FSP Scientist-Formulation & Process Development

What You'll Do

• Work as part of a multi-disciplinary development team, liaising efficiently with Formulators, Modellers, Process Analytical Technology (PAT) Scientists, automation experts, data scientists and device engineers, to plan and execute preformulation, formulation and process development activities
• Assists in the manufacture of batches of product as required, e.g. for process development, stability studies or clinical trials
• Coordinates his/her activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project deliverables
• Works with the matrix technical team to align and execute preformulation, formulation and process development activities including authoring or contributing to manufacturing batch records
• Identify and interpret any problems in the execution of experimental processes and/or in results and communicates them to his/her supervisor
• Proactively engage and seek assistance from other scientists to solve problems
• Maintains cleanliness in own work area and in communal work areas
• Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems
• Operates equipment for which he/she is trained independently with due regard for GMP and Safety
• Works to GMP/GLP as appropriate
• Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements
• Performs data management tasks including recording results effectively and in compliance with departmental guidelines in a laboratory notebook or computer with minimal supervision (e.g. tabulating and graphing results)
• Consults with supervisor when difficulties arise that cannot be readily resolved
• Prepares oral or written summaries of results with interpretation for project work
• Writes specific technical sections of internal and external reports with supervision
• Attends regular safety training and is fully aware of safety requirements for his/her laboratory/working environment
• Follows safe Laboratory and Manufacturing Practices
• Maintains accurate and complete safety records consistent with company policy and legal requirements
• Recognizes potential safety problems and takes action to rectify them

Education and Experience

MS degree in Chemical Engineering, Pharmaceutical Sciences or related field with 1-3 years of protein formulation, process development and drug delivery development experience; or bachelor's degree in chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field with a minimum of 2+ years of previous experience that provides the knowledge, skills, and abilities to perform the job.

• Is technically competent in a number of formulation/process development techniques
• Demonstrates competence and experience in proper handling, recording and analyzing scientific experimental data
• Has good knowledge of GMP requirements, SOPs and policies
• Has operational knowledge of routine laboratory/plant equipment
• Understands the basic principles, concepts and methodology governing the work performed

Preferred Requirements

• Can perform literature searches independently and understands scientific literature directly related to his/her experiments
• Can learn and apply new experimental techniques
• Has basic knowledge about regulatory requirements for sterile and oral solid dosage forms