Akorn 2 Sr. Process Development Scientist - 256BR in Vernon Hills, Illinois

This job was posted by https://illinoisjoblink.illinois.gov : For more information, please see: https://illinoisjoblink.illinois.gov/ada/r/jobs/5284149 The Senior Process Development Scientist will provide technical expertise across the entire portfolio of Sterile products/Semisolid Process Development Activities. This position is responsible for developing process of multiple projects simultaneously, involving all aspects process development, optimization, Technology Transfer at multiple stages. The successful candidate would be expected to identify and assess new processing technologies in order to expand the organizations manufacturing capabilities, as well as assist in the process validation activities. Responsibilities include cGMP manufacture of finished products at pilot scale and transfer of new products to commercial scale.

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Key Responsibilities Include But Are Not Limited To

Process development/ improvement/optimization initiatives and creative solutions for Liquid and Lyo Injectables and Semisolid dosage forms

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+ Coordination between R&D and manufacturing/ contract manufacturing organizations (CMO).

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+ Prepare process flow diagrams.

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+ Prepare Protocols and execute Engineering batches and process verification batches

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+ Conduct Small to pilot scale batch trials with “Quality by Design” approach

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+ Scale up formulations processes from bench scale to clinical or exhibit batch scale, which can successfully be further scaled up to commercial batch scale.

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+ Execute and oversee technical transfers, scale up and clinical manufacture at internal and external drug-product GMP facilities.

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+ Support with Launch batches and Validation Batches.

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+ Prepare Product Development report based on “QbD” guidelines and other required documents.

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+ Prepare ppt presentation before and after execution of trials.

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+ Any other task as assigned.


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nQualificationsn

Minimum Requirements:

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+ BS in pharmacy/pharmaceutical science, chemical engineering, chemistry, health sciences, or related field with 5+ years of process development/validation experience or MS/PhD with a minimum of 3+ years of experience.

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+ Strong technical professional in the development/optimization of manufacturing process including compounding and filling operation of sterile formulation and topical formulations

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+ Familiar with different container closure systems for Injectables and Semisolids

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+ Have sound knowledge of regulatory expectations, cGMP, ICH and Supac guidelines.

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+ Must have strong experience in aseptic technique, lyophilization and Semisolid.

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+ Knowledge with common analytical equipments (e.g. ph meters, osmometer, viscometer etc.).

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+ Strong communication skill

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+ Strong presentation skill

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+ Must be able to use microsoft word, excel, power point and visio. Familiar with JMP or Minitab software

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+ Desired to have experience with PLC controlled equipment's


Proven ability to handle and prioritize multiple tasks and projects simultaneously

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nCompany Overviewn

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, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.

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nEEO Statementn

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 pr ctices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.