R&D Bioanalytical Senior Manager

Mylan Teoranta

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: 

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and 
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:

• Lead bioanalytical development activities for oligonucleotide and peptide products in R&D environment. Particular focus and practical experience required in developing and performing bioanalytical methods used in the structural characterization and QC testing of Biopharmaceutical products.

• Provides leadership in area of structural characterization for complex biopharmaceuticals (e.g. heterogeneous oligonucleotide mixture derived from natural sources) and demonstrating sameness with innovator product. Has knowledge and ability to influence regulatory authorities.

• Practical Experience required for a range of techniques and specialist capability in one or more of these areas e.g. Determination of MW (electrophoresis, chromatographic separation), Impurity characterization  (Chromatography and LCMS approaches), Biophysical techniques (NMR, FTIR, CD, Fluorescence Spectroscopy), Bioassays, DNA sequencing, Liquid chromatography techniques. Has experience of developing, running or interpreting data from these Bioanalytical approaches

Technical Leadership

• Act as bioanalytical leader and oversees bioanalytical method development strategy.

• Ensures bioanalytical methodology is validation ready.

• Provide technical support and leadership for characterization of DNA/RNA segments in a complex mixture.

• Set technical standards to comply with FDA/EMA or regional regulatory requirements.

• Independently solves bioanalytical problems and develops solutions in more unusual situations.

• Supports registration stability.

• Sets specifications for a robust shelf life.

• Plan, coordinate and manage the development activities for the assigned team;

• Can develop and grow technical expertise in group.

• Fosters an environment that leads to high performance of team.

• Development of staff

• Assists in setting clear goals and evaluates performance.

• Plans and tracks progress of the work schedules for the assigned bioanalytical team.

• Bioanalytical capability/technology to support assigned.

• Strong communication and presentation skills necessary. Ability to convey complex topics; interact and influence senior R & D leadership and external bodies to ensure project progression.

• Research based and innovative mindset essential.

EHS

• Ensure the analytical group operates to Mylan’s EHS standards.

GMP

• Collaborate with Quality and Regulatory groups;

• Ensure the analytical group follows Mylan’s q