Principal Scientist, Bioanalytics

EMD Serono, Inc.; Billerica (MA); On-site; USD 126,900 - 215,400; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Job summary

EMD Serono, Inc. is seeking a Principal Scientist in the NBE DMPK department to lead development and validation of bioanalytical methods for NBEs and related modalities.

You will work in a matrixed R&D environment to ensure timely, high-quality analytical deliverables and interpret complex data to support preclinical and clinical programs. The role requires a PhD in a relevant field, strong experience with ligand-binding assays and immunogenicity, and the ability to manage multiple complex

Qualifications

• PhD in Biochemistry, Biology, Chemistry, or related field with expertise in PK, bioanalytics, immunogenicity, and/or relevant sciences.
• Experience with NBEs, ADCs, AOCs, and other novel modalities.
• Experience with ELISA, MSD-ECLA, Gyrolab or related ligand-binding techniques.
• Strong experimental design, troubleshooting, and data analysis skills.
• Experience with lab instrumentation performance optimization and data reporting.
• Knowledge of Watson LIMS, GraphPad Prism, Veeva Vault or related software.

Responsibilities

• Develop and validate bioanalytical methods for molecules in discovery and development.
• Ensure timely, high quality LBA deliverables (methods, qualification, and in-vivo application).
• Lead scientific literature reviews and evaluate new analytical strategies.
• Monitor bioanalytical studies at CROs and oversee data decisions with lab managers.

Skills

Bioanalytical method development

Regulated bioanalysis

ELISA/ligand binding

Experimental design

Data analysis

Education

Ph.D. in Biochemistry, Biology, Chemistry, or related field

Tools

Watson LIMS

GraphPad Prism

Veeva Vault

Job description

Work Your Magic with us! Start your next chapter and join EMD Serono. Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients

Our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

In the New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) department, the Principal Scientist role is a scientific and operational role in Research and Development (R&D). Our company is committed to bringing transformational medicines to patients, and you will collaborate in a matrixed environment with other passionate functional experts to deliver novel biotherapeutics. You will be responsible for the development and fit-for-purpose validation of bioanalytical methods to be applied in sample analysis for molecules in discovery and development phases. Your work will support the characterization of multiple molecules and modalities, including multi-specific NBEs, antibody-drug conjugates, antibody oligonucleotide conjugates (AOCs), and other biologics, from molecule design through preclinical and clinical phases, thus fulfilling internal and regulatory requirements. Representative technologies could include innovative immunochemical and ligand binding techniques such as ELISA, MSD-ECLA, Gyrolab, and others. Additional duties will include development of complex experimental study designs, interpretation of analytical data, good knowledge of immunogenicity, and technical report writing according to current company and industry standards. You will be responsible for ensuring timely delivery, with appropriate quality, of LBA bioanalytical deliverables (method development, qualification, and its application to in-vivo animal studies), and if needed, responsible for conducting/supervising critical reagent characterization. You will be able to recommend data decisions to the lab manager by providing solid results, findings and technical solutions to project issues/problems. You will be able to conduct scientific literature research to address complex technical issues and evaluate and implement potential new analytical strategies and technologies as needed. You may also be responsible for monitoring bioanalytical studies at contract research organizations (CROs).

Who You Are

Minimum Qualifications:

• Ph.D. in Biochemistry, Biology, Chemistry, or related field, with expertise in PK, bioanalytics, immunogenicity, and/or relevant sciences.
• Experience with biological molecules (NBEs, ADCs, AOCs, other novel modalities).
• Experience with ligand binding techniques such as ELISA, MSD-ECLA, Gyrolab, and related.
• Excellent experimental design and troubleshooting skills, and excellent data analysis & data mining skills.
• Experience using, optimizing, and troubleshooting the performance of laboratory instrumentations.
• Able to conduct appropriate experiments and manage work hours and priorities to meet project timelines.
• Experience reviewing bioanalytical methods, qualifications, validations, and bioanalytical study reports.
• Knowledge of Watson LIMS, GraphPad Prism, Veeva Vault and/or related software.
• 5-7+ of professional experience in regulated bioanalysis, supporting drug discovery and/or development projects
• Fluent spoken and written English

Preferred Qualifications

• Solid understanding of translational sciences, regulatory requirements and work packages for biotherapeutics (nonclinical and clinical).
• General knowledge of disease areas (e.g. Immunology, Oncology, etc.), and an understanding of biology and pharmacology.
• Experience in a global matrixed environment.

Role will be on site in Billerica, MA

Pay Range for this position: $126,900- $215,400. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!