Scientist/Study Director, Virology

WuXi AppTec Philadelphia, PA
Overview

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. Works independently in improvement of existing assays. Strong technical understanding of virology and cell culture processes. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Strong understanding of virology and cell culture processes. 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 as required.

Responsibilities

* 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

* Effectively 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.

* Interacts with pertinent internal departments (i.e. Quality Assurance and Project Management) 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 that batch records and other paperwork are completed according to GLPs / cGMPs and company SOPs.

* Reviews Final Reports for protocols assigned Study Director and participates in critical review and interpretation of test results.

Qualifications

* Master's Degree with a major in Biological Science or other science related major required. PhD strongly preferred!

* 5+ years of laboratory experience in Virology required

* Must have strong skills in cell culture

* Expert in Antibody / Protein Purification- including Chromatography and filtration experience

* Technology and Downstream Scale up / Scale Down

* Possesses thorough knowledge of analytical and protein-based assay(s)

* Knowledge of GLP and cGMP preferred

* 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

Equal Opportunity Employer Minorities/Women/Veterans/Disabled