Director, Downstream Process 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 Director of Downstream Process Development, who will lead the Downstream Process Development function for the Biologics, Vaccines, and Gene Therapy modalities.  This leader will play a critical role in revolutionizing the way drugs are developed and manufactured at Resilience. Reporting to the Head of Process and Downstream Process Development – Biologics, Vaccines, and Gene Therapy, the Director of Downstream Process Development will be accountable for the flawless execution of the Biologics, Vaccines, and Gene Therapy downstream process development activities; spanning technical development, process transfer, manufacturing, product release and successful preparation of regulatory submissions.  She/he will oversee and drive a team of downstream process scientists that manage the downstream process development-related activities, for multiple projects. 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 recovery and purification operations; spanning the needs of the Biologics, Vaccines, and Gene Therapy modality.
 

The ideal candidate will work with the Head of Process Development - Boston, customers, and internal scientific leaders to design and implement technical strategies which deliver the latest scientific and Downstream Process 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 process capabilities that are clearly tied to business, client, and scientific requirements
• Lead a team of technical staff and provide day-to-day support, career development and mentorship 
• Coordinate the alignment of the overall Downstream Process function, with other site PD leaders, to define work processes that maximize efficiency, predictability, and velocity
• Provide technical, tactical, and scientific leadership to the team in the development, qualification, and implementation of innovative, robust, cost-efficient downstream process capabilities that are clearly tied to business, client, and scientific requirements
• Provide input into the advancement of downstream process methods such as high-throughput screening, implementation of PAT technologies, and continuous/connected-DSP processing and their applications to the characterization of Biologics, Vaccines, and Gene Therapy products
• Direct a seamless interface with operational teams to transfer in process capabilities and to address any problems or unexpected results in manufacturing
• Interface with candidate clients to highlight company capabilities and approaches; author and provide critical technical feedback on client project proposals
• Provide representation to CMC teams for collaborative client projects for strong communication, strategy setting, and execution
• Collaborate with process and analytical development teams to ensure appropriate experimental design, sample analysis, and data interpretation
• Lead 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,