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 quality systems and are fully compliant at all times.

• Ensure the analytical laboratories, data, processes and staff are always compliant at all times.

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:

• 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. Previous experience of analytical project lead including training and supervising the activities of junior analytical personnel.

• Must possess strong knowledge of modern bioanalytical techniques and execution of these within a highly regulated pharmaceutical laboratory. Ability to provide technical support and leadership is essential.

• Must possess excellent verbal and written communication, organizational skills and computer skills including Excel, PowerPoint, Word and email. Be able to work as a flexible analytical lead of a research development team, Quality Orientated, Tight Deadline Awareness, Housekeeping Aware. Strong technical background. Energy to achieve stretch goals. Track record of developing complex products. Excellent standard of laboratory documentation completion necessary.

• Position functions with supervision. Position may be responsible for the direct supervision of employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

• Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence.  Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

• Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so 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 the following on top of a competitive salary:

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

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. 

Viatris is an Equal Opportunity Employer.