Scientist I

Apply for this position

Location

Waltham, MA, United States

Summary

The Scientist I - Formulation Development designs and executes pre-clinical and clinical formulation development efforts and associated manufacturing in the development of dry powder aerosols for pulmonary drug delivery.

Full Description

The Scientist I - Formulation Development designs and executes 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.
  • 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.
  • Interfaces and works closely with the Manufacturing Department with respect to tech transfer, process development and scale-up activities.
  • 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.

Education and/or Experience:

  • B.S./B.A. in Chemistry, Pharmaceutical Sciences, Engineering or related field with a minimum of 5 years of relevant industry experience in Formulation Development in a biotech/pharmaceutical R&D environment

OR

  • M.S. in Chemistry, Pharmaceutical Sciences, Engineering or related field with a minimum of 3 years of relevant industry experience in Formulation Development in a biotech/pharmaceutical R&D environment

Supervisory Responsibilities: None

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 in working under a GMP environment.
  • Experience with conducting manufacturing and engineering activities in a manufacturing GMP environment.
  • Experience with particle size measurements by cascade impaction and laser diffraction.

Computer Skills:

  • Must be proficient in MS Office Suite.

Other Skills and Abilities:

  • Experience with DSC, TGA, DVS, XRPD and SEM a plus.
  • Strong statistical background with knowledge of Design of Experiments (DOE) a plus.
  • Reliable, self-motivated individual with positive attitude and demonstrated ability to design experiments and interpret data independently.
  • 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.
  • Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
  • Willingness to work in a fast-paced, can-do environment.
  • Desire for continued training and growth opportunities.

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.

  • No specific physical demands.

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.