Senior Analytical Manager, R&D
Posted 22 hours 49 minutes ago by 1100 Mylan Pharmaceuticals Inc.
Senior Analytical Manager - R&D (Injectable Analytical Group)
We are looking for a strategic, analytical leader who will be accountable for leading an injectable analytical group: developing and validating methods, characterizing structures of peptides and complex injectables with state of the art techniques. The Senior Analytical Manager will prepare technical reports for agency reviews, support product approvals, and deliver assigned R&D analytical activities in compliance with regulatory and quality criteria.
Key Responsibilities- Lead the injectable analytical team - build and structure the team; supervise, coach, and develop staff; set goals and performance metrics; manage resources and budgets.
- 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.
- Troubleshoot stability and method transfer issues, including transfers to QC or other sites; act as a key decision maker on new APIs and materials.
- Champion Right First Time (RFT) quality data, Lean lab practices, and continuous improvement.
- Ensure labs, data, and staff comply with EHS and GMP standards; partner with Quality and Regulatory teams.
- Prepare technical reports demonstrating structural and impurity profile sameness with innovator product for agency review, supporting product approval.
- Support new complex injectable product development and troubleshoot technical issues pertaining to registration based products or transfer to Quality Control for products assigned from the Injectable strategic plan.
- Relevant scientific bachelor's degree (postgraduate qualifications advantageous).
- Extensive experience in the pharmaceutical industry; combination of experience and/or education considered.
- Strong analytical chemistry expertise in peptides and injectables.
- Proven people management experience - track record of delivering results through leadership of others.
- Capability to set clear goals, communicate effectively, and ensure progress toward predefined targets.
- Experience managing resources and budgets.
- Excellent verbal and written communication skills.
- Proficient computer skills (Excel, Word, PowerPoint, databases).
- Autonomous working style, direct reporting to the R&D Product Development Senior Manager.
- Competitive salary and bonus scheme.
- Health insurance and pension plan.
- Career progression opportunities.
- Work life balance initiatives.
Viatris is an Equal Opportunity Employer. We are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience does not fully align with every requirement, we encourage you to apply - you may be the right candidate for this or other roles.