Principal Scientist, Sterile Formulation Sciences
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 a seasoned product developer responsible for designing and developing sterile products for small molecule, peptide, oligonucleotide, and biologic drugs for injectable and ophthalmic routes of administration. Primary duties to support both early and late stage development candidates will include ensuring screening and development of robust drug product composition, scalable process, primary packaging, and compatibility characterization for processing and administration. The candidate will build deep fundamental knowledge around the drug product and mentor a small group of scientists during product development to ensure completion of key milestones and documentation to support conclusions.
Active leadership on formulation development and project teams, interfacing with corporate wide teams, and collaborating with key stakeholders to drive defined milestones will be required. The candidate will also be responsible for leading and championing organizational initiatives and innovation objectives aligned with organizational goals. The candidate should be willing to take initiative, motivated to excel, have a strong technical background, have excellent communication and interpersonal skills, ability to multi-task, mentor scientists, and a strong desire to learn and contribute.Qualifications
- Masters with a minimum of 12 years or Ph.D. with a minimum of 8 years of industry experience and a Degree in Chemical/ Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field.
- Experience in drug product development.
- The candidate should have the desire and ability to mentor scientists towards timebound goals.
- The candidate should have a strong track record in product development, complex formulation development and process development reflected through industry experience and external publications / patent.
- Experience in sterile product development, parenteral drug delivery, and lyophilization process development reflected through industry experience and external publications / patent is preferred.
- Experience with regulatory filings for sterile dosage forms (liquid, lyophilized, complex systems) is highly desirable.
- Course work in physiology, pharmacokinetics, biochemistry, protein sciences, chemical kinetics, transport phenomenon, polymer chemistry, physical pharmacy is a plus.
- Experience in formulation/process, definition of critical attributes for process scale-up, analytical development and experience with NDA/ BLA filing for non-conventional sterile dosage forms including ocular dosage forms or peptide therapeutics, and/or alternate delivery technologies (e.g. hydrogels, emulsions, suspensions, injectable depot) is also 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.
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Job: Preclinical Dev Generic
Employee Status: Regular
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Company Trade Name: Merck