Principal Scientist, Preclinical Development Rahway, NJ
Our Development team ensure production can be scaled up whilst remaining stable, effective, deliverable and safe. Following formulation, cutting edge computer modelling techniques are used to simulate outcomes and, if successful, PKPD and toxicity studies bring the science one step closer to giving hope to patients.
The Analytical Sciences department in Rahway, NJ has an opening for a Principal Scientist with a background in drug product development. Our team works within the Pharmaceutical Sciences organization which is responsible for the development of drug product in our Research and Development (RD). 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 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 focused research teams of analytical scientists who are responsible for ensuring successful formulation development via development of suitable chemical and physical methods for research and regulatory needs (including rgulatory submissions). The Principal Scientist will be a thought leader within Pharmaceutical Sciences with respect to the application of measurements to lead formulation development. In addition, you will contribute to the department's efforts towards effective collaboration with internal stakeholders, building strategic external partnerships, and to develop or identify and recruit new and innovative technologies to solve complex problems.
Your main responsibilities will include:
Planning and successful execution of analytical strategies to support formulation development and troubleshooting
Analytical leadership support to drug development and innovative technology teams
Scientific leadership in support of small molecule formulation development for both solid and sterile formulations.
Authoring/reviewing IND, IMPD, and NDA/WMA submissions as well as responses to agency questions
Strong collaboration with internal stakeholder.
Presentation of results to teams 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. A strong, documented track record of problem solving is required (through publication and lecture record).
Skills Required This role requires an advanced degree in Organic or Analytical Chemistry or equivalent and ideally a PhD degree with extensive industrial experience. The applicant should have some prior experience leading scientific staff.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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