About this role
Role Overview
- Leads the manufacturing team through facility start-up, setting the operating standards for a brand-new biologics plant
- Directs manufacturing of recombinant proteins according to approved protocols, regulations, and schedules across 2,000L and 10,000L bioreactor suites
- Translates corporate objectives into strategy, connecting floor-level performance to global IOPS goals
- Guides validation activities and equipment commissioning/qualification to ensure operational readiness
- Partners across Facilities, Process Development, Quality, and Regulatory to keep production running smoothly
- Builds and develops a high-performing team, embracing the ambiguity that comes with standing up a new site
- Tracks and trends key metrics to keep operations safe, compliant, and efficient
- Thrives on ownership, taking accountability for team performance and results from day one
Requirements
- Bachelor's in a physical or biological science or chemical engineering
- 12+ years of biopharmaceutical/biotech work in a GMP production facility
- 8-10 years (MA/MS), or 4-7 years (PhD) of biopharmaceutical/biotech work in a GMP production facility
- Demonstrated experience leading operational start-up for a clinical and commercial biologics manufacturing facility
- Experience working with industrial systems such as SCADA, DCS, MES, and PAT technologies
- Familiarity with other Industry 4.0 technologies and strategies is a plus
- Regular presence on the production floor and entry into classified/controlled environments requiring gowning
Benefits
- annual bonuses or other incentive plans
- equity awards
- pension or retirement benefits
- 401(k) company match
- health and wellness programs
- fitness centers
- insurance benefits (e.g. medical, dental, vision, life and disability)
- paid time off
- family support benefits