Sr. Principal Scientist, Genetic Toxicology Job

Sr. Principal Scientist, Genetic Toxicology-RES001873

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its 125-year legacy. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

We are seeking a Sr. Principal Scientist to join the Genetic Toxicology group within the Investigative Laboratory Sciences Department in Safety Assessment and Laboratory Animal Sciences (SALAR), and to work part-time in the SALAR Program Development group. The primary responsibility of this position is to support (Q)SAR (quantitative structure-activity relationship) assessments of chemical structures for potential mutagenicity / genotoxicity to de-risk molecules in early discovery, and to help guide the overall genetic toxicology strategy. In this role, candidate will also be expected to work collaboratively with medicinal chemists, drug metabolism scientists, and with process and analytical chemists to support the ICH M7 guideline requirements on control of mutagenic impurities in pharmaceuticals. In addition to the genetic toxicology responsibilities, candidate will be expected to work part-time in the Program Development group to apply knowledge gain while at FDA to provide consultation on regulatory submissions and review of internal data packages for filing as well as serving as a Compound Leader for a drug development candidate(s). Compound Leader responsibilities include drug development strategy and risk assessment, SALAR representation on program teams, authoring regulatory and internal program-related documents, and interacting with regulatory authorities on issues relating to drug development candidate(s).

Qualifications

Education:

- Ph.D. in Toxicology with post-doctoral experience, at least 4 years of pharmaceutical industry experience, and at least 5 years of practical FDA experience as a pharm/tox reviewer.

Required:

- Strong knowledge of chemistry and metabolism of chemicals and pharmaceuticals in the context of toxicology and genotoxicity.

- Experience with the generation and interpretation of software (Q)SAR predictions. A minimum of 5 years practical FDA experience as a pharm/tox reviewer is required, including review of nonclinical PK/ADME, safety pharmacology, general toxicology, genetic toxicology, developmental and reproductive toxicology, and carcinogenicity.

- Excellent communication (oral and written) and collaboration skills.

Preferred:

- Experience and Skills - Knowledge of investigative and mechanistic toxicology of drugs.

Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Research Support Generic

Job Title:Sr. Prin. Scientist, Research

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: No

Number of Openings: 1

Shift (if applicable): N/A

Hazardous Materials: Standard lab materials

Company Trade Name:Merck