North Vernon, Indiana
20 days ago
North Vernon, Indiana
- Focuses on quality by design (QbD) specific issues relating to the CTD.
Are you looking to make a career change to a rapidly growing company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you
Competitive Salary, Full time and Full Benefits
Full benefits package
Education and Experience Requirements:
- Master's degree in Chemistry ,Biochemistry, Biotechnology or related field.
- Previous 5 plus years of in a pharmaceutical manufacturing industry.
- Formulation/process development
- Write eCTD sections
- Focuses on quality by design (QbD)?specific issues relating to the CTD.
- Solid dosage manufacturing experience: formulation/process development, commercial support, and/or technology transfer.
- Planned, conducted and interpreted formulation and process development experiments for drugs.
- Developed and analyzed test samples and reviewed the outcomes.
- Comply with GMP’s, SOP’s and all regulatory documentation.
- Understanding of pharmaceutical manufacturing concepts. Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA).
- Possesses applied knowledge of root cause analysis and troubleshooting techniques. Able to apply statistical analyses and experimental design techniques.
- Must have prior experience working in the Pharmaceutical industry, using analytical techniques including HPLC and GC as well as experience with Method Development and Validation of these techniques.
- Experience with LC-MS, GC-MS and ICP would be an advantage.
- Must have knowledge of cGMPs, Quality Concepts, and Microsoft Office.
- Excellent written and verbal communication skills.
- Proficiency in MS Office.
- Strong attention to detail.
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.