Overall Responsibility:
We are seeking a highly motivated, experienced senior scientist or engineer to join the Pharmaceutical Development group to provide technical leadership and hands-on performance in support of Pulmatrix development programs. This position will be a lead member of the Formulation and Process Development group, which is responsible for defining strategies and developing formulations and spray drying and filling processes at pilot and commercial scales. This position will work closely across functional areas on product development teams, as well as manage external contractors. The work is highly collaborative and requires excellent communication skills and the ability to be part of a team. The successful candidate must have pharmaceutical product development knowledge to contribute to our CMC strategy for novel pulmonary formulations, and have a proven ability to meet technology research and development goals within aggressive timelines. The ideal candidate will have expertise in formulation and process development of engineered particles and aerosols for pulmonary drug delivery.
Key Tasks and Responsibilities:
– Provide key technical direction for specific aspects of drug product development;
– Design, conduct, evaluate and interpret scientific studies to drive the development and understanding of our dry powder technology platform and lead drug development programs;
– Work closely and coordinate cross-functionally with formulation, solid-state, analytical and aerosol scientists and process engineers to develop robust formulations and processes in support of development projects;
– Participate in multi-functional drug product development teams;
– Assist in the management and troubleshooting of manufacturing operations at contract sites, including directing product development studies and reviewing batch production records;
– Author protocols, pharmaceutical development reports, SOPs, and other scientific/technical documents, which may support regulatory filings;
– Present study results to Formulation and Process Development team and summaries to cross-functional project teams;
– Participate in the development of the Pulmatrix intellectual property portfolio;
– Maintain a comprehensive understanding and review of pertinent scientific literature and industry initiatives;
– Possibility of managing daily activities of junior research associates and scientists or engineers to achieve team goals.
Skills and Attributes:
– Command of physics/chemistry/engineering principles;
– Exceptional scientific, technical, and problem-solving skills with the ability to design experiments and interpret data independently;
– Strong working knowledge of statistical analysis tools, in particular experimental design and interpretation of complex data sets;
– Knowledge of formulation and process development of solid-based pharmaceutical products;
– Experience with particle engineering for pharmaceuticals, with a particular focus on pulmonary drug delivery and interpretation of aerosol, solid-state and chemical analyses a plus;
– Experience with tech transfer and/or pharmaceutical cGMP manufacturing a plus;
– Excellent technical laboratory skills;
– Reliable, self-motivated individual with positive attitude;
– Team-oriented with ability to work with junior and senior staff;
– Dedication to documentation and strong attention to detail;
– Strong oral and written communication skills, with the ability to prepare and present data to internal and external working teams;
– Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities in a fast-paced environment;
– Desire for continued training and growth opportunities, including willingness to learn new skills and contribute outside of specific area of expertise.
Education and Experience:
Minimum of a scientific Bachelor’s degree (Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences or related field) and 5+ years of relevant industry experience in biotech/pharmaceutical R&D OR a M.Sc. with 5+ years OR a Ph.D. with 2+ years. A combination of experience and/or education will be taken into consideration for position and title.
– Extensive experience in successful formulation and process development leadership and problem solving;
– Thorough operational understanding of regulatory requirements and industry standards for development of high quality development programs, including quality by design principles and risk analysis tools;
– Functional ability to work in a pilot lab and/or commercial facility;
– May require travel;
– Must be authorized to work in the United States for any employer without the need for sponsorship.
Contact: Please send a cover letter and CV to jobs@pulmatrix.com
No phone calls please and only those meeting our qualifications will receive a response.
