Merck · 7 hours ago

Senior Scientist - Molecular Biology

West Point, PA

Full-time

Hybrid

Senior Level

8+ years exp

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Comp. & Benefits

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Responsibilities

Design, develop, and complete validation for molecular based assays to support release, characterization testing, and process development.

Build and maintain technical expertise in analytical assay development and testing.

Author technical documents according to regulatory requirements and business practices.

Demonstrate multitasking, prioritization, and problem-solving skills for testing vaccine products.

Contribute to regulatory filing documents and technical advances in the field.

Collaborate in a fast-paced, multidisciplinary team environment.

Qualification

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VirologyMolecular BiologyMicrobiologyScientific WritingProject ManagementProblem-SolvingCreativityInterpersonal SkillsBiosafety TestingCompendial RequirementsCFR RequirementsICH RequirementsWHO RegulationsEMA RegulationsFDA RegulationsElectronic Laboratory Notebook Documentation PracticesBiopharmaceutical IndustryCGMP PracticesBiologics ManufacturingVaccine ManufacturingGMP Manufacturing

Required

A Ph.D.; or a master’s degree with a minimum of 5 years’ experience; or bachelor’s degree with a minimum of 8 years’ experience in virology, microbiology, molecular biology, biological sciences, or related discipline in the biopharmaceutical industry.

Strong background and direct experience with a variety of virology, molecular biology, and microbiology techniques to understand and solve diverse scientific questions.

Demonstrated scientific ability through publications in peer-reviewed journals and presentations in scientific conferences.

Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.

Ability to deliver complex objectives under strict timelines in a rapidly changing environment.

Ability to work in a diverse, cross-functional team environment.

Preferred

Working knowledge of regulatory and industry guidelines in the area of biosafety testing, including compendial requirements, CFR and ICH requirements, and WHO/EMA/FDA regulations.

Familiarity with electronic laboratory notebook applications and good documentation practices.

Prior work in a biopharmaceutical industry and knowledge of cGMP practices

Prior background in biologics and/or vaccine GMP manufacturing or analytics.