Summary:
Develop/implement robust manufacturing processes and procedures within regulatory compliance and adherence to cGMP. Support manufacturing in day-to-day operations. Facilitate Compounding operations in continuous improvement activities. Team collaboration with multiple departments toward formulation process improvements. Develop and coordinate processes Improve consistent product quality performance and reduce cost through analysis of manufacturing methods, processes and optimum utilization of personnel and other resources. Improve safety, reduce waste while stream-lining processes throughout the operation.
Essential Duties and Responsibilities:
- Develop, implement, and optimize robust manufacturing processes using current assets when possible
- Manage projects to meet agreed upon specifications and timelines
- Develop, prepare, review & approve master formulation records
- Assess the operation to determine corrective and preventive action plans geared towards continuous improvement.
- Develop and implement procedures that are compliant with internal safety measures, procedures, and guidelines. Ensure compliance with associated regulatory agency requirements.
- Collaborate closely with multiple departments- Operations, Procurement, Quality, Engineering in the implementation of new products and processes. Transfer knowledge obtained to all department employees.
- Support and maintain an atmosphere that encourages continues improvement and team-based problem solving.
- Design, identify, and/or investigate new technologies that will result in process improvements and support both short- and long-term goals.
- Analyze existing production methods, recommend and implement approved modifications necessary to improve product quality, reduce cost, streamline the manufacturing process, reduce cycle time and optimize utilization of personnel and other resources.
- Direct and assist in conducting root cause analysis.Assist in the development of corrective action training programs as a result of root cause analysis.
- Communicate with company personnel on projects, priorities, timetable and budgets, as necessary.
- Ensure that required formula batches are consistently performed Right First Time and identify opportunities for improvement.
- Provide leadership to and mentor Engineer Processing
- Exhibit team player qualities of cooperation and coordination; professional interaction in all business contacts, all day, every day
- Present for work when scheduled is a mandatory function. Work hours may extend past normal business hours based on the workload of the department and production schedule.
- Troubleshoot substandard manufacturing batches, assist with root cause analysis, implement corrective/ preventative actions and with 24/7 availability
- Monitor scale-up batches in manufacturing both on-site and at contract manufacturers
- Provide design and implementation support for any plant equipment changes or new equipment that would affect production of formulas
Supervisory Responsibilities:
None
Education Requirements:
A bachelor’s degree in chemistry, engineering or related science; five years of related experience and/or training; or combination of ten years’ education and experience.
Experience Requirements:
- At least 5 years of chemical processing experience within a manufacturing environment
- Ability to interact and communicate well with people
- Experience with MS Word, Excel and Power Point reporting tools and all Microsoft applications
- Ability to work with mathematical concepts such as probability and statistical inference and apply concepts such as fractions, percentages, and ratios to practical situations
- Exhibit ability to analyze data and create/implement improvement processes/programs
Competencies:
- Knowledge of chemistry and process engineering necessary.
- High degree of continuous improvement and demonstrated problem solving ability.
- Must have thorough understanding of manufacturing practices, including cGMP and FDA regulations.
- Excellent written and verbal communication skills are critical.
- Excellent organizational skills, with the ability to prioritize and execute tasks in a fast-paced high-volume environment required
- Ability to manage and report on progress of multiple projects through the organization
- Solid understanding of the commercialization process
- Preference towards collaborating on group projects rather than working individually
- High standards for quality of work
- Enthusiastic, with a positive attitude and passion for innovation and learning
- Efficient management of time and use of resources
- Intrinsic drive for results to support team goals by learning and applying new skills and concepts
- Good listening skills and willingness to accept constructive criticism and learn from mistakes
- Logical approach to judgement and decision making based on original thinking, direct experience, and high quality, independently verifiable evidence
Certificates, Licenses, Registrations:
None
Travel:
None
Work Environment:
This job operates in manufacturing environment exposed to typical production plant conditions, including some inside and outside conditions. Employee will be exposed to sufficient noise to cause worker to shout in order to be heard above the ambient noise level. Fumes or airborne particles as well as chemicals (corrosive materials like acids/bases). This job will also require working in professional laboratory and office environment. This role routinely uses standard laboratory equipment and standard office equipment such as hot plates, pH meter, viscometer, Ross miles foam height apparatus, mixers, homogenizers, balances, and computers.
Physical Demands:
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 accommodation 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 stand, walk, sit, reach, climb, stoop, kneel, talk and hear, use hands to finger, handle, feel, exert up to 20 pounds of force to move objects, and lift up to 25 pounds. Light physical work.
