Bioassay Virologist (Sme) - Pharmaceutical Site Start-Up

Job Description
POSITION SUMMARY:
We have an exciting opportunity for an SME in Bioassay/Virology to help our client set-up a new laboratory. The Principal Scientist, Bioassay/Virology is responsible for contributing to key functional, tactical, and operational aspects of the QC group at our PSS client site.
This position will work with global clients and is accountable for GMP compliant laboratory operations according to regulatory guidelines in setting up a new laboratory. This role is responsible for implementing processes for ELISAs, Potency assays, residual DNA/Host Cell Protein/Protein A assays, qPCR assays and Adventitious Virus testing.
The Principal Scientist, Bioassay/Virology is the technical subject matter expert (SME) with in‐depth knowledge of QC analytical methods including:
ELISAs, potency assays, qPCR assays, residual DNA/Host Cell Protein/Protein A assay, Adventitious Virus testing and will support troubleshooting of complex investigations and optimizing laboratory systems, ensure that the laboratory is set-up and operating in a state of GMP compliance, all documentation is in accordance with GMP, and that all reported results are accurate.
POSITION RESPONSIBILITIES:
Advanced knowledge and experience working with BSL1 and BSL2 viruses in a GMP lab environment including mammalian cell culture propagation and maintenance.
Advanced knowledge of QC testing involving:
ELISAs, Potency assays, residual DNA/Host Cell Protein/Protein A assays, qPCR assays and Adventitious Virus testing
Knowledge and experience growing, purifying, and quantitating live viral stocks for use in infectivity assays.
Excellent technical writing, presentation and communication skills
Advanced Knowledge of cGMPs, ICH, USP, EP, JP and FDA requirements as it relates to Bioassay/Virology analytical methods.
Demonstrated complex problem‐solving skills, support team in driving to resolution of complex problems and reach out externally to regulatory/global teams/sites for alignment ‘
Must be able to assist in setting and reporting measurable goals &
targets and mitigation plans as appropriate
Demonstrated leadership abilities, strong presentation, oral and written communication skills;
ability to communicate with management, peers and subordinates effectively, strong organizational skills;
ability to multi‐task and coordinate multiple activities in parallel, demonstrated problem solving skills, demonstrated instrument/method troubleshooting skills, understanding of relevant FDA/EMA regulations and compliance.
Broad knowledge of operations/quality systems/directives, accountability for self and immediate work team through delivery of appointed deliverables
Authors technically‐sound simple to moderately complex reports with limited guidance
Leadership competencies include Follow up, Decision Making, Communication, Collaboration and Innovation in support of our PSS client
Able to work effectively, independently and within a team framework, across all business areas and levels of the client organization.