Building An
Expert Team

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 Quality Assurance Specialist to join our growing team. This position will afford exposure to a broad range of operational learning opportunities and professional development.

Key Responsibilities include:

• Ensure that a quality management system is maintained and updated as appropriate. Develop and continuously evaluate Shorla Oncology quality systems in light of the development of the business, and make quality and operational improvements as needed through the Shorla Oncology management and change control systems, so as to comply with all requirements to satisfy the regulatory needs in the markets in which Shorla Oncology operate, including EU, US, and PIC/s standards.
• Provide quality support and oversight to distribution activities for active pharmaceutical ingredients and medicinal products.
• Assist with new product introduction and technology transfer, and supporting registrations.
• Support the reporting on the effectiveness of the Quality Management System through regular reporting and action oriented leadership. File the agreed Key Performance Metrics as required to Shorla Oncology management, and monitor performance and help identify improvement and effectiveness activities.
• Respond to Shorla Oncology queries about the state of quality in Shorla Oncology, and contracted organisations, and suppliers.
• Ensure that initial and continuous training programmes are implemented and maintained in Shorla Oncology. Ensure that staff are trained on GXP requirements and Shorla SOPs, so as to ensure competence when making quality decisions. Provide training to staff on site on GMP and GDP, as required and monitor people’s training plans for GMP and GDP compliance.
• Support the preparation, review, and approval of Standard Operating Procedures (SOPs), batch instructions, testing instructions, and records, and other necessary GMP and GDP documents, for activities related to Shorla Oncology operations, and support Shorla Oncology SOPs and policies.
• Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations, and Shorla Oncology internal audits.
• Monitoring of the manufacturing and control conditions at contract manufacturers, testing facilities, customers and distributors, through audits, or other means, and ensuring the validity of appropriate licences.
• Monitoring of the suppliers of active ingredients, excipients, packaging, and other materials, through audits, or other means, and ensuring the validity of appropriate licences and EU Written Confirmations.
• File supplier audit reports for Shorla Oncology and share results internally as needed.
• Follow up on any Corrective Actions from internal and external audits and ensure they are closed out.

Required Experience and Education:

• Education – University degree in a science.
• Professional experience – not less than 3 years, of uninterrupted work experience in the production and/or control or distribution of pharmaceuticals.
• Deputy Responsible Person/GDP experience is advantageous but not essential.

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 CV to careers@shorlaoncology.com

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 Regulatory Affairs Officer to join our growing team. This position will afford exposure to a broad range of operational learning opportunities and professional development.

Key Responsibilities include:

• Manage regulatory dossier activities for new product introductions (authoring of CMC sections for regulatory submissions) and post approval activities (variations, response to questions, annual reports, commercial marketing material submissions and pharmacovigilance submissions).
• Reviews of labelling for initial submissions and in response to questions from authorities in line with FDA guidance.
• Support the wider cross functional team with new product introduction activities and technology transfer activities.
• Support product development team including execution of literature reviews on relevant topics.
• Support the Regulatory team by collecting and collating documents for regulatory submissions from 3rd party contract development laboratory and manufacturing documentation.
• Compile responses to health authorities ensuring responses submitted on time with input from other departments as needed.
• Liaise with and support other internal departments including the Director of Quality to support implementation and maintenance of the Quality Management System (QMS) and Director of Research and Development for submission compilation.
• Support regulatory license applications.

Required Experience and Education:

• Education – A relevant honours degree in chemistry, pharmacy or a related discipline is required. A Masters/Post Grad qualification in Regulatory Affairs is preferred but not essential.
• At least 2 years experience working in a regulatory affairs position within a regulated pharmaceutical environment is required.
• Experience working with US regulations and submissions is required.
• Experience in regulatory publishing tools would be an advantage but is not essential.

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 CV to careers@shorlaoncology.com

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 passionate 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.

Due to continued success and growth, we have an opportunity for the role Technical Services Manager to join our experienced team, reporting to the Director of Operations.

The position will:

• Manage and oversee new product introduction and technology transfer, and support registrations.
• Liaise with other internal departments to ensure all necessary systems are implemented in a timely manner and in line with project plans.
• Prepare, review, and approve relevant Standard Operating Procedures (SOPs) and other necessary GMP and GDP documents, for activities related to Shorla Oncology operations, and support Shorla Oncology SOPs and policies.
• Conducting and supporting manufacturing process investigations to facilitate operational excellence and continuous improvement.
• Identify continuous improvement and implementation of process improvement and operational excellent projects and liaising with key stakeholders and external vendors to support these projects.
• Drive our team (internal and external) towards operational excellence, optimizing manufacturing processes and ensuring product quality.
• Monitoring manufacturing process compliance issues.
• Manage events as required ensuring appropriate communication within the team and external team.

The successful candidate will have:

• 10 years’ relevant experience in a cGMP pharmaceutical manufacturing environment.
• BSc in a science related discipline (Chemistry, Engineering, Biotechnology etc).
• Experience working with multiple dosage forms of drug products and in multiple manufacturing process areas such as tech transfer, process validation, process optimisation, and routine manufacture.

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.

Please send your CV to careers@shorlaoncology.com

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 Senior Analytical Specialist to join our team, 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 CV to careers@shorlaoncology.com