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Accentuate Staffing is currently recruiting for an Inhalation Manager to join an established company in the RTP area. This is a direct hire opportunity.
The successful candidate will lead a team of scientists and engineers to develop generic inhalation products:
– Subject matter expert in metered dose inhaler (MDI) product development, including reverse engineering, pre-formulation studies, formulation development, and product characterization.
– Experienced in evaluation and selection of APIs, excipients, and packaging components such as cans, valves, actuators, dose counters, and overwraps.
– Hands-on experience in MDI process development, including use of Pamasol crimping and filling equipment.
– Experienced in fine particle generation (e.g. jet milling) and powder characterization (e.g. TGA, DSC, DVS, SEM, particle size by laser diffraction, etc).
– Proficient in aerosol characterization techniques, including cascade impaction (e.g. NGI), delivered dose uniformity, total can assay, foreign particulate matter, spray pattern, plume geometry, and Karl Fischer moisture analysis.
– Skilled in statistical design of experiments (DoE). Experience with JMP is a plus. Independently plans experiments and reviews data.
– Experienced team leader
– Manages and meets timelines
– Manages supplier relationships
– Promotes a safe working environment
– Working knowledge of Quality by Design (QbD), cGMP, and US regulatory and compendial requirements for respiratory products.
– Strong written and oral communication skills. Prepares protocols, reports, and presentations.
Minimum Requirements: BS, MS, or PhD in chemistry, pharmaceutical sciences, or related field. At least seven years of experience in MDI product development, preferably in a generics environment.