Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the Virology lab. Oversees the transfer of custom studies from the Technical Team to Operations. Leads training on custom methods and mentors operational staff. Utilizes technical expertise in virology and cell culture processes to improve upon existing assays/methods. Possesses strong oral and written communication skills and actively contributes to report generation and documentation. Performs and directs 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). Acts as Study Director/technical reviewer as required.
- Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures
- Transfers and coordinates custom assay projects from development into routine operations
- Interacts with clients to address scientific and project-related issues
- Effectively communicates and defends science through written and verbal communication
- Provides training on areas of technical expertise and compliance issues relevant to the lab setting
- Conducts critical review of results and reports data to appropriate internal staff
- Coordinates with internal departments (i.e. Quality Assurance, Client Services, etc.) to assure that appropriate testing information is effectively communicated and documented
- Prepares and revises technical documents (Laboratory Protocols, SOPs, etc.)
- As assigned by Management, acts as Study Director or Principal Investigator for assigned assays and assumes all associated responsibilities
- Conducts and directs assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
- Assures batch records and other paperwork is completed according to GLPs / cGMPs and company SOPs
- Reviews/writes Final Reports for protocols assigned and participates in critical review and interpretation of test results
- 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.
- Works under close supervision from supervisor or senior personnel.
- Ability to work in a team environment and independently as required
- Maybe required to work Holidays and weekends
- Contributes to the overall operations and to the achievement of departmental goals
- Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
- Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
- Other duties as assigned
- May be required to assist in other departments
Experience / Education
- PhD with minimum 2-4 years of experience or MS with minimum of 4-6 years of experience or BS with 6-8 years of relevant laboratory experience in pharmaceutical or biotechnology industry
- Comprehensive virus, cell culture, ELISA and RT qPCR experience
- Experience with Lenti, Adenovirus and AAV viral vectors
- Client Facing, project management, CRO and CMO experience preferred
- Experience in the Gene Therapy field preferred
- Experience with assay qualification and assay validation a plus
Knowledge / Skills / Abilities:
- Possesses thorough knowledge of analytical and protein-based assays
- Knowledge of GLP and cGMP preferred
- Ability to record data following Good Documentation Practices
- 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 statistical calculations
- Ability to use judgment as dictated by complexity of situations
- Ability to understand and follow verbal and demonstrated instructions
- Ability to trouble shoot and solve technical problems
- 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.