Lead Research Engineer/Scientist I - Formulation

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Location

Waltham, MA

Summary

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.

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 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.

  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.