Analytical Scientist, PLA, PLGA, CMC, FDA, Dosage forms, Pharma Job in Solon 44139, Ohio Us
Skills Required:
Analytical Scientist, bidegradable polymers, PLA, PLGA, CMC, FDA filings, Dosage forms,phamaceutical,
Job Description:
Analytical Scientist – PLA/PLGA, FDA, CMC
Direct Hire/Perm
Location: Solon, OH – Relocation available for applicable candidates
We are currently seeking an experienced Scientist with a hands-on background in formulation of Biodegradable Polymers (PLA/PLGA) sustained release products.,
The ideally qualified candidate will also be someone who has extensive experience in/ working with the FDA and submitting filings.
Our target is to find someone with a Chemistry, Manufacturing, and Controls (CMC) background , as this person may be required to be hands on at times, but is ultimately responsible for putting filings together and interacting with the FDA.
In this role you will perform the above duties, along with assisting in the development of new analytical methods for new dosage forms, and validating new methods /troubleshooting existing methods.
The ideally qualified candidate will bring with them:
• Bachelors’ Degree in Chemistry or Analytical Chemistry, or closely related field. (Doctorate level education is applicable in calculating required experience.)
• 5-10 years of applicable experience in a laboratory environment as a Chemist with at least three (3) of those years in an industrial position involving pharmaceutical analysis, preferably at a mainstream pharmaceutical company.
• Experience must demonstrate compliance and success in working with regulatory and cGMP requirements.
• Experience with CMC documentation and FDA communications,
• Supervisory experience is highly desirable.
• Experience with the development of methods for analysis of pharmaceutical dosage forms.
Must be authorized to work in the United States on a full-time basis for any employer.
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