Job Description SummaryReporting to the Sr Project Mgr - Product Development at the Hobart Site, the Senior Manufacturing Engineer located at the Hobart Site, will work with Product Research and Development (R&D) at the Webster Groves Site to assist in the development, scale-up and transfer of new products to the Hobart site. As products of purchased ANDA's, other Pharma companies and internal R&D are sanctioned the candidate will execute the projects as the Technical Lead. The Senior Manufacturing Engineer will be the subject Matter Expert (SME) for Development, Scale-up, Tech Transfer, Validation and Commercialization of Oral Solid (Tablets and Capsules) and Oral Liquid Dosage Forms. In addition, the Senior Manufacturing Engineer will use problem-solving techniques to support the manufacturing of Legacy Oral Solid (Tablets and Capsules) and Oral Liquid Dosage Forms. Additionally, the candidate will resolve process difficulties, reduce waste, improve productivity and safety, and assist in training and make recommendations to the Director, Technical Services Operations as needed. The Senior Manufacturing Engineer will also provide technical support to site operations, maintenance, and manufacturing personnel for supported processes. The Senior Manufacturing Engineer will have the technical knowledge and skill sets to support all Fluid-bed related activities including developing and manufacturing of Fluid Bed Granulation, Drying and Coating plus Tableting and Encapsulation.
Job DescriptionEssential Functions
- Evaluate the feasibility of new products for development and approved ANDA's of other Pharma companies for Tech Transfer and Commercialization.
- Technically lead the products from development through Commercialization including Validation support.
- Evaluation of second source API vendors and excipient suppliers.
- Resolution of Plant CAPA's with Subject Matter Expertise.
- Evaluation of customer complaints related to physico-chemical characteristics of Dosage Form.
- Equipment (Fluid Bed Dryer) upgrades.
- Extension of Product expiry dating.
- Component changes (bottles/caps) and product monitoring.
- Product transfers between Tablet presses.
- New launches.
- Scale-up and scale-down of current commercial product batch sizes.
- Use problem solving techniques to resolve manufacturing issues, reduce cost, waste and improve quality with existing processes.
- Develop/write/execute development protocols for existing products and new product transfers.
- Support of maintenance and production activities including equipment design/set up, equipment/parts changes, and process modifications.
- Provide technical leadership in support of productivity improvement and cost reduction projects.
- Review all process changes to improve products for operation, reliability, efficiency, and safety.
- Primary resource for resolving technical process issues.
- Support productivity improvements through process upgrades.
- Support new process start-ups including equipment and process development.
- Use knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects.
- Manage development activities to ensure projects meet the development schedule requirements. Develop/write product manufacturing instructions.
- Develop/write product characterization protocols and reports.
- Complete statistical analysis of data.
- Knowledge of DOE, statistical techniques for data analysis, total quality management, Six Sigma in manufacturing.
- Strong communication skills are required to manage projects effectively. This includes the ability to direct and motivate personnel who are not in the same department or function.
Department Specific/ Non-Essential Functions and Skills
Work with Sr Project Mgr - Product Development to develop project scope and cost details for project budget preparation. Regular participation in daily Product and Process Technology meeting. Assist project engineering with installation and startup of process and product upgrade projects. Manage special projects or tasks as assigned.
Minimum Requirements
Education required/ preferred:
MS/Ph.D preferably with related technical background.
Demonstrated ability to troubleshoot pharmaceutical operating equipment and support equipment. Pharmaceutical Formulation experience and or scale-up experience with solid and liquid dosage formulations. Preferred candidate to have minimum 3 - 5 years of experience.
Experience:
This job requires strong written and verbal communication to include technical communication skills, to accurately convey technical issues and information. Understanding of solid and liquid pharmaceutical formulations and hands on experience in the manufacture of pharmaceutical products.
Preferred Skills/Qualifications:
Strong technical and mathematical aptitude.
Skills/Competencies:
Strong computer literacy-MS office products, statistical analysis (Minitab) and database usage.
Organizational Relationship/Scope:
This position requires interaction with various internal and external department heads, supervisors, and operators to coordinate Product and Process Transfers.
WORKING CONDITIONS:
55% of time will be spent in the office, 45% of time on the production floor. There may also be potential opportunities for trave
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
