Job Description

Durham, NC


Contract Duration: 12-36 months


Rate: Negotiable


Salary: NA $1.00


Responsibilities:

• Excellent employment opportunity for a Research Associate in the Durham, NC area.
• Support company MDI product development from product definition stages to product approval and launch by devising and conducting analytical experiments.
• Under general guidance, design experiments and conduct analytical experimental work related to advancing company product quality and performance.
• Able to identify aberrant data and effectively communicate observations to project management.
• Participates in the development of an investigational plan.
• Under general guidance, begins to develop project leadership skills.
• Effectively document experiments and results in appropriate formats.
• Under general guidance, prepare technical reports and/or CoAs to summarize data and document experimental conclusions.
• Under general guidance, evaluate data for trends indicative of product performance, method performance, or analyst performance.
• Mentor junior staff members on analytical technique, technical writing, or development of technical judgment.
• Communicate project status and concerns to management.

• University Degree (BS) in the field of chemistry, pharmaceutical science, or related field.
• Three or more years of experience testing inhalation products preferred, especially MDIs, with a variety of active pharmaceutical ingredients at different stages of development.
• In-depth knowledge in at least one relevant field: HPLC, GC, KF moisture testing, MDI performance testing.
• 0-5 years of experience
• Chemistry degree (BS)
• HPLC experience preferred
• GMP experience preferred
• Familiarity with relevant ICH, USP, EP, and FDA guidance documents as well as cGXPs in support of MDI product testing.
• Must be able to effectively communicate verbally and through technical writing (documentation of laboratory experiments).
• Must be able to operate a PC and sit for extended periods of time.
• Some lifting required (not more than 50 lbs.).
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must be willing to shave facial hair for respirator use as part of lab responsibilities as needed.

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