other related duties as assigned.
• With respect to all Virology assays and tests, the manager assures that:
• Study or assay protocols are approved as provided by applicable regulatory requirements and that the protocols are followed.
• All experimental data, including unanticipated observations, are accurately recorded and verified.
• Unforeseen circumstances that may affect the quality and integrity of the study are noted when they occur, and corrective action is taken and documented.
• Test systems, including reagents, live cells, equipment or other materials are as specified in the protocol.
• All applicable good laboratory or manufacturing practice regulations are followed, as applicable.
• All raw data, documentation, protocols, specimens, and final reports are transferred for archiving during or at the close of the study.
   

Job Qualifications

Education: Bachelor’s degree or equivalent in biology or a related discipline. Master’s degree preferred.
Experience: Minimum of 4-5 years related laboratory experience in Virology or related field.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: None.
Other: Demonstrated leadership skills required. Working knowledge of cGMPs or regulatory requirements pertaining to the pharmaceutical and biotechnology industries required.

PHYSICAL DEMANDS:

• May have exposure to potential chemical, electrical, biological and waste-handling hazards.
• Must regularly operate a computer and other office machinery (i.e., calculator, copy machine, and computer printer).
• Regularly moves about to access file cabinets, equipment, and personnel.
• Ability to observe laboratory test results using a microscope to differentiate shapes, colors and other qualitative properties.

WORKING ENVIRONMENT:

• General office and laboratory working conditions.
• Laboratory working conditions may occasionally require wearing personal protective equipment, including but not limited to: goggles, face shield, surgical mask, cap, gloves, scrubs and/or shoe covers.
• Work with or near toxic or caustic chemicals and biological agents including potential biohazards. Possible exposure to fumes or airborne particles.
   

Compensation Data

The pay range for this position is $105,000-$110,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.

Competencies