Senior Analytical Manager, R&D

Senior Analytical Manager, R&D

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

The Senior Analytical Manager is accountable for leading an injectable analytical group: developing, validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity profile sameness with innovator product for agency review, supporting product approval. Delivering assigned R&D analytical activities ensuring these are in compliance with regulatory and quality criteria required. This includes supporting new complex injectable product development, troubleshooting technical issues pertaining to registration based products or transfer to Quality Control for products assigned from the Injectable strategic plan.

Every day, we rise to the challenge to make a difference and here’s how the Senior Analytical Manager, R&D role will make an impact:

• Team Leadership – Build and structure the analytical team; supervise, coach, and develop staff; set goals and performance metrics; manage resource planning and budget;
• Technical Leadership – Set technical standards aligned with FDA/EMA requirements; drive method development, optimization, and validation; provide expert input on; peptide characterization, impurity profiling, and structural elucidation; support formulation/process development; set specifications for shelf-life per ICH guidelines;
• Problem-Solving – Troubleshoot stability and method-transfer issues (e.g., transfers to QC or other sites); act as key decision-maker on new APIs and materials;
• Operational Excellence – Champion Right First Time (RFT) quality data, Lean Lab practices, and continuous improvement;
• EHS & Compliance – Ensure labs, data, and staff meet EHS and GMP standards; partner with Quality and Regulatory teams;
• Strong technical expertise in analytical chemistry (peptides/injectables), proven people-management experience, and a track record of regulatory and quality compliance in a pharma R&D setting.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• A minimum of a relevant scientific Bachelor's degree (additional postgraduate qualifications are advantageous) with extensive years of applicable experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration;
• Track record of showing how results were delivered through management/leadership of others;
• Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets;
• Management of resources and budgets;
• Development and training of team members;
• Excellent communication skills (verbal and written);
• Proficient computer skills (Excel, word, powerpoint, databases);
• This is a highly autonomous position with direct reporting to the R&D Product Development Senior Manager.