RA Scientists (Epping) at Aspen Pharma Group

Requirements
Job Requirements:

• Educational Background: Bachelor’s degree in chemical engineering, Organic Chemistry, Analytical Chemistry, or a related field.
• Technical Knowledge: Strong understanding of Chemical Engineering principles, Organic and Analytical Chemistry; proficiency in statistical analysis is advantageous.
• Industry Experience: Minimum of one year of experience in a pharmaceutical, cGMP-compliant, or chemical manufacturing environment.  Experience with manufacturing technology transfer projects is advantageous.
• Documentation & Data Analysis: Demonstrated ability to compile technical documentation, critically evaluate data, and ensure accuracy in regulatory submissions.
• Software Proficiency: Strong proficiency in MS Office applications (Word, Excel, Outlook, Teams, Access, PowerPoint). Familiarity with Minitab and/or EXTEDO is advantageous.

Key Responsibilities:

• Manufacturing & Cleaning Documentation: Compile and update manufacturing and cleaning instructions in compliance with internal procedures and regulatory standards
• Technology Transfer: Provide the appropriate support to ensure adherence to all established technology transfer timelines.
• Risk Assessments: Evaluate the potential presence of elemental, genotoxic, and nitrosamine impurities following relevant regulatory guidelines.
• Process Qualification: Develop and finalize process qualification protocols and reports to maintain industry compliance.
• Process Evaluation & Improvement: Analyse and report on process performance, recommending enhancements where necessary.
• Annual Product Quality Reviews: Conduct annual reviews aligned with cGMP standards, identifying adverse trends and potential process improvements.
• Change Implementation: Implement modifications related to testing and manufacturing processes in accordance with established company procedures.
• Regulatory Documentation: Compile and update regulatory submissions, including Common Technical Documents for regulatory authorities.
• Data Management: Maintain and update relevant databases to ensure accurate capturing of Active Pharmaceutical Ingredient (API) data.

Personal Attributes:

• Strong interpersonal, organisational, and systems implementation skills.
• Exceptional attention to detail and accuracy.
• Excellent written and verbal communication skills in English, including strong report writing and document reviewing abilities.
• Ability to manage multiple tasks concurrently.
• Self-motivated and results-driven.