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Specialist, Operational Excellence

Bora Pharmaceuticals CDMO
Baltimore, MD Full Time
POSTED ON 3/19/2025
AVAILABLE BEFORE 5/5/2025

Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing and packaging of complex oral solid dose, liquid, and semi-solid pharmaceutical Rx and OTC products for clinical and commercial uses.

At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain.

SUMMARY

The Specialist, Operational Excellence supports pharmaceutical manufacturing site operations. Utilizing a strong background in process optimization, lean manufacturing, and project management, the Specialist OE will focus on enhancing efficiency and productivity in an aseptic manufacturing setting. This role is crucial in driving continuous improvement initiatives, fostering a culture of excellence, and ensuring compliance with industry standards.

This individual will leverage complex problem solving, interpersonal communication, and quality-focused mindset to work with the site OE team, business process leaders and employees in support of the Bora Business System and Operational Excellence University (OEU) framework.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Lead Continuous Improvement Initiatives: Drive the implementation of Lean Six Sigma methodologies and other process improvement tools to enhance operational efficiency and reduce waste.
  • Project Management: Manage multiple projects simultaneously, ensuring timely delivery within scope and budget. Develop project plans, set milestones, and monitor progress.
  • Data Analysis and Reporting: Analyze production data to identify trends, bottlenecks, and areas for improvement. Prepare detailed reports and present findings to senior management.
  • Cross-Functional Collaboration: Work closely with production, supply chain, quality assurance, engineering, and other departments to identify and implement improvement opportunities.
  • Training and Development: Conduct training and coaching sessions for staff on continuous improvement methodologies and tools. Promote a culture of learning and development, enhancing quality of training content and delivery.
  • Compliance and Safety: Ensure all improvement initiatives comply with regulatory requirements and maintain high safety standards.
  • Stakeholder Engagement: Communicate effectively with stakeholders at all levels to gain buy-in and support for improvement projects.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Education: Bachelor’s degree in science, engineering, business management, or technical discipline.
  • Experience: 5 years of experience in a continuous improvement role, preferably within a pharmaceutical manufacturing environment. Past performance in specific continuous improvement initiatives and project management will be favored over years of experience.
  • Certifications: Lean Six Sigma Green Belt certification is preferred, but willingness to earn certification is required. Project Management Professional (PMP), Change Management, and Data Analysis certification preferred.
  • Skills: Strong analytical and problem-solving skills, excellent communication and interpersonal skills, and proficient in project management software. Experience with Power BI, Power Apps, SQL, Excel, and MiniTab or similar platforms is a plus.
  • Knowledge: Familiarity with cGMP (Current Good Manufacturing Practice) and FDA regulations

PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bora is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. Bora is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at accessibility@bora-corp.com.

Job Type: Full-time

Pay: $91,719.00 - $137,579.00 per year

Schedule:

  • 8 hour shift

Work Location: In person

Salary : $91,719 - $137,579

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