Senior Scientist – Regulated Molecular Bioanalytics/Automation

Senior Scientist Regulated Molecular Bioanalytics / Automation

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Job Description

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products.

Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Scientists in the Regulated Immunogenicity and Molecular Bioanalytics team within Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) at Spring House Innovation Park contribute to the vaccine and biologic therapeutic area through development, optimization, validation, clinical and pre-clinical testing.

This specific position will support the molecular team and the individual should have a comprehensive knowledge of the principles and concepts of molecular biology as it pertains to method development and sample testing.

The successful candidate will provide input into the design of experiments to optimize methods, evaluate new techniques, validate, and trouble-shoot molecular assays and test pre-clinical and / or clinical samples as needed.

Experience in qPCR, DNA / RNA nucleic acid extraction, NGS and characterization in animal tissue is desirable. Extensive experience with automation and some programming skills is preferable.

The responsibilities of the Senior Scientist will be to work collaboratively in a fast-paced environment to contribute to the support of the vaccines and biologics pre-clinical and clinical studies.

The candidate will leverage the understanding of molecular characteristics impacting bioanalytical procedures supporting pre-clinical and clinical studies.

The successful candidate will also serve as a subject matter expert, providing technical support as needed to internal as well as external laboratories.

Qualifications

Education Minimum Requirement :

• B.A. / B.S. in Biochemistry, Molecular biology, Microbiology, Bioinformatics, or equivalent bio-related science with 7+ years of relevant industry experience
• M.S. in Biochemistry, Molecular biology, Microbiology, Bioinformatics or equivalent bio-related science with 4+ years of relevant industry experience
• Ph.D. in Biochemistry, Molecular biology, Microbiology, Bioinformatics or equivalent bio-related science with 0-3 years of relevant industry experience

Responsibilities :

• Ability to generate quality data to support IND and / or BLA filings.
• Strong organizational and project management skills.
• Communicate results effectively in presentations to stakeholders and to author technical reports.
• Respond to regulatory authorities pertaining to bioanalytical strategy and execution.
• Serve as an internal subject matter expert on developed assays.
• Provide input on method development reports and test method optimization.
• Demonstrates urgency and sensitivity to meet project timelines.

Required Experience and Skills :

• Experience executing routine molecular assays, data interpretation, and quality control techniques.
• Experience with Biomek liquid handling and fully integrated automation tools is highly desirable.
• Experience with programming in statistical analysis (e.g., R, Rshiny, Python etc.) is preferable.
• Ability to follow established procedures, develop new protocols, and strong attention to detail.
• Strong verbal and written communication skills.
• Proven experience thinking critically and solving complex technical issues.
• Experience with GxP, electronic laboratory notebooks, and working in a regulated lab environment.

Preferred Experience and Skills :

• Experience working in a regulated environment, GCP, GLP or GxP.
• Experience authoring responses to regulatory agencies.
• Experience in end-to-end robotics for molecular bioanalytics.

Your role at our company is integral to helping the world meet new breakthroughs that affect generations to come.

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