Vice President, Biomanufacturing Operations

Precision NanoSystems, Inc.

 

Position Summary

The Vice President, Biomanufacturing Operations will be responsible for the operational aspects of
PNI’s rapidly growing genetic nanomedicine contract development business, including introducing,
establishing and expanding capabilities and business offerings to include cGMP manufacturing.
PNI’s hardware platforms, formulations portfolio, world recognized nanomedicine expertise and
clinical manufacturing know-how form the basis of a Biomanufacturing Contract Development and
Manufacturing Organization (CDMO) business to serve the rapidly growing genetic medicine
pipeline.

The qualified individual will be an operational leader with responsibility for the CDMO business P&L
and partner closely with the commercial team to ensure commercial/financial targets are set and
achieved. The Vice President, Biomanufacturing Operations will be responsible to provide leadership,
ensure revenue fulfillment, drive operational readiness, support facility build-out and oversee
operations.

Areas of Responsibility:

  • Manages all operational aspects of a services business including productivity, quality, cost, planning and daily business processes to meet company objectives.
  • Responsible for delivering client projects from early tasked based work, including formulation design consultation and then to tech dev, GMP clinical and small batch production.
  • Manages directly or indirectly the following teams: formulation development, tech dev, process development, quality assurance, analytical/quality control, production and facilities.
  • Leads the business ramp-up, team planning, recruitment, training and development, process validation, cGMP documentation and production planning.
  • Supports development and drives implementation of strategic plans that will grow the business with existing customers and potential new customers.
  • Manages operational enhancements by identifying opportunities for continuous improvement and adoption of emergent relevant methodologies, tools and applications to ensure fit-for-purpose, simplified and effective processes.
  • Ensures compliance with all applicable corporate and regulatory SOP, cGMP, and safety guidelines, in conjunction with the quality team.
  • Develops, achieves, and reports operational performance metrics on weekly, monthly, and ad-hoc basis as required.

Qualifications and Experience

  • Bachelor’s Degree in Life Sciences, Pharmacy, Engineering, Manufacturing, Operations, or equivalent experience.
  • Minimum 10 years of drug product manufacturing experience at a leadership level in the pharmaceutical or related industry. Operational and business/plant start-up experience strongly preferred.
  • Successful P&L experience with knowledge of the levers that drive revenue and margin at the business unit level.
  • Demonstrated leadership skills and track record of success in hiring talent, building strong teams, organizational scaling, and successfully achieving operational and financial results.
  • Brings a blend of strategic and operational expertise and a track record of leadership experience delivering strong operational results in diverse, fast changing environments.
  • Extensive experience managing a dynamic and complex manufacturing business in a highly regulated environment.

Link to Apply
https://pni.bamboohr.com/jobs/view.php?id=107