Full-Time
Senior Director
Msat, Basecamp Waltham
Confirmed live in the last 24 hours
Offers cell and gene therapy technology platforms
Industrial & Manufacturing
Senior
Waltham, MA, USA
Requirements
- Minimum Bachelor’s Degree in Engineering, Science, or related field. Master’s or Ph.D strongly preferred
- At least 15 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 is 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 strongly preferred.
- Demonstrated ability and strength in leading cross-functional teams within a matrixed organization.
Responsibilities
- Manage and expand the Manufacturing Sciences and Technology (formerly Technical Operations) organization for BaseCamp Waltham.
- 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.
- Create and launch process monitoring/trending, process validation, and process performance qualification programs (PPQ). Support client and/or internal product PPQ activities and management for on market products.
- 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 study plans and protocols as required to support regulatory requirements, deviations response, and process changes.
- Partner with CMC Regulatory and SMEs to develop content for regulatory submissions (INDs, BLAs, DMFs etc.)
- Actively support internal and regulatory audits of BaseCamp Waltham.
- Provide technical leadership for the design, construction, commissioning, qualification, validation, and operation of manufacturing expansion initiatives at ElevateBio.
ElevateBio specializes in cell and gene therapies, offering integrated platforms for gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering. Their purpose-built manufacturing platform, BaseCamp, provides process innovation and cGMP manufacturing capabilities for viral vectors, RNA, and cell therapy production.
Company Stage
Series D
Total Funding
$1.2B
Headquarters
Waltham, Massachusetts
Founded
2017
Growth & Insights
Headcount