Senior Quality Control Chemist
- Employer
- Oakwood Laboratories
- Location
- Brooklyn, OH
- Closing date
- Dec 3, 2021
View more
- Sector
- Science, Chemistry, General Chemistry, Pharmaceutical, Quality Assurance
- Organization Type
- Corporate
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The Senior Chemist role will be responsible for qualification and validation of analytical methods to include:
Experience and attributes desired:
Oakwood Laboratories is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained release pharmaceuticals. This unique class of products delivers therapeutic levels of drug to patients over days, weeks, months or even years with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential.
- Writing and approving protocols and reports, including URS and FDS documents,
- Providing input and support for internal quality activities, evaluating industry best practices and implementing formal systems in the lab,
- Trouble shooting analytical instrumentation,
- Release testing on products in the laboratory and performing peer reviews of data,
- Leading laboratory investigations,
- Writing and reviewing SOPs and CCRs, and
- Training laboratory personnel.
Experience and attributes desired:
- Bachelor's Degree in a scientific discipline. Advanced degree in life sciences is highly desirable
- Five to six years' experience in a laboratory environment with at least five of those years in an industrial position involving pharmaceutical analysis
- Experience in the development of methods for analysis of pharmaceutical dosage forms
- Analytical chemistry experience with Pharmacopeial test methods
- Proficiency in lab instrumentation, including HPLC, UV vis, GC, TOC analysis, infrared instrumentation and familiarity with qualification and calibration of lab instrumentation.
- Direct experience required in a pharmaceutical manufacturing setting with knowledge of cGMPs, GLP, and GDP.
Oakwood Laboratories is a privately owned specialty pharmaceutical company focused on the design, development, and commercial manufacture of sterile injectable sustained release pharmaceuticals. This unique class of products delivers therapeutic levels of drug to patients over days, weeks, months or even years with a single intramuscular or subcutaneous injection. Products of this class have extremely high commercial potential.
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