Lead Research Engineer/Scientist I- Formulation

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Location

Waltham, MA

Summary

The Lead Research Engineer/Scientist I - Formulation 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.  

Full Description *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 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.

Supervisory Responsibilities:
• Instructs junior associates and trains new employees in the Pharmaceutical Development group for process development operations and physical characterization of materials.

Qualifications:

• 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.

Computer Skills:

• 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.

Physical Demands:
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.

Work Environment:
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.