Head of Biologics Development and Technology
This individual has accountability to oversee and deliver all technical activities for the end-to-end development lifecycle of recombinant drug substance in support of biosimilar programs. The scope of the programs includes affordable insulin, as well as future biosimilars. The successful candidate will work through development partners and CDMO’s to ensure all aspects of the drug substance process development and manufacturing, from host selection through final Drug Substance, are completed according to cGMP and Quality by Design principles. For new products, this individual will partner with Business development, Quality, and Executive Leadership to identify and secure agreements with potential CDMO’s and explore existing technology platforms related to biosimilars. This leader will have full lifecycle accountability from initial development through post-approval changes.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Accountable as technical subject matter expert for all drug substance process development and manufacturing information supportive of the Biologics Licensing Application (BLA).
- Provide input to selection of drug substance Contract Development and Manufacturing Organizations (CDMO) to company Executive team.
- Manage and oversee the delivery of process development and characterization activities to ensure a robust, efficient process is developed and approved by US FDA.
- Act as accountable person for all drug substance related sections of the CMC dossier for IND and BLA filings with health authorities
- Ensure robustness and quality of drug substance.
- Work with DP development team to ensure drug substance input material meets requirements.
- Will act as individual contributor working through CDMO’s at first but may build/manage a small team of scientists/engineers to enable program delivery.
- Work with CDMO project management and program management to build tech transfer and startup schedules, and carefully manage schedule adherence.
- For startup sites, work directly with general management and staff to recommend and implement operational improvements.
MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)
- Minimum 10 years’ experience, with experience in supporting BLA-enabling process development.
- Experience with Drug Substance development IND and BLA support, with biosimilar experience a plus.
- Experience in Quality and Operations organizations within GMP manufacturing
- MS preferred, PhD a plus, BS/BA level collegiate degree required in bioprocess engineering, chemical engineering, biology, microbiology, or other related fields to biologics manufacturing.
- Requires up to 35% travel to partner CDMO’s, including international travel to India. Time outside of travel can be conducted as remote-by-design.