Senior Scientist - Analytical Commercialization Technology (ACT)

MSD • Rahway, NJ

3d

About The Position

The Analytical Commercialization Technology (ACT) group is an R&D group responsible for analytical development of late-stage pharmaceutical products. The Senior Scientist will use innovative analytical characterization technologies to advance pharmaceutical drug product development and commercialization. The role includes analytical problem-solving, data analysis and characterization, analytical method development and validation, drug product testing and investigations in a cGMP environment, product and manufacturing process characterization, stability studies, specification development, scale-up and validation support, preparation of CMC documents for global regulatory submissions, and technology transfer for commercial manufacture. The successful candidate will collaborate in a dynamic, integrated, multidisciplinary team environment. The position is available at the Rahway, New Jersey and West Point, Pennsylvania sites, with Rahway listed as the primary location. The role is regular, first-shift, and requires 10% travel. Domestic relocation is indicated; visa sponsorship is not available.

Requirements

• PhD in Chemistry or a related discipline; no experience is required for this education pathway, or a Master of Science in Analytical Chemistry or a related discipline with at least five years of relevant pharmaceutical development experience.
• Strong knowledge of and hands-on experience in chemistry and common analytical techniques.
• 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.

Nice To Haves

• Strong background and extensive hands-on experience with common analytical techniques, including UHPLC/HPLC, gas chromatography, UV and IR spectroscopy, Karl Fischer titration, and dissolution testing.
• Listed skills include analytical method development, chemical proteomics, chemical synthesis, chemometrics, chromatography, data-driven decision making, mass spectrometry-based proteomics, method validation, motivation management, process analytical technology (PAT), protein chromatography, spectroscopy, and synthetic biology.

Responsibilities

• Use advanced analytical tools for problem-solving.
• Analyze data to identify technical insights and trends.
• Develop and validate robust analytical methods.
• Conduct drug product testing and analytical investigations in a cGMP environment.
• Characterize drug products and manufacturing processes.
• Perform drug product stability studies.
• Develop specifications and support manufacturing process scale-up and validation.
• Prepare Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions.
• Facilitate technology transfer for commercial manufacture.
• Collaborate in a dynamic, integrated, and multidisciplinary team environment.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligibility for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree