Sr. DMPK Scientist - ADME Toxicology
Eurofins Panlabs, Inc.

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Become your most extraordinary self! Our team is intensely proud to be a major provider of services and products to the drug discovery research industry. Join Eurofins Panlabs, Inc. part of the Eurofins Discovery ™ group of companies serving global clients in the Pharma and Biotech industries. Work alongside industry experts and collaborate with team members to directly and positively impact human health worldwide!

We have a philosophy to support work life balance, career progression opportunities and offer many benefits such as formal mentoring programs, tuition reimbursement, extensive career training programs, competitive health benefits, paid time off and 10 annual paid holidays*.

Position Summary

The DMPK Scientist / Sr. Study Director is a leadership position in our global network of drug discovery services. The role will provide in lab and consultative services to support DMPK, metabolic stability, metabolite profiling, CYP, pharmacokinetic and transporter mediated drug interaction studies. Studies will aid drug discovery and development to select candidates that provide optimal DMPK properties. This position serves as a principal investigator and contributes to the strategy for successful drug candidates while supporting client project specifications. This role provides innovation and scientific leadership in our global portfolio. The Senior Study Director provides technical expertise in ADME and Toxicology methods, R&D leadership, and executive-level communication with external and internal customers

Qualifications

Basic Minimum Qualifications (BMQ)

• Extensive experience in drug metabolism, pharmacokinetics, pharmacodynamics, bioanalytical and drug interaction assays. Multi-year hands on experience in conducting and overseeing DMPK studies, operating and maintaining mass spectrometers in the practice of structure elucidation of metabolites, and degradation products. Demonstrated experience in interpreting mass spectrometry data, including crucial review of analytical data within a pharmaceutical or CRO organization.
• Experience leading Drug Metabolism and Pharmacokinetics (DMPK) studies, including method optimization, study design, scientific method, data analysis, troubleshooting, and data interpretation and communicating results to internal and external stakeholders.
• Demonstrated experience in project management, developing client relationships, supporting technical correspondence, drafting and presenting scientific proposals to clients
• Experience in leading cross-functional teams (regulatory, pharmacology, medicinal chemistry, safety) to guide advancement of molecules from development to clinical candidacy
• Demonstrated scientific contributions to the industry at large, through publications, white papers, webinars and presentations.
• Experience leading strategic business initiatives and innovation in matrixed organization
• Scientific expertise in the areas of cellular biology, in vitro assays, ion channels, ADME-T, biomarker discovery, immunology, safety pharmacology, or related methods and applications
• Proven expertise in experimental design, scientific interpretation, reporting and presentation.
• Experience leading within a quality management / regulatory framework. Demonstrated experience in method validation principles according to FDA, ICH, and OECD guidelines. Technical proficiency and knowledge of regulatory guidance and ADME Toxicology applications within drug discovery programs, from development to IND submission life cycle

Education/Experience (BMQ)

• M.A. or M.S. with 15 years relevant experience
• Ph.D. with 10 years relevant experience
• Combination of education and relevant experience in ADME, DMPK and Toxicology applications

Ability / Skills (BMQ)

• Scientific expertise in ADME, Toxicology, and DMPK applications such as bioanalysis, solution properties testing, in vitro metabolism, in vitro absorption, in vitro toxicity assessment, drug-drug interactions and metabolite ID
• Direct experience with Liquid Chromatography- Mass Spectrometry and/or ultraviolet spectrometry (LC-MS or LC-UV) Advanced experience in Liquid Chromatography - Mass Spectrometry (LC-MS) and Tandem Mass Spectrometry MS/MS for use in small and large molecule pharmaceutical development in a CRO or industry laboratory for ADME/ DMPK applications.
• Demonstrated technical knowledge of Metabolomics in regards to pharmaceutical drug metabolism. Experience supporting Metabolite ID analysis within drug development programs.
• Proficient in pharmacokinetic modeling software applications (e.g. SIM CYP, WinNonlin, Lhasa, Genedata). Proficient in metabolite identification software applications (e.g. Metabolite Pilot, MetaboLynx, Compound Discoverer) from High-Resolution Mass Spectrometers (e.g. Q-TOF, Orbitrap)
• Demonstrated proficiency in high-throughput analytical method development for small molecules
• Demonstrated experience with in-vitro applications, and development of cell based methods
• Demonstrates a positive attitude, capacity for team environment, and exhibits a genuine interest in drug discovery in support of advancing human health
• Excellent interpersonal, verbal and written skills, including ability to prepare detailed scientific reports and group presentations
• Demonstrates a working understanding of international regulatory requirements and aptitude to stay relevant on topical scientific publications
• Ability to support project management, plan and coordinate multiple projects simultaneously, with appropriate allocation of available resources
• Demonstrated experience in working effectively with lab operations, business development, marketing, and outsourcing stakeholders. Experience with leading and influencing cross-functional teams effectively
• Demonstrated experience in strategic planning and managing portfolio growth initiatives
• Experience troubleshooting and maintaining Mass Spectrometers and HPLC units. Experience with Sciex® or Thermo High Resolution/ Accurate Mass Instrumentation is a plus. Experience with liquid handling, automation ,solid-phase extraction (SPE), HTS applications, and large-scale screening

Additional Job Requirements

• Manages client projects in all phases of study life cycle from study design to reporting
• Scientific leadership in developing portfolio strategy, new growth and technology planning
• Influences scientific community through external marketing, industry reputation and brand
• Provide technical leadership to lab operations, business development and marketing team
• Supports client services team in generating proposals, RFPs, study plans and scope of work
• Leads multi-site cross-functional drug discovery programs with Eurofins affiliates
• Understands and complies with requirements for work performed within a GxP site
• Completes required training and supports 100% of Employee Health and Safety requirements
• Conducts responsible use of confidential IT and business systems, as required
• Adheres to department SOP and documentation requirements
• Manages data management and reporting, with quality assurance of project data and reports
• Accountable for delivering to unit and site key performance metrics (quality, delivery on time)
• Supports site goals and demonstrates Eurofins' competencies, as defined in the job plan
• Provides training to colleagues and external end users, when required
• Performs other duties, as assigned, and may be required to support in new growth areas

Additional Information

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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