Assoc Prin Sci, Sterile Formulation

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 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 screening and developing robust drug product composition, developing scalable process and defining primary packaging. The candidate will also be responsible for supporting appropriate compatibility characterization to enable processing of drug product and dosage administration in toxicology and clinical studies.   The candidate will build deep fundamental knowledge around the drug product and document experimental findings and conclusions in formulation development reports. Active participation and leadership on formulation development and project teams and interfacing and collaborating with key stakeholders to drive project milestones will be required. The candidate will also be responsible for leading and championing organizational initiatives and innovation objectives. 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 fellow scientists, and a strong desire to learn and contribute. Qualifications Education Minimum Requirement:  Masters with a minimum of 8 years or Ph.D. with a minimum of 3 years of industry experience and a Degree in Chemical/ Biochemical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or related field.    Required Experience and Skills :   The qualified candidate (Masters with minimum of 8 years or Ph.D. with minimum of 3 years) should have knowledge in drug product development. The candidate should have background in drug product development, complex formulation development, and process development reflected through industry experience and external publications / patent.    Preferred Experience and Skills:   Knowledge of 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. Requisition ID: PRE000679
Salary Range: NA
Minimum Qualification
8 - 10 years

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