Associate Principal Scientist, Analytical Chemistry – Inhalation Product Development Full-time

Associate Principal Scientist, Analytical Commercialization Technology

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 position is seeking applicants with deep knowledge and experience in inhalation product development and characterization.

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, analytical testing and characterization is required. Applicants must have effective organizational skills, multi-tasking, problem solving, and oral and written communications skills.

Education Minimum Requirements:

• PhD in Analytical Chemistry or related discipline with 3+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 8+ years of relevant pharmaceutical development experience or BS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience

Required Experience and Skills:

• Experience with inhalation product development, characterization and testing including aerodynamic particle size distribution (APSD), delivered dose uniformity (DDU), metered dose uniformity (MDU) and particle size distribution (PSD)
• 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
• 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

Preferred Experience and Skills:

• Experience with method development and validation
• Familiarity with authoring relevant CMC sections of regulatory submissions

Required Skills:

Analytical Chemistry, Analytical Development, Chemical Synthesis, Computational Chemistry, Dry Powder Inhalers (DPI), Gas Chromatography Analysis, Gas Chromatography-Mass Spectrometry (GC-MS), High-Performance Liquid Chromatography (HPLC), Inhalers, Karl Fischer Titrations, Lead Optimization, Product Development, Spectrophotometry

The salary range for this role is $142,400.00 – $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

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.