Brief Description:

A key contributor within the Team, having the following responsibility and accountability. Responsible for planning, execution and reporting of all aspects of project related work. Hands on approach to all aspects of work to ensure mentorship and team strength is achieved. Achievement of all departmental and project related goals in a timely manner.

Accountable for applying appropriate scientific rigor, building in quality and managing risk to ensure good quality, scientific outcomes. Demonstration of collaborative and positive behaviors.

An appropriate level of knowledge and experience will be required to mentor junior team members and provide key scientific expertise as input to various projects within the department in support of functional matrix teams for robust, phase appropriate development of oral liquid and solid dosage drug products.

Essential Functions/Responsibilities

• Maintain and provide in-depth knowledge and expertise on the drug development process and relevant new technologies.
• Practical and theoretical understanding in a range of scientific skills and technologies associated with drug substance and drug product development/ manufacture at all lifecycle stages.
• Demonstrate competency and innovation on a range of complex skills and instruments, associated with the characterisation of oral liquid and solid dosage forms.
• Contribute toward process driven continuous improvement initiatives with consideration for the team, the department, and the company.
• Record and review all experimental outcomes in an appropriate format and support junior scientists to ensure the same high standards are maintained across the team.
• Lead and mentor in the design of protocols and experimental work
• Report and communicate project outcomes in an appropriate manner.
• Identify and resolve promptly any problems occurring at any phase of a study, escalating to the line manager where necessary.
• Maintain all areas of the laboratory in a safe, clean and tidy state.
• Maintain a safety first approach and ensure that cGxP is followed at all times.
• Ensure training record is maintained to cGxP.
• Ensure all applicable quality measures are met and adhered to.
• Assist in the creation and maintenance of all relevant cGxP documents.

• The role holder is responsible for maintaining cGxP and Health and Safety Knowledge relevant to the role.
• Write or constructively review S.O.P’s, Protocols, technical reports, risk assessments as required.

Required Knowledge, Skills, and Abilities

• Relevant working knowledge of material science principles applied to pharmaceutical development, including excipient functionality, solid-state characterization, and stability.
• Experience with material characterization techniques such as DSC, TGA, XRPD, SEM, Microscopy, particle size analysis, and rheology.
• Understanding of material properties and their impact on drug product performance, manufacturability, and lifecycle development.
• Knowledge of regulatory expectations related to material science in pharmaceutical development (e.g., ICH guidelines, compendial standards).
• Demonstrated experience in supporting drug substance, formulation and process development through material science insights.
• Ability to troubleshoot technical issues related to material attributes and propose science-based solutions.
• Proven communication skills, including technical writing, presentation of complex data, and cross-functional collaboration.
• Authorship of technical documentation, including material risk assessments, characterization reports, and regulatory submission content.
• Ability to coach and mentor junior scientists and contribute to capability building within the team.

Required/Preferred Education and Licenses

• Degree plus appropriate industry experience or PhD in a relevant field with appropriate industry experience.
• Awareness of risk management principles desirable.

Awareness of project management principles desirable.