Job responsibilities:
- Manages manufacturing engineering staff. Hires, trains and develops staff in all areas of the department. Holds staff meetings and meets individually with staff members on a regular basis.
- Assures product and process quality by designing testing methods; testing finished-product and process capabilities; establishing standards; confirming manufacturing processes.
- Provides manufacturing decision-making information by calculating production, labor and material costs; reviewing production schedules; and estimating future requirements.
- Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
- Recommends and implements process improvements and cost savings initiatives.
- Manages technology transfer AFC projects.
- Supports new product development teams with technical expertise, manufacturing documents, specifications, real-time stability, and training.
- Manages major capital investment projects.
- Manages material, process and equipment validations.
- Manages financial performance of assigned departments. Controls spending according to approved budget.
- Provides monthly reporting, cost analyses, and reports for division management. Tracks and reports status of projects.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
Requirements
- Bachelor's degree in biological or physical science or related discipline. Advanced degree preferred.
- 5+ years related experience in immunoassay product development and transfer (HIV and/or Hepatitis experience desired)
- Experience with automated immunoassay platforms and hardware preferred
- 5+ years supervisory experience
- 4+ years in an assay development management position desirable
- Requires advanced knowledge of and application of principles and theories of the engineering profession. Expert technical skills.
- Requires advanced computer skills, specifically Excel.
- Advanced knowledge in Six sigma/lean manufacturing and DOE/experimental design techniques. Six Sigma Black belt, desirable
- Requires strong communication and negotiation skills, tact and teamwork skills, and leadership skills.
