Downstream MSAT Lead

Downstream Manufacturing Support and Technology Lead

Summary

The downstream Manufacturing Support and Technology candidate lead the tech transfer, and GMP execution of production processes for innovative vaccine products. This position will be involved in non-affinity based downstream bioprocess development and GMP production, including lab scale process development, scale up and tech transfer of the process into the GMP suite, and execution of the process under GMP compliant conditions. Purification MS&T will work cross functionally with Process Development, Analytical Development, Program Management, Manufacturing, Quality Assurance and Regulatory Affairs to define and implement manufacturing strategies vaccine products. The candidate will be responsible for both internal and external manufacturing activities. This role will also be accountable for technology transfer, process optimization, facility fitness adjustments, and routine technical support to internal and external manufacturing. The MS&T role will also be working with Process and Analytical Development advance technology to implement robust phase I manufacturing processes. The successful candidate will also provide leadership in defining phase-appropriate process control strategies and development of plans to support readiness. The MS&T candidate will provide technical to support regulatory submissions.

Qualifications

Preferred Ph.D. in Chemical Engineering or Science discipline or M.S. in Chemical Engineering Science discipline plus 10+ years of industry experience including hands on relevant experience including non-affinity biologics downstream process development. A subject matter expert, recognized across the field as a thought leader who envisions new concepts, processes or methods. Lead downstream aspects of lab scale process development and hands on GMP production expertise.

Required Skills

Experience in the biopharmaceutical industry in complex biological product and process development from early stage development, expertise in downstream process and technology transfer of complex biologic products. Experience in supporting regulatory submissions (INDs, briefing packages, BLAs), in good documentation practices, data archiving, and statistical approaches to support data trending and stability analyses, experience in working in a cross-functional matrix model, good planning, organization, prioritization, and management skills to direct the work of others on assigned projects, including internal teams and external collaborators. Demonstrated ability to create and foster effective teamwork, build relationships, motivate others, work in a matrix organization, and collaborate at all organizational levels, results oriented, with a sense of urgency and initiative, accountability, and willingness to take ownership, Comfortable with rolling up the sleeves and executing the work needed to support the success of projects. Strong critical thinking and problem-solving skills Excellent communication skills, both verbal and written, and the ability to interface effectively with all levels of the organization. Strong communication skills with outside contract organizations. Experience complex biologic product development and manufacturing. Excellent working knowledge of GMP and GLP requirements for manufacture of aseptic/sterile biologic products. Downstream techniques with expertise in non-affinity chromatography development, high-throughput resin screening (IEX, HIC, Mix-Mode, Affinity, SEC), optimization, and robustness testing. Filtration Development including development of various filtration techniques including ultrafiltration/diafiltration, depth filtration, viral filtration and sterile filtration. Expertise in viral inactivation methods to suit purification of novel complex biologics. GMP Production, process scale up, tech transfer, and hands on execution of the process under GMP conditions. Must work independently to develop specific processes or methods in line with strategic program goals. Demonstrated advanced ability in solving complex analytical problems in alignment with strategic project plans. Advises management on strategic direction, focus of technical programs and platform process implementation. Identifies and develops collaborations with external organizations and other development teams to provide support for development activities and will work diligently with cell line development, analytical development, upstream process development functions to understand how the cell lines and process impacts product quality. Demonstrated strength in advanced analytical methods, impurity removal including HCP and HCD while maintaining overall yield to enable clinical trials. Facilitates team data review and discussion at group meetings, larger team settings including external collaborators and funding agencies. Provides insight as an external reviewer, and provides perspective to de-risk programs. Leads review of technical development reports, writes and reviews protocols for tech transfer and SOPs for GMP production, and presents data to project teams and larger collaborative settings.