Novex Pharma Limited is the leading global pharmaceuticals company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Primary Duties
The primary role is to support the analytical sample testing and documentation of results for process development. He/She will be responsible for preparing buffers, managing reagent inventory, maintaining instrumentation and executing experimental procedures and reporting data in a timely manner. He/She will be a contributor in the method qualification and transfer as needed, reviewing protocols, reports as needed.
Responsibilities
80%: Execution of existing Test Methods
10%: Documentation of results
10%: Troubleshooting, control trending, assay transfer and qualification support as needed
Education and Experience Requirement
BS with 2-4 years or MS with 1-2 years’ experience in Analytical, Chemistry, Biochemistry or other biological discipline. Experience in biotechnology, pharmaceutical, or related environment. Skilled in the application of one or more technical skills. Experience in method transfers, assay qualification is a plus
Key Skills, Abilities, and Competencies
Proficiency in diverse analytical techniques like HPLC, DNA, Electrophoresis is required along with basic biochemistry laboratory techniques
Computer competency is essential with emphasis on spreadsheet-based software.
Accurate documentation and communication skills
Ability to adhere to strict cnGMP procedures when applicable is required
Strong analytical and problem solving skills
Ability to report issues as needed
Ability to work in a team
Complexity and Problem Solving
Solves routine problems of limited scope and complexity. Operates under compliance requirements and systematically seeks guidance on policies and practices
Documents data accurately and completely as per established company guidelines and SOPs. Will be able to work independently with some supervision.
Novex Pharma Limited is an active company incorporated on 30 August 1984 with the registered office located in Berkshire. Novex Pharma Limited has been running for 32 Years 11 Months. Offering true quality takes a lot more than technology. At our Irvine facility, we have combined the most appropriate resources with the best human resources. Each member of staff shares the Novex commitment to excellence and our systems are tested to exacting standards, offering full traceability on production batches and raw materials.