Senior Manager, MSAT

The Role:

ElevateBio is looking for an outstanding candidate for critical position to serve as a technical program lead in our Manufacturing Science and Technology Organization in support of our growing client portfolio for genomic medicines. This role is responsible for executing end-to-end technical support of GMP manufacturing of autologous/allogenic cell therapies, viral vectors, mRNA, other modalities, and technology platforms. You’ll work to support direct tech transfers from our partners and our Process Development team into the manufacturing environment including bringing programs from demonstration runs through successful engineering runs and aseptic process simulation. Initially, this position will also support the startup of the BaseCamp Pittsburgh manufacturing facility that is currently under construction by providing leadership in the planning and execution of process, equipment, and operational readiness for GMP manufacturing. Candidates should have extensive experience with biologics manufacturing in a GMP setting, technology transfer, CMC strategy, and working within highly matrixed cross-functional teams. This position may lead and/or build a small team of direct report(s).

Here’s What You’ll Do:

• Lead direct tech transfers of autologous/allogenic cell therapies, viral vectors, mRNA, other modalities, and/or technology platforms into the facilities at BaseCamp. Transfers may occur internally at Pittsburgh or externally to other facilities.
• Provide key technical leadership for pre-clinical, clinical, and commercial programs across all aspects of the product lifecycle including technology transfer, process fit, process design, and manufacturing support.
• Manage and trend in-process data for ongoing manufacturing campaigns. Support our partnerships with data access, trending, and analysis.
• Ensure successful delivery of GMP material in partnership with Manufacturing, Supply Chain, Quality and supporting functions by providing technical oversight of manufacturing batch execution, deviation management, troubleshooting, and batch disposition.
• Support transfer of technical expertise and knowledge to the Manufacturing team through training, education, and support
• Assist with the development and drafting of study plans and protocols as required to support regulatory requirements, deviation response, and process changes.
• Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.), as needed.

Requirements:

• Minimum Bachelor’s Degree in Engineering, Science, or related field. Master’s or Ph.D. preferred.
• At least 8 years of experience in a Manufacturing, Technical Operations, or GMP environment supporting complex products. Experience in autologous gene or cell therapy a plus.
• Extensive experience in leading product/process support within a GMP setting leading investigations, technology transfer, process monitoring, process validation, and routine clinical/commercial support.
• Experience working within a contract manufacturing or client service organization preferred.
• Demonstrated ability and strength in leading cross-functional teams within a matrixed organization. Experience managing direct reports a plus.