Senior Director, Analytical Development

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

Resilience is seeking a highly experienced and scientifically-driven Senior Director of Analytical Development, who will lead the Analytical Development functions across the Biologics, Vaccines, Gene Therapy and Nucleic Acid technology areas.  This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the VP & Head of Technical Development, the Senior Director of Analytical Development will be accountable for the flawless execution of our Analytical Development activities; spanning technical development, method transfer, manufacturing, product release and successful preparation of regulatory submissions.  She/he will oversee and drive the teams of analytical scientists that manage the Analytical Development-related activities, for multiple projects. The Senior Director of Analytical Development scope will span programs across the Biologics, Vaccines, Gene Therapy, Cell Therapy or Nucleic Acid franchises. This leader will be responsible for driving a deeply scientific and customer enabling culture.  A key aspect of the role will be the technical mentorship of the staff and the ability to raise their technical expertise through close interaction and mentorship.  The successful candidate must have hands-on background in development and GMP implementation of molecular, physical-chemical, and bioassay analytics; spanning the needs of Biologics, Vaccines, Gene Therapy (AAV & LVV), and Nucleic Acid modalities.  Knowledge of Cell Therapy analytics is a plus. 
 

The ideal candidate will work with the modality Technical Development Heads, customers, and internal scientific leaders to design and implement technical strategies which deliver the latest scientific and analytical innovations to our technical development and manufacturing infrastructure, network and client partners. We are seeking an experienced drug development leader to play a key role in coordinating and delivering successful customer and internal programs.  This individual will be a team leader that motivates employees to execute our mission and nurtures the development of scientific talent into world class drug development teams.

Job Responsibilities

• Be accountable for the flawless execution of customer projects from technical development, through manufacturing operations and culminating in the successful preparation of regulatory submissions
• Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient analytical capabilities that are clearly tied to business, client, and scientific requirements
• Lead a team of technical and operational group leaders and provide day-to-day support, career development and mentorship 
• Coordinate the alignment of the overall analytical function, with other site AD leaders, to define work processes that maximize efficiency, predictability, and velocity
• Provide technical and strategic guidance in the development of a toolbox of functional assays that can progress to implementation as potency assays, with phase-specific qualification
• Direct a seamless interface with operational teams to transfer analytical capabilities and to address any problems or unexpected results in manufacturing and QC
• Interface with candidate clients to highlight company capabilities and approaches; author and provide critical technical feedback on client project proposals
• Collaborate with process development teams to ensure appropriate experimental design, sample analysis, and data interpretation
• Develop and drive the gathering and analysis of data trends, including assay controls and batch-specific data
• Direct authoring and review of technical and scientific documents, including (but not limited to): study protocols and reports, validation documents, SOPs, regulatory submissions, and test methods
• Serve as a technical beacon for the team by maintaining expertise, reviewing publications, attending conferences and networking across other Resilience sites to support an analytical development community of practice
• Foster a culture of innovation and an environment of technical mastery at all levels
• Manage resource allocation and set priorities and objectives for the team to ensure timely compl