Senior Principal Scientist

2 weeks ago

Rahway, New Jersey, United States Merck Sharp & Dohme Full time

Position Overview:
The Large Molecule Analytical Validation team within the Analytical Research & Development sector at Merck Sharp & Dohme is on the lookout for a dedicated Senior Principal Scientist. This role requires profound technical acumen in formulating strategies for critical reagents associated with large molecules.

Role Responsibilities:
The Senior Principal Scientist will assume a pivotal scientific position, collaborating closely with the group Director to establish strategic direction while leading a team of scientists in addressing intricate analytical challenges that intersect analytical, regulatory, and quality domains to facilitate effective commercial testing.

The successful candidate will be recognized as an authority in the development of reference standards and critical reagents, leveraging a deep mechanistic understanding of large molecule analytical methodologies.

Key Expectations:
We anticipate that the ideal candidate will bring scientific expertise and innovative thinking to navigate complex scenarios across our diverse portfolio. They will be responsible for fostering scientific excellence through the adoption of cutting-edge technologies and methodologies to enhance critical reagent management throughout the lifecycle of programs.

The Senior Principal Scientist will provide technical and scientific guidance to a team of 3-5 professionals, ensuring robust support for our large molecule pipeline.

Specific Duties Include:
- Representing the group on product development teams.
- Formulating and executing strategies for large molecule critical reagents.
- Overseeing reagent qualification and testing processes.
- Ensuring thorough documentation and providing scientific mentorship.

The candidate must demonstrate effective communication skills with management, governance teams, and various stakeholders within the organization.

Educational Background:
A Ph.D. in biological sciences, biochemistry, molecular biology, cell biology, or virology, accompanied by a minimum of 8 years of pertinent experience in the biopharmaceutical industry, or a Master’s degree with at least 10 years of relevant experience.

Required Skills and Experience:
- Profound knowledge of analytical development and technical expertise in potency assays that reflect mechanisms of action, as well as immunoassays utilized in the development of biologics and vaccines.
- Strong leadership abilities, collaborative spirit, and a commitment to mentoring, alongside effective organizational and multitasking skills.
- Proven capability to interpret complex experimental designs and detailed data analysis concepts related to analytical method validations and reagent qualifications/re-evaluations.
- Experience in monitoring reagent and assay performance, ensuring control over key quality attributes within reference standards, and conducting analytical bridging studies.

The candidate should possess a comprehensive understanding of regulatory guidelines and quality standards, with experience in devising reference standard strategies for large molecules, including vaccines and biologics such as therapeutic proteins, monoclonal antibodies, and antibody-drug conjugates. Experience in authoring and reviewing regulatory submissions and engaging with health authorities is essential.

Demonstrated scientific achievements in delivering impactful solutions to complex challenges, along with evidence of strong cross-functional collaboration and exceptional written and verbal communication skills, are crucial.

Experience with the external scientific community, including publications, contributions to regulatory guidance documents, and participation in scientific meetings or cross-company working groups, is highly valued.

Conclusion:
The ability to adapt to evolving program requirements through informed, swift decision-making, mentoring technical staff, leading projects, and defining departmental strategies will distinguish successful candidates.

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