Senior Process Development Engineer – Kansas
This individual will manage process developments with complexity, maintain and drive results, lead and collaborate with the project team. This role also requires communication as a single point of contact for internal teams and external customers as transfer lead for all products.
- The incumbent is responsible for process development, scale-up, technology transfer, establishing and optimizing commercial manufacturing processes for compounding and filling of solids, soft-chews, non-sterile liquids and sterile injectable (aseptic manufacturing) platforms, working closely with Manufacturing, Engineering, and Quality organizations;
- Lead the development/engineering studies and batches and generating technical protocols, reports, manufacturing documentations and performing risk based assessments to detect quality and technological risks;
- Lead Project Team that includes: a project team of internal and external staff in support of Product Transfers. This project staff could have up to 25 members and consist of more than 1 team;
- Manage and control the development of each project’s work scope and schedules required for the support of key product integrations, ensuring they are completed on budget, on schedule, and technically correct;
- Identify critical quality attributes and the strategy for defining acceptable ranges for process parameters. Understand the product and process complexity and support Validation and Quality in establishing the testing/characterization requirements for various process steps and overall manufacturing process validation;
- Develop an understanding of product stability (physical and chemical) to guide design of studies in support of product registration and regulatory submissions;
- Serve as single point of contact for internal teams and external customers as transfer lead for all product transfers. Provide proper levels of customer service, but ensuring the company’s interests are maintained. Act as key interface with internal and external resources as needed to facilitate the transfer of process knowledge to the manufacturing environment;
- Lead assessments regarding timelines, technical viability, resources, financial, investments, and communications needed to support product transfer activities;
- Support Manufacturing efficiency and operations projects by interfacing with all internal departments (Quality Assurance, Engineering, Information Technology, Validation, Manufacturing, Planning, Supply Chain Management). Troubleshoot challenges associated with process technology;
- Interact with regulatory agencies during audits and process reviews.
- Bachelor’s degree in Industrial Pharmacy, Pharmaceutics, Chemical Engineering, or related scientific field with a minimum of 7 years of industry experience in process technology development, transfers and optimization is required; Masters’ degree with a minimum of 5 years or PhD with minimum 3 years of similar experience in process technology development, transfers and optimization would be preferred;
- The candidate must have familiarity with processing equipment and technologies utilized in current Good Manufacturing Practice facilities for solids, soft-chews non-sterile liquids and injectable platforms (at least in 2 areas) and sufficient experience in process development in commercial Good Manufacturing Practice environment. A good understanding of Good Manufacturing Practice compliance requirements is essential;
- The ability to lead, manage, motivate, and direct professional technical personnel relative to changing priorities, sense of urgency, and utilization of multiple skill sets is required. The incumbent must be able to effectively interact with senior executives, senior technical managers, customers within and external to the facility. The incumbent must demonstrate high levels of value and integrity. They must instill company visions, values, and beliefs in others by example. A thorough knowledge of current pharmaceutical technology, project implementation practices and the ability to analyze problems is necessary to effectively direct the activities of his/her project team. Strong communication skills and computer literacy are mandatory;
- Experience with innovation and operational excellence is desirable.
- A good understanding of statistical analysis and ongoing process verification is desirable. Experience in leading technical cross-functional teams or relevant technical project management experience is highly desirable.
This global pharmaceutical manufacturer has expanded with a fifty-million-dollar facility, for a lucrative and transformative endeavor. As a DEA licensed and revenue-generating manufacturer in specialty pharmaceuticals, this innovative company is focused on products for hospitals and ambulatory care. Their future pipeline stands strong with developing new drugs that play nice complimentary roles to their currently successful products. The opportunities for growth are abundant with this facility in a thriving city known for its very favorable business environment.