• Developing and implementing state-of-the-art and fit-for-purpose analytical methods for: release testing, stability testing, product characterization/optimization, reference standard characterization, and investigations 

• Authoring technical reports for investigations, product and impurity characterization, and regulatory submissions 

• Generates, analyzes, and interprets analytical data to support product development, investigations, and regulatory submissions 

• Guides resolution of scientific/technical issues 

• May participate or contribute to critical analytical development teams (e.g., Product and process development teams, Product quality teams) by communicating analytical updates, analytical documentation and data  

• Determines detailed analytical procedures for release, stability, and product characterization testing, including timelines, milestones, methodological approaches, expected results, and necessary resources 

• Works independently and integrates output into overall project deliverables 

• May manage a team of lab associates to accomplish project deliverables 

• Keeps current in analytical development field including literature and technology development for cutting edge and regulatory driven activities and applies this knowledge to the evaluation and development of new methodologies 

• Recognized as a scientific resource in area of expertise 

Basic Qualifications 

• Doctorate degree & 2 years of relevant scientific experience OR 

• Master’s degree & 5 years of scientific experience OR 

• Bachelor’s degree & 7 years of scientific experience 

Preferred Qualifications: 

• Expertise in cell culture and cell biology techniques for quantitative determination of biological activity of proteins 

• Expertise in cell-based bioassay development (method characterization, qualification, validation, technical transfer)  

• Expertise in virology and oncolytic viruses preferable 

• Experience with signal transduction, gene expression, receptor binding and fluorescent probe technologies 

• Experience in molecular biology techniques to manipulate plasmid constructs for generation of transfected stable cell lines 

• Experience with flow cytometry 

• Experience with regulatory filings (IND, BLA, and NDA) and ICH Guidelines 

• Ability to expand analytical development expertise to a broader level of understanding in pharmaceutical R&D and commercialization 

• Resource management – Ensures resources are utilized fully and productively and that adequate resources are projected and selected to accomplish unit responsibilities   

• Innovation – positive approach to challenges; champions new ideas and initiatives; brings out and utilizes others’ creativity to improve unit performance   

• Client orientation– establishes effective and responsive relationships with all clients; translates client requirements into work design; ensure value is delivered   

• Performance management – ensures direct reports are adequately oriented and developed to perform at a high level; monitors performance and provides adequate feedback through coaching and effective performance appraisal and development planning   

• Leadership – establishes and implements strategy using an appropriate leadership style; builds teamwork and collaboration   

• Communication – Excellent written and oral communication skills.  Establishes and maintains effective communication mechanisms to keep staff appropriately informed; bridges communication between individuals, units and other organizations as necessary   

• Interpersonal skills – communicates effectively with others, using appropriate diplomacy and sensitivity; makes others feel respected, valued and understood