Aspyrian Therapeutics Inc. is a clinical stage biotechnology company located in San Diego, California, developing novel cutting-edge anticancer therapeutics based on a proprietary technology exclusively licensed from the National Cancer Institute at the NIH (USA). The company is rapidly expanding its pre-clinical R&D activities in support of its clinical pursuits.
Aspyrian Therapeutics is looking for a Director of Analytical Characterization and Quality Control. This position is key member of the Technical Operations team responsible for building and leading a laboratory-based group in analytical development / quality control in a science-driven and collaborative environment in support of the development of Aspyrian’s first-in-class photoactivable monoclonal antibody conjugates. The ideal candidate will have shown proficiency in both hands-on analytical work, the ability to manage activities and solve analytical challenges at third party pharmaceutical manufacturers for complex biologics (specifically antibody drug conjugates). Responsibilities include method development, qualification, validation, structure elucidations, structure / function assessment, stability study support and QC oversight.
Specific areas of responsibility include, but are not limited to, the following:
• Build a strong and state-of-the art analytical characterization group including personnel recruitment, laboratory operations, and equipment procurement
• Develop analytical methods suitable to support analytical characterization that meets anticipated regulatory requirements for Aspyrian’s lead clinical candidate
• Establish and manage an internal Quality Control group
• Work with internal and external laboratories to manage and oversee review of raw data packages associated with method qualification/validation, release testing, specification establishment, stability testing, and other characterization testing of drug substances and drug products.
• Provide analytical support for drug product formulation and process development activities including characterization of the process and finished product.
• Support activities at relevant vendors (manufacturers, testing labs) during the development and characterization of the drug substance / drug product. Travel to external facilities / laboratories as needed.
• Develop and ensure the delivery of high quality documentation to meet global regulatory expectations related to structure / function elucidation and method establishment. Address technical inquiries from regulatory agencies to support clinical trial and commercial marketing applications.
• Apply technical and management expertise to meet project goals and timelines, and to make technical and management decisions to keep projects on track.
Aspyrian Therapeutics is a dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. As a key and senior member of the Technical Operations team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.
• PhD with at least 10 years’ experience in analytical development and analytical characterization with a strong background in characterization of complex biologics such as antibody-drug conjugates.
• Strong background in all analytical methods typical for characterization of complex biologics including HPLC, ELISA, LC-MS, peptide mapping, and methods for secondary and tertiary structure analysis.
• Knowledge of state of the art methods for aggregate and particulate analysis.
• Demonstrated knowledge of cGMPs and relevant regulatory guidelines, both in the US and Europe.
• Experience at all phases of development, including commercialization.
• Experience with preparation of and guidelines for Chemistry, Manufacturing and Controls (Module 3) worldwide regulatory submissions.
• Demonstrate experience of successful hiring and management of an analytical development, analytical characterization, quality control or related organization / group.
• Excellent oral and written communication skills
• Excellent interpersonal and team building skills
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
• Ability to exercise creativity and judgment
• Willing and able to conduct business travel (including overnight stays) by air/rail/auto up to approximately 20%