Responsible for directing the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Ensures the effective use of material, equipment and personnel in producing quality products. May monitor and control labor and capital expenditures. May assist in developing budgets.
- Responsibility and authority for leading the manufacturing of raw material and its transformation into finished product through direct supervision and leadership of hourly manufacturing and other professionals.
- Formulates and recommends manufacturing policies, procedures and programs. Write procedures, specifications, protocols, production records and other required documents.
- Supports all applicable regulations including but not limited to FDA, ISO, and CMD/CAS requirements.
- Lead and facilitate process improvement teams, managing the technical issues that affect the production floor, and identifying and implementing capital projects.
- Select, train and evaluate staff, maintain compliance in all safety, QSR, environmental and contract areas, and exercise direct supervision over various departments and production employees with respect to meeting production schedules and delivery dates.
- Succession plans to ensure efficient operation of department.
Bachelor's degree (BA/BS) and 4 years direct manufacturing supervision experience in ISO9001, ISO13485 or cGMP environment, three (3) years in a biological products production facility subject to Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) or an equivalent combination of related work experience.
- Experience with Six Sigma/Process Excellence Tools, Training, and/or Certification is preferred.
- Prior experience in developing new product documentation, processes and practices including design transfer responsibility.
- Demonstrated leadership, facilitation and project management experience is required.
- Working knowledge of cell culture, sterile products, protein purification, in-vitro diagnostic production, and technical knowledge of infectious bacteria, viruses and related products is preferred.
- Incumbent must have excellent written and oral communication skills and be able to exhibit strong leadership, interpersonal, and teamwork skills.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
- Ability to apply concepts of basic algebra and geometry.
- Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to deal with problems involving several concrete variables in standardized situations.
Languages Fluent spoken and written English
- US-RAC required with less than five years medical device experience.
- Preferred with greater than five years regulatory experience, but not required.