Job Descriptions
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
The R&D Senior Analytical manager is accountable for leading an Injectable R&D analytical group developing, validating methods and characterizing structures of Peptides/Oligonucleotides and Complex Injectables with state of the art techniques. Preparing technical reports to demonstrate structural and impurity profile sameness of test with innovator product for agency review supporting product approval. Collaborating with other groups in Injectable R&D centres in India and USA. Delivering assigned R&D analytical activities ensuring these are in compliance with regulatory and quality criteria required and Mylan systems. This includes supporting new Complex Injectable product development, and troubleshooting 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 R&D Senior Analytical Manager role will make an impact:
- Manages the R&D analytical group for activities assigned within Injectable R&D
- Defines structure of group and supervises direct reports.
- Development of staff, to mentor each of them, and to look after their personal training needs, specifically, to provide training to extend their knowledge aligning with a more complex pipeline (e.g. Compliance, peptides, Oligonucleotides, method development and validation…)
- Sets clear goals and evaluates performance supporting Mylan’s Injectable business goals.
- Performs short and long term resource planning.
- Setups Analytical capability/technology to support assigned products. Provide advice on troubleshooting equipment. Be a leading force to strive for technical excellence.
- Maintains analytical budget within agreed limits for regular finance reviews.
Technical Leadership
- Sets technical standards to comply with FDA/EMA or regional regulatory requirements.
- Maintains and monitor systems ensuring robust Analytical method development and validation.
- Supporting formulation and process development studies
- Troubleshooting of problems associated with products within Registration stability.
- Sets specifications for a robust shelf life in accordance with ICH criteria.
- Troubleshooting of problems related to the transfer of methods to QC or other sites.
- Key decision maker in selection of new APIs and materials
- Supports Analytical Team leaders to have more independent technical decision making.
Operational Excellence
- Control right first time (RFT) Quality Data generation, Operational Excellence and Lean Laboratory activities for projects assigned to the analytical staff in your team.
- As a leader, actively seek to continuously improve the way we work in R&D Analytical.
EHS
- Ensures Analytical group operate to Mylan’s EHS standards.
- Analytical laboratories, data, processes and staff are always compliant.
GMP
- Collaborates with Quality and Regulatory groups.
- Ensuring that the R&D group follow Mylan’s quality systems and is compliant.
- Assist in ensuring the Analytical laboratories, data, processes and staff are always compliant.
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 15+ years of applicable experience in the pharmaceutical industry. However, a combination of experience and/or education will be taken into consideration.
- Must possess a broad knowledge of analytical method development, validation, stability testing with experience of managing a group with 8 or more employees.
- 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.
- Ability to analyse data with knowledge of statistics.
- Excellent communication skills (verbal and written).
- Proficient computer skills (Excel, word, powerpoint, databases).
- This is a highly autonomous position with direct reporting to the Analytical Laboratory Manager.
