Associate Principal Scientist, Chemistry

MSD

23h • Hybrid

About The Position

The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include, but not limited to, analytical method development and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. The ideal candidate will have knowledge and proficiency in the following areas: separation techniques and aerosol science. Prior experience with inhalation product development and characterization is highly desired. Applicants must have effective organizational skills, multi-tasking, oral and written communications skills.

Requirements

• PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience.
• Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution
• Experience with inhalation product characterization including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD)
• Strong chemistry knowledge
• Demonstrated problem solving ability
• Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
• Ability to work in a team environment with cross-functional interactions
• Effective organizational skills, multi-tasking, oral and written communications skills.

Nice To Haves

• Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies
• Experience with method development and validation
• Familiarity with authoring relevant CMC sections of regulatory submissions

Responsibilities

• Analytical method development and validation
• Drug product testing and analytical investigations in a cGMP environment
• Drug product and manufacturing process characterization
• Drug product stability studies
• Specification development
• Manufacturing process scale-up and validation support
• Preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions
• Responses to regulatory questions
• Collaborate in a dynamic, integrated, and multidisciplinary team environment

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees