Associate Director, R&D Engineer

Job Summary:

Responsible for the design and implementation of manufacturing processes, instrumentation, and equipment from the laboratory through the pilot plant and manufacturing scale-up. Provides expertise in engineering, design, and process and/or scale-up.  Assists the manufacturing operation in problem-solving with regard to equipment and systems. Develops and recommends new process formulas and technologies to achieve cost-effectiveness and improved product quality. Recommends processes to produce therapeutic products. Establishes operating equipment specifications and improves manufacturing techniques. Involved in new product scale-up, process optimization, technology transfer, and process validation activities. Interfaces with various departments to ensure processes and designs are compatible with new product technology transfer and to establish future process and equipment automation technology.

Responsibilities:

• Responsible for the development and implementation of clinical trial material manufacturing processes, instrumentation, and equipment from the laboratory through the pilot plant and manufacturing scale-up 
• Design and develop processes for manufacturing drug/device products and nonclinical test materials using statistics-based experimentation. 
• Responsible for following design control procedure and maintaining the Design History File.
• Involved in new product scale-up, process optimization, and technology transfer activities 
• Interfaces with various departments to ensure processes and designs are compatible with new product technology transfer and to establish future process and equipment automation technology
• Work with the in-house teams to introduce new process equipment through appropriate validation and GMP documentation (e.g., GAMP 5) to ensure compliance with regulations       
• Participates in the design and manufacturing of equipment and parts used in nonclinical toxicology studies

Skills Required:

• Good understanding of manufacturing processes – hands-on experience with automated assembly/manufacturing systems in a cGMP environment. Knowledge of PLC programming and associated controls is a plus.
• Working knowledge of fixtures and test equipment in a manufacturing environment. 
• Good understanding and use of statistical methods in experiment design and data analysis.
• Able to analyze complex problems and develop solutions or approaches to resolving them.
• Experience with process improvement projects using industry-standard methodologies such as lean/six sigma is highly desirable
• Excellent interpersonal skills to allow effective participation in project teams.
• Self-motivated person with the initiative to complete tasks independently. Must be able to work in a dynamic, multi-tasking, and cross-functional environment
• Excellent oral and written communication skills.

Education and Experience:

• B.S. or M.S. in Biomedical or Chemical Engineering, Physics, or related field, with 10+ years of process development or related experience OR
• Ph.D. in Biomedical or Chemical Engineering, Physics, or related field with 5+ years of experience in manufacturing engineering, process and/or equipment development environment
• Experience with inhalation products is a plus
• Prior experience in a dynamic, fast-paced start-up environment would be valuable
• Prior experience with Pharmaceutical / Medical Device process development is a plus.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer
• Potentially prolonged periods of standing
• Must be able to lift up to 15 pounds at times
• Must be willing to travel