AR&D Scientist (Tech Transfer)

 

 

Major Duties and Responsibilities

• Technical review of dossier content and associated data and reports to ensure product and methodology is suitable for transfer.

• Work as part of a multifunctional team to compile risk assessments and foresee potential issues and assist in providing solutions to problems.

• Liaise with counterpart from the transferring unit to ensure detailed knowledge transfer. And where necessary 3rd party testing facilities.

• Where necessary produce and execute analytical method verification /validation protocols (including dissolution methodology).

• Compile Methods and specifications.

• Provide analytical support for feasibility studies and scale up verifications to support product transfer to plant.

• Support transfer investigations and where necessary devise suitable experimental design.

• To remain aware of developments within the scientific fields and to ensure all products, processes, and analytical methodologies reflect current best scientific practice.

• Undertakes such other reasonable duties as may be required from time to time to support the department and business activities. · Acknowledge responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.

Competencies

• Ability to work as part of a team

• Oral and written communication skills.

• Detail oriented

• Ability to meet deadlines

• Research skills

Knowledge and Experience

• Typical Years of Experience – 4-8 years experience

• Minimum Expected Education- Level 6 Bachelor’s Degree

• Additional Information – Degree in Lab based science and proven experience in laboratory techniques. Must demonstrate proficiency in HPLC and previous development of analytical methods from first principals and method validation. Knowledge of module 3 content will be required.