Lead Research Engineer/Scientist I - Formulation
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The Lead Research Engineer will design and execute pre-clinical and clinical formulation development efforts and associated manufacturing in the development of dry powder aerosols for pulmonary drug delivery.
*Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Designs, conducts and coordinates scientific studies to drive the development and understanding of Acorda’s dry powder technology platform with an emphasis on particle engineering.
- Performs pre-formulation, formulation and process development activities to support development projects.
- Performs and/or coordinates testing of solid-based inhalation dosage forms for characterization of physicochemical and solid-state properties.
- Manages the Formulation Development laboratory and performs development and optimization activities geared towards the production of current and novel pulmonary dry powder candidates.
- Supports formulation manufacture for development, preclinical and clinical studies.
- Provide mass balance modeling for spray drying scale up operations
- Interfaces and works closely with the Manufacturing Department or external CMOs with respect to tech transfer, process development and scale-up activities.
- Participates in the identification and evaluation of new technologies and product opportunities.
- Authors and reviews formulation related sections for development reports, regulatory filings, and other development related documents.
- Writes and edits protocols, study reports and batch records associated with all of the activities listed above.
- Participates in the development of the Acorda intellectual property portfolio.
- Maintains a comprehensive understanding and review of pertinent scientific literature.
- Participates in the assembly, operation, disassembly and cleaning of equipment;
- Supports ongoing maintenance and operation of manufacturing unit operations.
Education and/or Experience:
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences or related field with a minimum of 5 years of relevant industry experience in Formulation Development in a biotech/pharmaceutical R&D environment.
- Master’s degree in Chemical Engineering, Pharmaceutical Sciences or related field with a minimum of 3 years of relevant industry experience in Formulation Development in a biotech/pharmaceutical R&D environment
- Relevant industry experience in biotechnology/pharmaceutical R&D preferred.
- Minimum of three years’ experience with chemical engineering unit operations relating to particle engineering preferred.
- Minimum of three years’ experience with dry powder formulation/analysis for drug delivery preferred.
- Instructs junior associates and trains new employees in the Pharmaceutical Development group for process development operations and physical characterization of materials.
- In-depth knowledge of formulation development of pharmaceuticals; preferably aerosol products.
- Expertise in particle engineering and pharmaceutical formulations, preferably with a particular focus on pulmonary drug delivery.
- Excellent technical laboratory skills.
- Experience with DSC, TGA, DVS, XRPD and SEM a plus.
- Reliable, self-motivated individual with positive attitude and demonstrated ability to design experiments and interpret data independently.
- Experience in working under a GMP environment a plus.
- Experience with conducting manufacturing and engineering activities in a manufacturing GMP environment a plus.
- Experience with particle size measurements by cascade impaction and laser diffraction.
- Strong statistical background with knowledge of Design of Experiments (DoE) preferred.
- Must be proficient in MS Office Suite.
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
- Excellent oral and written communication skills.
- Ability to effectively manage time and prioritize tasks independently to meet tight timelines and shifting priorities.
- Demonstrates dedication to documentation/data traceability and strong attention to detail.
- Demonstrates appropriate safety consciousness.
- Ability to work both independently and in a collaborative team setting.
- Demonstrates attention to detail.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Must be able to lift up to 50 lbs. as necessary.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- Must be able to work in a laboratory environment while wearing appropriate personal protective equipment.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.