A commercial -stage pharmaceutical company has an exciting opportunity for a Senior R&D Analyst to join its team. Alongside a team of topical drug formulation experts, you will be responsible for Analytical projects including leading and executing hands-on analytical tasks including method development, validation, and stability testing, as well as maintaining communication with external partner. You will have previous experience in the pharmaceutical industry, ideally working with topical drug formulations, and have proven analytical experience including method validation and troubleshooting.
- Support early and late phase development of projects.
- Develop & optimize analytical procedures per ICH guidelines & in-house requirements.
- Provide research & technical leadership and manage analytical projects in collaboration with external CROs/CMOs.
- Review and input analytical reports, method & validation protocols.
- Oversight of method transfers between CROs/CMOs and provide analytical expert advice.
- Ensure timely testing in accordance with protocols and delivery results.
- Identify questionable test results, perform out-of-specification investigations & initiate corrective and preventive actions.
- Attend CROs/CMOs and project meetings.
- Provide project updates in team and core meetings. Provide feedback on laboratory budget needs and lab associates' development requirements.
- Plan and prioritize monthly tasks.
- Design, implement & execute stability programs in-house.
- Provide technical training and supervise junior analysts.
- BSc in Chemistry or related scientific discipline (MSc would be considered advantageous)
- 5+ years experience in the pharmaceutical industry, preferably with topical drug formulations.
- Proven project management skills and experience in communicating with CROs/CMOs.
- Experience in designing and performing method validation.
- Experience in operating, maintaining, and troubleshooting HPLC & UPLC systems (familiarity with Waters HPLC systems and Empower software is an advantage).
- Knowledge of pharmaceutical development regulatory guidelines and ICH guidelines
- Solid experience in writing and maintaining SOPs, scientific reports, etc.
- Candidate must have the right to work in the UK.
- Must be self-motivated, possess good interpersonal skills, and able to independently handle a wide variety of work assignments and meet tight timelines.
- Candidate will work in a fast-changing environment and needs good judgment and awareness to recognize and solve laboratory/data issues.
- Good writing, communication, and time-management skills.
- Team-working and ability to plan and conclude on own working tasks.
- Proactive mentality and ability to work in a small team environment.
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6932
- Posted: 3rd September 2021
- Expires: 1st October 2021