Job ID 2019-5843
Manages the day-to-day virology operations (employees, resources, programs and capacity) to ensure execution of testing. Oversees the performance of the team to direct or perform assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Holds the team accountable to operational and performance metrics. Strong technical understanding of virology and cell culture processes. Acts as Study Director/Technical Reviewer as required.
- Manages, plans and reviews operations for assigned staff, including testing, scheduling, capacity and maintaining standards.
- Develops and Manages to Operational and Performance Metrics
- Recommends hire / transfer / promotion / discharge and salary changes and acts on employee problems.
- Conducts employee performance appraisals in a timely and objective manner.
- Provides strong in-house guidance on science and technology.
- Interacts with clients to discuss project planning and testing issues.
- Interacts with internal staff to identify assays requiring further improvement or development and oversees improvement of these assays.
- Responsible for team members that appropriately conducting assays in accordance with GLPs or cGMPs.
- Assures that laboratory personnel are following all company SOPs and safety rules.
- Prepares and revises technical documents (Client Protocols, SOPs, etc.)
- Assures that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs.
- Effectively communicates and defends science through written and verbal communication
- Provides operational support for Virology activities including (Ex. media/buffer preparation, cleaning activities, and equipment/materials staging/ Aseptic Technique).
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- Normally receives minimal instructions on routine work and detailed instructions on new assignments.
- Ability to work in a team environment and independently as required
- Accomplishes staff results by communicating updated organizational information,
job expectations & supporting their work
- Plans, monitors, and appraises direct reports including performance
competencies, goals & job results
- Coaches, counsels, and conducts disciplinary actions
- Develops, coordinates, and follows organizational systems, policies, procedures,
and follows labor and capacity standards
- Contributes to the overall operations and to the achievement of departmental
- Perform job specific tasks in compliance with applicable Regulations,
- International Standards, and WuXi AppTec Policies and Standard Operating
- Thorough understanding of Good Laboratory Practices and Good Manufacturing
- Other duties as assigned
- May be required to assist in other departments
Experience / Education
- HS Diploma or equivalent required and
- 5+ years relevant technical experience and min 2 years Managing people
- BS/BA in Science related field preferred; or combination of relevant Experience &
Knowledge / Skills / Abilities
- Experience in Virology, cell culture, and lab management (preferably high
volume in a GMP environment)
- GLP and cGMP experience
- Effective multi-tasking skills and time management required
- Ability to evaluate technical data and record data accurately and legibly
- Ability to accurately and reproducibly perform complex mathematical and
- Ability to use judgment as dictated by complexity of situations
- Ability to understand and follow verbal and demonstrated instructions
- Ability to clearly express and exchange ideas by means of verbal and written
- Ability to work effectively as part of a team and exhibit effective interpersonal
- Ability to work under limited supervision and to handle problems of a difficult
- Ability to perform light physical work, lifting up to 20 pounds as needed, and
performing activities such as repetitive motions
- Clarity of vision at all ranges, depth perception, and ability to identify and
- Proficient in Oral & Written communication skills
- Need to be able to read, write and understand English
- Proficient in Microsoft (Excel, Word, Outlook)
- Travel may be required
- Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting with Biohazards /various Chemicals
- Must be able to wear appropriate PPE
- Must be able to work in environment with variable noise levels
- Ability to stand /Sit/walk for long periods of time
- Ability to Lift 20 lbs routinely
- Ability to crouch, bend, twist, and reach
- Clarity of Vision
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.