Associate Principal Scientist, Biologics Drug Substance Commercialization – Associate Director

MSD

Lead technical and scientific efforts in biopharmaceuticals purification at a pioneering manufacturing division. Spearheading late-stage and commercial biologics development and manufacturing processes.

Posted 6/2/2026full-timeRahway • New Jersey, Pennsylvania • 🇺🇸 United StatesSenior💰 $142,400 - $224,100 per yearWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

chromatographyfiltrationprocess validationprocess characterizationtech transferdesign of experimentsstatistical process controlmultivariate analysisbiological molecule purificationpilot scale manufacturing

Soft Skills

technical leadershipmentoringcommunicationcollaborationteam leadershipprofessional developmentdata analysisproblem-solvinginterpersonal skillsinnovation

Industry Keywords

biopharmaceuticallate-stage process developmentregulatory submissionscommercial process monitoringcross-functional teamsbiologics manufacturelaboratory-scale studiesmanufacturing-scale studiesexternal contract organizationscharacterization

About the role

Key responsibilities & impact

Participate in and/or spearhead cross-divisional technical teams focused on late-stage clinical process development, characterization, and technology transfer of biopharmaceutical drug substance processes
Conduct laboratory-scale and manufacturing-scale studies to support commercial process validation and characterization
Design experiments, analyze data, and mentor junior staff, ensuring excellence in execution
Provide technical leadership in interpreting trends from commercial process monitoring, driving further investigations and process improvements
Actively interact with internal and external partners, representing your functional area on cross-functional teams to foster collaboration and innovation
Author regulatory and technical documentation, ensuring all processes align with our company’s expectations
Manage a small team of junior staff, guiding them in their professional development

Requirements

What you’ll need

A degree in Biological Sciences, Chemical Engineering, Biological Engineering, or Chemistry with relevant experience
Ten (10) years of required experience with a bachelor's degree, Eight (8) years with a master's degree, and Four (4) years with a PhD
Proficient in the purification of biological molecules, including chromatography and filtration systems
Proven track record in tech transfer or scaling up processes for biologics manufacture
Exceptional oral and written communication abilities to articulate complex concepts in a multi-disciplinary team environment
Experience leading teams and fostering career development for junior staff
In-depth knowledge of harvest, preparative chromatography, and filtration techniques (preferred)
Experience in pilot or commercial scale manufacturing of biological molecules (preferred)
Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations (preferred)
Proficiency in statistical methods for design of experiments (DOE) and data analysis, as well as statistical process control (SPC) and multivariate analysis (MVA) (preferred)

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days