Process Improvement Specialist

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Process Improvement Specialist will help Alcami build and drive operational excellence, Lean and continuous improvement methodologies and culture across the Alcami Drug Product Business Unit (DP BU). This position will be responsible for building and maturing operational excellence systems and fundamental business processes for the Drug Product Business Unit. This role will also provide day-to-day problem-solving support, training, and coaching people on Lean methodologies to foster a culture of continuous improvement.

100% on-site position in Morrisville, NC or Charleston, SC.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

• Assist in building and training on formal Lean Operational excellence programs such as systematic problem solving, value stream mapping, After Action Reviews, Lessons Learned, and 5S.
• Help in building and maintaining visual management systems such as digital Tier boards, baseline and target metrics for key processes, and agile scrum boards, and data trackers (e.g., QMS record closure, batch release).
• Build and maintain Continuous Improvement portfolio to serve as searchable data repository, ongoing action tracker and summary of cost savings resulting from Lean projects.
• Provides support for initial and ongoing Lean events (Kaizens, Value Stream Mapping, and Lean training) to ensure consistency and proper application of Lean tools & processes.
• Work with key stakeholders across the DP BU to identify continuous improvement opportunities with a focus on improving quality, reducing costs, and increasing productivity.
• Provide day to day support by helping and coaching others to foster a culture of continuous improvement across the DP BU.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

• BS/BA degree in Business Management, Engineering, or other related field of study.
• 2+ years of Lean/Operational Excellence experience preferably in a manufacturing environment.
• Working knowledge of cGMP in a pharmaceutical or regulated environment preferred.

• Experience applying lean principles and tools such as root cause analysis, 5S, value stream mapping, etc.
• Problem solving and analytical skills including the ability to identify problems, analyze data and develop solutions.
• Strong verbal and written communication skills required.
• Strong detail orientation and organizational skills required.
• Able to collaborate and communicate across all levels of the organization.
• Able to multi-task and work in fast paced environments.
• Strong working knowledge of Microsoft Office Suite, including advanced skills with Excel.

• Up to 25% travel required.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.