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Associated Principal Scientist of Biopharmaceutics

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 legacy for over a century. 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.
The successful candidate will be responsible for informing formulation and drug product development by driving the biopharmaceutics strategy in drug product teams to achieve optimal in vivo performance. As the biopharmaceutics project representative, the candidate will be leading the development and applications of predictive in vitro, in vivo, and in silico tools, conducting pharmacokinetic analysis and modeling and translating that to drug product attributes for oral and alternate routes of administration.
Primary responsibilities include but not limited to:
+ Representing the biopharmaceutics function in Pharmaceutical Sciences drug product development teams, in both early and late stage development.
+ Proactively identifying key biopharmaceutics risks at each stage of drug product development, from first-in-human formulation to post-approval changes, and conducting hypothesis-based assessment of biopharmaceutics risks.
+ Analyzing pharmacokinetic data and conducting biopharmaceutics and PBPK modeling to drive the development of in vitro-in vivo relationships and preclinical-to-clinical translation of formulation performance, linking performance to API and formulation attributes.
+ Writing and reviewing reports to support both development decisions and regulatory product filings.
+ Collaborating with team members to identify and execute predictive dissolution testing.
+ Influencing and collaborating with partner functions and groups engaged in preclinical and clinical drug development.
Education Minimum Requirement:
+ Ph.D in Pharmaceutics, Pharmaceutical Science or related field with a minimum of four (4) years of post-graduate pharmaceutical industrial experience in biopharmaceutics evaluations of clinical formulations.
Required Experience and Skills:
+ Hands-on experience in biopharmaceutics assessment of clinical formulations via oral and/or alternate route drug delivery utilizing variety of preclinical tools/models (including in vivo, in silico, and in vitro) and clinical studies.
+ Extensive hands-on experience in absorption/PK/PBPK modeling and/or predictive in vitro techniques.
+ Strong influencing and communication skills, and demonstrated ability and creativity in solving tough problems.
+ A track record of scientific publications related to biopharmaceutics, pharmacokinetics or drug delivery evaluation.
Preferred Experience and Skills:
+ Experience in new drug product filing is a plus.
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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
EEOC GINA Supplement? at http://www1.eeoc.gov/employers/upload/eeoc_gina_supplement.pdf
OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ? proudly embracing diversity in all of it?s manifestations.
Job _Preclinical Dev Generic_
Title: _Associated Principal Scientist of Biopharmaceutics_
Primary Location: NA-US-NJ-Rahway
Requisition ID: _PRE000694_

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