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Company

Original Job Post

Merck · 2 days ago

Associate Principal Scientist, Biologics Process Development

Kenilworth, NJ

Full-time

Hybrid

Senior Level

$136K/yr - $213K/yr

6+ years exp

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Comp. & Benefits

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Responsibilities

Participate in and/or lead biologic downstream process development for first-in-human and commercial processes by efficiently developing high yield, robust and scalable processes.

Responsible for process characterization and regulatory filings to ensure a smooth and clear path to successful commercialization.

Collaborate with upstream process development, Biologics Analytical R&D, and other cross-functional teams in both Research and Manufacturing to advance biologics pipeline.

Advance downstream platform processes through creative process improvement initiatives to increase operational efficiency and reduce costs.

Assess new technologies, and industry strategies that are relevant to our company.

Collaborate with academia, industry partners, and vendors to drive development, innovation, and adoption of new process technologies.

Keep up to date with the external patents and literature; actively present and publish externally and pursues patenting strategies.

Mentor junior scientists.

Qualification

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Protein PurificationDownstream Process DevelopmentTechnology DevelopmentExperimental DesignCMC DevelopmentMatrixed Team CollaborationVendor CollaborationProblem-SolvingCommunicationInterpersonal SkillsTeam LeadershipHigh Throughput ExperimentationAutomation PlatformsProcess Control SystemsContinuous Processing StrategiesConjugation ChemistryData ScienceDownstream ProcessesPredictive ModelingMultivariate Data AnalysisMachine LearningArtificial IntelligenceProcess Analytical Technologies

Required

Ph.D. in Chemical/Biochemical Engineering, or a related field with 3+ years of experience OR

Master’s in Chemical/Biochemical Engineering, or a related field with 6+ years of experience OR

BS with 8+ years of industry experience and background in Chemical/Biochemical Engineering, or a related field

Scientific understanding of the engineering principles for recombinant protein purification unit operations. Proven ability to design and execute protein purification experiments independently.

Proven record of accomplishments in downstream process and technology development with a scientific publication and presentation track record.

Ability to direct the planning, execution, analysis, and documentation of all stages of downstream process development.

Excellent verbal/written communication and interpersonal skills.

Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors.

Knowledge of biologics CMC development cycle

Demonstrated ability for taking initiative, creativity, and innovation in problem-solving.

Capacity for team leadership

Preferred

High throughput experimentation using automation platforms.

Using and/or programming process control systems

Integrated and continuous processing strategies and equipment

Conjugation chemistry

Data science approaches related to downstream processes and predictive modeling (multivariate data analysis, machine learning/artificial intelligence leveraging Process Analytical Technologies)