Scorpius Biomanufacturing is an innovation-driven contract research, development, and biomanufacturing organization offering clients a customized, integrated, end-to-end solution for their large molecule discovery research, process and analytical method development, cGMP manufacturing, product characterization, release testing needs, and clinical trial support. Our approach enables us to forge collaborative client relationships that move beyond the traditional service outsourcing model into full product development collaborations.
Reporting directly to the Site Head, the Head of Operational Excellence will be responsible for implementing Operational Excellence initiatives, leading Continuous Improvement efforts, identifying Value Improvement Projects, facilitating the Strategic Planning process, and training personnel on OpEx principles.
Motivating employees to improve performance by fostering a culture of continuous improvement and innovation.
Develop processes to ensure business continuity, including - Tier Boards, Kaizens, 5S, Continues Improvement Projects, Green Belt Program, Standard Work & Gemba’s
Facilitate the Strategic Planning Process and develop tracking mechanisms for site goals.
Leading projects aimed at improving operational efficiency, eliminating waste, and reducing costs.
Provide leadership and support for critical Investigations.
Provide support to Department Head and ensure programs and practices are implemented.
Develop Value Stream Maps for existing processes.
Member of the Site Leadership team
Knowledge & Skills
- Be a self-motivated, customer-oriented person with abilities to inspire and lead others.
- Excellent communication skills for all levels for both internal and external clients.
- Work professionally with colleagues and maintain flexibility with work projects.
- Think and work both tactically and strategically to provide operational needs to Scorpius’ business.
- Proficient with all Microsoft Office applications.
- Respond effectively to sensitive inquiries, to support staff and customer inquiries or complaints as well as communicate effectively both orally and in writing.
- Strong understanding of FDA regulations and cGMP requirements.
- Strong problem-solving skills and ability to work in a fast-paced environment.
Education & Experience
- OpEx certifications, SSBB, Lean qualifications preferred.
- M.S. or BS. In Business, Finance, or Biosciences related field with a minimum of 10 years in the Pharmaceutical Industry and 15 years of leadership experience with continued increases in responsibility
- Excellent analytical and organizational skills and strong communication (oral and written).
- Excellent regulatory knowledge of cGMP, or other relevant skills especially establishing internal and external quality systems and processes.
Physical Requirements and Working Environment
- Flexibility is required for working hours. Some weekend work may be needed and earlier or later start/finish times may also be required.
- While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 20 pounds.
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