AR&D Principal Scientist
Major Duties and Responsibilities
• Individually contribute or oversee the creation of new product specifications and test methods which
are robust and meet regulatory requirements. Prepare documents for regulatory filings / licence
variations. Design experiments and provide data to support responses to the regulatory authorities
RFI’s.
• Perform physical and chemical testing on raw material, in-process, finished product and stability
samples, including documentation and review.
• Individually contribute or oversee the development, validation and transfer activities associated with
non-complex to complex analytical methods. Individually investigate or lead investigations to
successfully resolve analytical problems, project issues and deviations. This will include leading some
investigations into product issues from QC and Operations. Accurately maintain all related
documentation in compliance with SOPs.
• Plan and manage all analytical activities in support of method development and validation (feasibility,
prototype, method development, compatibility studies, raw material evaluation, COSHH
assessments).
• Research, prepare and review of technical documents, including but not limited to, SOPs, technical
packages, raw material, release and stability specifications, stability summaries, test methods, and C
of A’s which conform to company standards.
• Attend and present data at project-related meetings, interact with internal and external parties to
ensure objectives are met. Participate in project teams, and exercise and build basic team
effectiveness skills.
• Ensure compliance of all analytical processes, facilities, equipment and activities to applicable cGXPs,
regulatory guideline, and company SOPs on a consistent basis. Conduct routine laboratory audits and
involvement in activities associated with third party laboratory audits, as required.
• Develop, supervise, and evaluate performance of team members. This includes providing technical
and procedural training and mentoring for team members and coordinating team member activities
to successfully accomplish departmental goals. Including identifying and assessing developmental
needs for all team members and addressing with developmental plans.
• Conduct technical document review for external departments. Approve analytical reports, CofA,
specifications, test methods and deviations related to own or other projects.
• Maintain interdepartmental relationships and positively promote the department and its objectives.
Remain aware of developments within the scientific fields and to ensure all products, processes, and
analytical methodologies reflect current best scientific practice.
• To assess and recommend, with financial and operational justification, new equipment and
techniques within the development department.
•Undertakes such other reasonable duties as may be required from time to time to support the
department and business activities.
Competencies
• Ability to work as part of a team.
• Oral and written communication skills.
• Detail oriented.
• Ability to meet deadlines.
• Research skills.
• Leadership skills.
Knowledge and Experience
• Typical Years of experience-8-10 years experience
• Minimum Expected Education-Level 6 – Bachelor’s Degree
• Additional Information-Should already have managed people for approximately 4 years