Director Of Operations

Director, Manufacturing Operations - Active Pharmaceutical Ingredients (API)

The Manufacturing Operations Director is responsible for maufacturing operations of the GMP Oligonucleotide Active Pharmaceutical Ingredients (API) CMO business in Boulder, Colorado. This position reports to the General Manager and manages other managers responsible for Manufacturing, Manufacturing Engineering, Operations Planning, and Supply Chain.

Responsibilities:

* Provide strategy and leadership for all aspects of the Oligonucleotide manufacturing operations of Nucleic Acids Synthesis Division, including management of manufacturing, engineering, supply chain and warehouse operations and implementation of effective raw material procurement and inventory management processes.

* Manage the planning and transfer of Oligonucleotide manufacturing process from Process Development Department and third party manufacturers to GMP Manufacturing Facility

* Drive operational excellence and continuous improvement programs and ensure the division s manufacturing efforts are conducted in compliance with cGMP regulation. Collaborate with the division s quality organization to ensure on-going readiness for PAI and other regulatory inspections, continuous improvement of quality systems, timely close out deviations or change controls, and implementation of corrective actions

* Coordinate with customers and internal departments in support of clinical trial and future market supply manufacturing

* Build the department s organizational capabilities and employee engagement; set objectives, provide timely performance feedback and proactive professional development of employees

* Prepare and meet annual and multi-year financial budgets and forecasts

* Interact with senior management, customers, U.S. FDA and other government agencies to accomplish short and long term business requirements

Qualifications:

*B.S./ M.S./ PhD in engineering or science. MBA or equivalent business experience

* 10+ years of Active Pharmaceutical Ingredients (API) manufacturing and or engineering experience under GMP guidelines, including 8-10 years of direct experience managing manufacturing and supporting staffs

* Strong knowledge and understanding of biomolecule manufacturing operations, equipment and facility validation, quality control and quality assurance, process development and manufacturing process design

* Demonstrated effective skills and competencies in leadership, people development and teambuilding. Past tract record of an ability to recruit and retain a motivated and effective team

* Ability to effectively work with the Quality organization, Process Development, Regulatory, Validation, Project Management, and other departments inside the company

* Experience and skill in interacting with FDA inspectors and other government agencies

* Excellent communication, analytical, investigational, organizational and coaching/mentoring skills

* Ability to drive through continuous improvement processes and initiatives

* Ability to work under tight deadlines in a fast moving environment
To find out more about Real please visit www.realstaffing.com