Shorla Oncology develops innovative solutions into effective oncology treatments to improve patients’ lives. The patients’ needs are at the heart of our innovation, ensuring we deliver affordable, accessible medicines and provide a significant clinical impact.
Shorla Oncology has core values of compassion, commitment, innovation, tenacity and collaboration. At Shorla Oncology we feel passionately about the work that we do and the patients that inspire us. Our focus on oncology gives us the opportunity to truly impact lives. As employees, we are here because we want to be part of a global team, working together to bring hope to underserved patient populations. Our team is smart, collaborative, creative, compassionate and accomplished. Each day we challenge each other to work on solutions for hope while building a company and culture focused on the future. The patient is at the center of our innovation, our decisions are driven by science while our Shorla Oncology colleagues motivate us to grow and develop every day.
Shorla Oncology have an exciting opportunity for a recent graduate to join the team as Analytical Specialist working directly with the Director of Analytical Services and other senior level team members. This position will afford exposure to a broad range of operational learning opportunities and professional development. You will be a key member of the team and will work with others to bring innovative pharmaceutical products to market through the stages of the product development and introduction life cycle.
Key Responsibilities include:
- Prepare, review, and approve of technical documents including methods, qualification and validation protocols and reports, etc.
- Review and interpret of analytical data with excellent attention to details (in-process, release, stability data).
- Statistical evaluation, trending and extrapolation of stability results.
- Preparation/review of analytically related non-conformances, atypical/OOS investigations, root cause analysis, change controls, deviations, and CAPAs under the supervision of the Director of Analytical Services.
- Support of the investigation activities at contract laboratories to ensure thorough technical content and compliant documentation.
- Maintenance of the analytical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory requirements.
- Working in cooperation with contractors on method validation/transfer/data trending and routine testing (cGMP release/stability testing).
Required Experience and Education:
- Bachelor’s Degree in Chemistry or Analytical Chemistry, or equivalent experience required.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’), or equivalent combination of education, training, & experience.
- Experience with multiple analytical instruments/analytical techniques (i.e. ICP-MS, LSMS, GC, HPLC, IC) required.
- Experience with multiple chromatography software packages (i.e. Chromeleon, Empower, Open Lab, etc.) required.
- Experienced with Dot Compliance/Trackwise is favourable.
- Experience in Investigation and Technical writing would be required.
- Working knowledge of US pharmacopoeia and international standards (ICH, FDA, GMP).
- Ability to apply analytical skills and scientific technical principles in problem solving/troubleshooting.
- Familiarity with statistical methods, analysis and interpretation would be advantageous.
- Knowledge of computer applications, including MS Office, Excel (Minitab would be an advantageous).
Our offices are based in Clonmel, Co. Tipperary and we facilitate a flexible hybrid working policy where we alternate working from home for the majority of the time with regular visits to the office for in person interactions with your colleagues. You will also work closely with our commercial team and other colleagues who are based in USA.
When joining Shorla Oncology you will join a self-motivated and energetic team. Our success depends on our collaboration, camaraderie, teamwork and team spirit. You will work in a hybrid manner and have opportunities to learn and grow your career. If this sounds like the characteristics of your ideal workplace and you want to work in an exciting growing fast paced company, then we are a good fit for you.
We offer a competitive salary and an attractive range of benefits including a discretionary bonus scheme, private medical cover, employer pension contributions, generous annual leave and opportunities for upskilling and career progression.
Shorla Oncology is an equal opportunities employer.
Please send your resume to: careers@shorlaoncology.com
