Biotransformation Senior Scientist (Early Oncology R&D)

Dandelion Health Inc.; Waltham (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading company in Oncology Drug Metabolism is searching for a Biotransformation Senior Scientist in Waltham. This role involves designing biotransformation studies, delivering high-quality data for regulatory submissions, and collaborating with clinical teams. Ideal candidates will possess a PhD or Master's degree and have experience in drug development and mass spectrometry. Strong analytical skills and a proven track record in the field are essential for success.

Qualifications

• 0-4 years of experience in Biotransformation work in Pharmaceutical Industry or equivalent.
• Technical skills for operating high-resolution accurate mass spectrometers.
• Experience in metabolite identification and structural elucidation.

Responsibilities

• Design and execute biotransformation studies to assess metabolic pathways.
• Deliver pre-clinical and clinical in vitro/in vivo biotransformation data.
• Prepare technical reports, publications, and presentations.

Skills

Structural Elucidation

Biotransformation

Drug Development

High-Resolution Mass Spectrometry

Regulatory Submission

Education

PhD in Chemistry/Biochemistry/Biology/Pharmacology

Master’s degree with 5+ years of experience

Tools

Thermo Q-Exactive

Orbitrap Fusion

Job description

Job Role: Biotransformation Senior Scientist (Early Oncology R&D)

Location: Waltham, AstraZeneca

The Oncology Drug Metabolism and Pharmacokinetics (DMPK) department

Business Area

The Oncology Drug Metabolism and Pharmacokinetics (DMPK) department provides ADME/DMPK, as well as translational PKPD Modeling & Simulation support to our portfolio. We are looking for an individual who has a passion for Biotransformation and DMPK science, applied to Cancer biology.

The Biotransformation senior scientist reports to the Director of the DMPK ADME Group in Boston. In this role, the Biotransformation specialist determines major metabolic pathways by interpretation of mass spectra in biological matrices, reports data to project teams and other customers, determines the structures of metabolites using high resolution accurate mass spectrometry, identifies potentially genotoxic, reactive or active or metabolites, and highlights them to customers. The Biotransformation specialist contributes via the DMPK design leader (DDL) to the design of compounds with better properties (metabolic stability/metabolism pathways) via a detailed understanding of the mechanism responsible on a molecular level and is responsible for planning and suggestion of in vivo metabolism studies. This role is also responsible for elucidating the biotransformation pathways in humans and animals for compounds in development, including contributing to the regulatory documentation.

The role holder will contribute to Oncology DMPK by:

Designing and executing biotransformation studies to assess metabolic pathways, soft-spot identification, structural elucidation and bioactivation potential of drug candidates.

Delivering high quality pre-clinical and clinical in vitro/in vivo biotransformation data to support regulatory submissions and MIST.

Providing support for radio-labeled metabolite profiling studies from in vitro and in vivo samples (pre-clinical and clinical mass balance studies).

Developing pioneering methodologies to support this core function.

Maintaining accurate records of the study data.

Preparing clear technical reports, peer-reviewed publications, and oral presentations.

Minimum Requirements:

PhD in Chemistry/Biochemistry/Biology/Pharmacology or related area and 0-4 years of experience of Biotransformation work in Pharmaceutical Industry or equivalent or Master’s degree with 5+ years of equivalent experience.

Has the technical skills to operate and perform regular maintenance and elementary trouble shooting on high resolution accurate mass spectrometers.

Extensive experience of structural elucidation of small molecules through the generation and interpretation of high-resolution mass spectra, ideally with a focus on metabolite identification.

A strong understanding of how metabolite identification studies are carried out in drug development e.g. MIST and hADME studies.

Work with clinical teams and external partners to ensure excellent study design and timely reporting of high-quality biotransformation data.

Strong experience with strategic drug development, handling submission and regulatory documents.

As a specialist in determining the structures of metabolites (for biotransformation), including measuring levels of radioactivity and be a speaking partner to the NMR specialists.

Has a track record of productivity in biotransformation work in discovery and/or development, with a delivery focus and ability to meet timelines.

Should be able to interpret confounding data, explain results, capable of suggesting follow up experiments based on data generated
Experience of working with high-resolution mass spectrometers such as Thermo Q-Exactive or Orbitrap fusion