Director, Biologics Analytical

Required

• Accountable for compliance with Environmental Health and Safety regulations for the group.
• PhD with at least 10 years of relevant pharma/biotech industry experience or master’s degree with at least 15 years of pharma/biotech experience.
• Proven experience leading a CMC development organization, such as analytical development, drug substance, parenteral and/or combination products with a range of experience levels and scientific disciplines.
• Skilled in analytical method development, validation, transfer and troubleshooting for biologics. Familiar with extended characterization to evaluate critical quality attributes (CQAs), assess process changes, and prove biosimilarity.
• In depth knowledge in relevant regulations, interactions with regulatory agencies, and deep NDA and BLA experience with major responsibilities.
• Extensive experience and solid understanding of the various scientific disciplines, including analytical control strategies, formulation development, regulatory filings, manufacturing, Quality Assurance (QA), and supply chain.
• Demonstrated record of success leading strategic initiatives and new technology evaluation/implementation.
• Track record on people management experience and leading matrix teams.
• Strong oral and written communication skills.
• Experience in motivating and maintaining positive morale of highly skilled technical individuals and teams in an environment where compliance with standard procedures is required.
• Strong negotiating, influencing, and leadership skills.
• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.