OFFICIAL JOB APPLICATIONS MUST BE SUBMITTED TO THE MERCK JOB SITE AT www.merck.com
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 Analytical Sciences group in Rahway has an opening for a Principal Scientist with a strong background in drug product development. Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
In your role as Principal Scientist, you will lead a small team of Analytical scientist and be responsible for the support of pharmaceutical product development and regulatory submissions. In addition, you will contribute to the department's efforts towards effective collaboration with internal stakeholders, building strategic external partnerships, and to identify and recruit new and innovative technologies to solve complex problems.
Your main responsibilities, which are in no particular order and are by no means complete, include:
Scientific leadership in support of small molecule, peptide, and oligonucleotide formulation development in both solid oral and sterile dosage forms
Planning and successful execution of analytical strategies to support formulation development, product characterization and mitigating any technical risks
Authoring / reviewing IND, IMPD, and NDA / WMA submissions as well as responses to agency questions
Strong collaboration with internal stakeholders and external vendors
Analytical leadership support to drug development and innovative technology teams
Presentation of study results to project teams, stakeholders and internal governance bodies
Leading and Mentoring scientific staff
Representing Analytical Sciences on teams evaluating new external technologies and potential licensing opportunities
External engagement especially with a focus on regulatory strategy development related to small and large molecule containing drug products
Efficient communication with external partners via consortia and / or scientific collaborations with academic institutions
This is an exciting opportunity for an enthusiastic scientist with a clear understanding of the technical and regulatory challenges of developing complex formulations and who has excellent communication skills. Experience leading scientific professionals would be ideal.
Education Minimum Requirement:
Ph.D Degree in Organic, Physical or Analytical Chemistry or related degree plus 8+ years of relevant industry experience.
Master's Degree with 10+ years of relevant industry experience
Bachelor's Degree with 14+ years of relevant industry experience
Internal Number: PRE000685
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