Date: 14-May-2013
To see other BioTech job opportunities,
please visit http://biotech.fyicenter.com/
Associate Director, Bioassay Development
• Lead bioassay development and manage a group of scientists
• Develop and qualify robust bioassays for antibody drug conjugates in support of QC release and stability testing, product characterization, process and formulation development
• Interact with research and development groups on a scientific and strategic level
• Interpret and present data to appropriate stakeholders
• Participate in cross-functional project teams to evaluate critical quality attributes of antibody drug conjugates and recommend control strategy
• Author and review sections for regulatory filings, and draft responses to regulatory questions
• Develop neutralizing antibody assays for characterization of human immune response to therapeutic antibody drug conjugates
• Provide guidance in technology advancement and mentor scientific staff
• PhD in life sciences
• minimum 10 years industry experience in biologics development
• Hands-on proficiency with cell-based assays (binding, cytotoxicity, effector functions, etc.)
• Excellent understanding of current industry best practices and regulatory guidance for potency assays
• Knowledgeable in statistics required for potency analysis
• Ability to motivate others and deliver in a timely manner
• Ability to think strategically and adapt to changes quickly
• Strong ability to multi-task in a fast-paced environment
• Demonstrated ability to communicate professionally and diplomatically
• Strong managerial, organizational and interpersonal skills
• Ability to present in a concise and impactful manner
• Experienced and knowledgeable in GMP regulations
• Demonstrated ability to operate independently and in team settings
• Experience in immunological and biological characterization of antibody products a plus
• Regulatory experience in addressing bioassay questions for early and late stage products highly preferred
To apply for this position, please visit
this Website.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
