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- Norcross, GA
- Lisa Wilson
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Akorn Pharmaceutical • Norcross, GA
Posted 27 days ago
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Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectable, oral liquids, otics, topical, inhalants, and nasal sprays.
We seek talented Formulation Scientists at various levels to join our expanding R&D team who will be responsible for developing the final product formulation, process procedures and packaging of semi-solids, suspensions and solutions, lotions, nasal sprays, inhalations, sterile injectable and ophthalmic products etc. The Formulation Scientist positions are located in our Vernon Hills, IL facility
The following are typical duties that include:
• Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale, pilot scale developmental batches to support the final formulation and processes.
• Evaluation and selection of active, inactive raw materials and packaging components for various products.
• Formulate laboratory test batches to support product development, regulatory submissions and analytical method validation program.
• Development of CPPs, QTTPs, CQAs, and scale up manufacturing processes.
• Preparation of various study protocols to conduct in-compatibility/ compatibility studies including product contact studies with container closure system(s).
• Perform technology transfer of developed processes and procedures to scale up activities.
• Participate in activities leading to Technical Transfer, process validation and commercial production troubleshooting.
• Clearly document all data generated and report all research work performed - includes creation and documentation of study and experimental protocol, development of experimental process, identification and corrections of developmental and manufacturing issues/problems/ observations and writing formulation development report (PDR) based on Quality by Design (QbD) guidelines.
• Prepare GMP documents for Exhibit Batches including technology transfer report.
• Prepare and update daily, monthly report and Drug Development Plan on experimental activities and results.
• Familiarity with interpretation of data generated by various developmental analytical tools including HPLC, GC, Particle size, DSC, XRD, Raman, Spectroscopic, etc.
• Assist in the general operation of the R & D formulation laboratory, including maintenance of SOP’s, training and equipment validation or maintenance.
• Additional responsibilities can also be assigned to support business needs.
- The successful candidate will hold a degree in Chemical or Life Sciences from an accredited university or equivalent work experience.
- Min 5 years related pharmaceutical industry experience.
- Demonstrated abilities in the areas of formulation development, injectable (and lyophilization) background and manufacturing are required.
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.