Scientific Associate Director, NBE DMPK Lead at EMD Serono Research & Development Institute

Billerica, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

10 Jul, 26

Salary

0.0

Posted On

11 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacokinetics, Immunogenicity, Bioanalytical assays, Ligand-binding assays, Cell-based assays, GLP, GCP, Regulatory submissions, IND, BLA, Biotherapeutics, Drug metabolism, Oncology, Immunology, Pharmacology, Data analysis

Industry

Pharmaceutical Manufacturing

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: The New Biological Entities Drug Metabolism and Pharmacokinetics (NBE DMPK) Lead is a strategic, scientific, and operational role within Research and Development (R&D). Merck Healthcare is dedicated to delivering transformational medicines to patients, and in this role, you will collaborate within a matrixed environment alongside passionate functional experts to advance novel biotherapeutics. You will be responsible for overseeing the clinical bioanalytical work conducted by external partners, ensuring methodological robustness and compliance with regulatory requirements. Specifically, you will coordinate the validation of bioanalytical assays related to pharmacokinetics (PK) and immunogenicity assessments, and perform quality reviews of bioanalytical data and reports. Throughout the studies, you will provide troubleshooting support as needed. Additionally, you will serve as an NBE DMPK lead for clinical drug development, participating in cross-functional global teams responsible for bioanalytical strategies related to PK and immunogenicity. You will also support regulatory submissions by authoring relevant sections, including those for IND and BLA filings. Who You Are Minimum Qualifications: Ph.D. in Biochemistry, Biology, Chemistry, or a related field Several years of experience in the pharmaceutical industry or CRO in comparable roles Preferred Qualifications: Strong experience with biological molecules such as NBEs, ADCs, and other novel modalities Extensive background in ligand-binding assays, with preference for experience in cell-based assays Excellent understanding of bioanalytical strategies and scientific approaches for large molecules In-depth knowledge of GLP/GCP regulations Experience supporting regulatory submissions, including authoring Integrated Summary of Immunogenicity, Clinical Study Reports (CSRs), summary sections for INDs, Investigator’s Brochures (IBs), briefing books, and BLAs General knowledge of disease areas such as Immunology and Oncology, along with an understanding of biology and pharmacology Excellent organizational and communication skills, with fluency in spoken and written English Strong intercultural awareness Mature leadership and influencing skills 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!

Responsibilities

The NBE DMPK Lead will oversee clinical bioanalytical work conducted by external partners and ensure compliance with regulatory requirements. They will also serve as a lead for clinical drug development, coordinating bioanalytical strategies and supporting regulatory filings such as IND and BLA.