Social network you want to login/join with:
R&D Bioanalytical Senior Manager, Inverin
Client: Viatris
Location: Inverin, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: d44a67eac605
Job Views: 70
Posted: 22.01.2025
Expiry Date: 08.03.2025
Job Description:
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
1. Access – Providing high quality trusted medicines regardless of geography or circumstance;
2. Leadership – Advancing sustainable operations and innovative solutions to improve patient health;
3. Partnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
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 successful candidate will provide leadership for bioanalytical development activities for oligonucleotide (synthetic or derived from natural sources) and peptide complex injectable products within R&D. Proven leadership skills and practical experience in developing Bioanalytical characterization methods is essential. Bioanalytical knowledge in DNA and RNA raw material processing and analysis of complex mixtures of purified DNA/RNA and oligonucleotides segments required. Preferably would have familiarity with DNA extraction, purification and characterization from natural sources.
Every day, we rise to the challenge to make a difference and here’s how the R&D Bioanalytical Senior Manager role will make an impact:
1. Lead bioanalytical development activities for oligonucleotide and peptide products in R&D environment, focusing on developing and performing bioanalytical methods used in the structural characterization and QC testing of Biopharmaceutical products.
2. Provide leadership in area of structural characterization for complex biopharmaceuticals (e.g. heterogeneous oligonucleotide mixture derived from natural sources) and demonstrating sameness with innovator product.
3. Practical experience required for a range of techniques and specialist capability in one or more areas (e.g. Determination of MW, Impurity characterization, Biophysical techniques, Bioassays, DNA sequencing).
4. Act as bioanalytical leader and oversee bioanalytical method development strategy.
5. Ensure bioanalytical methodology is validation ready.
6. Provide technical support and leadership for characterization of DNA/RNA segments in a complex mixture.
7. Set technical standards to comply with FDA/EMA or regional regulatory requirements.
8. Independently solve bioanalytical problems and develop solutions in unusual situations.
9. Support registration stability and set specifications for a robust shelf life.
10. Plan, coordinate and manage the development activities for the assigned team.
11. Foster an environment that leads to high performance of team and development of staff.
12. Assist in setting clear goals and evaluating performance.
13. Plan and track progress of the work schedules for the assigned bioanalytical team.
14. Demonstrate strong communication and presentation skills to convey complex topics and interact with senior R&D leadership and external bodies.
15. Maintain a research-based and innovative mindset.
EHS
Ensure the analytical group operates to Mylan’s EHS standards. Collaborate with Quality and Regulatory groups to ensure compliance with Mylan’s quality systems.
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:
1. Minimum of a Bachelor’s degree in a science-related discipline (Preferably Biochemistry or Biotechnology) with a minimum of 10 years pharmaceutical bioanalytical laboratory experience.
2. Strong knowledge of modern bioanalytical techniques and execution within a highly regulated pharmaceutical laboratory.
3. Excellent verbal and written communication, organizational skills and proficiency in computer skills (Excel, PowerPoint, Word).
4. Ability to work flexibly as an analytical lead of a research development team, with a strong technical background and energy to achieve stretch goals.
5. Track record of developing complex products and maintaining excellent laboratory documentation.
6. Ability to read and interpret complex documents, write comprehensive reports, and present to groups.
7. Problem-solving abilities with a variety of concrete variables through semi-standardized solutions.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace. If you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris
At Viatris, we offer competitive salaries, benefits, and an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. Some of our benefits include:
* Excellent career progression opportunities
* Work-life balance initiatives
* Health insurance
* Pension
Diversity & Inclusion at Viatris
Diversity and inclusion are essential to our mission. If you would like to know more about what diversity, equity and inclusion means to us, please visit.
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. To learn more about our efforts, please visit.
Viatris is an Equal Opportunity Employer.
#J-18808-Ljbffr