Analytical Development Scientist Permanent Oxfordshire Attractive salary, plus benefits package The Analytical Scientist will be working in the Analytical Development Laboratory supporting the Pharmaceutical...
Senior Scientist/Associate Director - Analytical Development
Attractive salary & package
- As a member of the Analytical Development team, this role will support small molecule drug development programs as they advance to the clinic.
- The individual will serve as the AD team leader at the Milton Park location as well as a subject matter expert in analytical development related to bringing a compound to the clinic.
- Additionally, the role will include project team representation and scientific mentorship.
- The ability to develop novel and creative solutions to overcome project obstacles and make significant conceptual contributions to project teams are criteria for success.
- Provide science based recommendations to aid in the advancement of assets to the clinic.
- Serve as a Subject Matter Expert for analytical development, HPLC, GC, and ideally MS or NMR.
- Set and justify drug substance and drug product specifications.
- Justify and set retest period, storage, and shipping conditions.
- Understand chemical development, solid state development and formulation development.
- Develop, validate, and transfer (as applicable) analytical methods and/or supervise activities.
- Identify critical in-process-control issues and develop appropriate IPC methods and/or supervise activities.
- Design stability studies for drug substance and drug product.
- Serve as the direct contact with project teams, technical teams, and contract manufacturing and testing labs, as required.
- Present to cross functional teams and effectively communicate critical analytical issues and solutions.
- Develop, review, and approve source documents for regulatory submissions.
- Manage all activities of the group.
- Motivate personnel and resolve conflicts; assume responsibility for feedback, performance reviews, hiring and development of staff.
- Perform other duties as assigned.
- Experience in Analytical Chemistry within the Pharmaceutical Industry with a proven track record of people leadership and advancing assets into the clinic.
- Expertise in HPLC, GC, MS, and/or NMR, as evidenced by a strong record of publications, a thorough understanding of separation theory, and direct experience developing methods for small molecule pharmaceuticals.
- Knowledge of other techniques used in pharmaceutical analysis.
- Broad understanding of the drug development process, including clinical design, chemical development, solid state development, and formulation development, and the interrelationship with analytical development is essential.
- Demonstrated leadership skills and verbal and written communication skills are essential.
- Good understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development.
- Excellent interpersonal and team skills are required.
- The ability to work successfully in both a team/matrix environment as well as independently is required.
- The ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple activities are required.
- Experience in bring compounds to Phase 1 clinical trials and MS or NMR experience.
- A strong background in organic chemistry.
If you are interested in the role and have the skills required for the position please apply online by using the link provided with an recent CV and coverletter. For more information regarding this position, please call Bal on 0121 728 8455 to discuss.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.