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Merck · 1 week ago

Associate Principal Scientist, Engineering

USA - New Jersey - Rahway

Full-time

Hybrid

Lead/Staff

$142K/yr - $224K/yr

8+ years exp

Merck is a leading company in the pharmaceutical industry, and they are seeking an Associate Principal Scientist in Engineering to join their Chemical Commercialization Technology department. This role involves developing safe and robust manufacturing processes, providing scientific expertise, and mentoring junior staff while ensuring compliance with Good Manufacturing Practices.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

H1B Sponsored

Responsibilities

Develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline

Provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments

Perform hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities

Mentor junior staff to initiate, plan and execute characterization and complete technical support objectives

Exhibit a mindset of safety and quality compliance, including following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs)

Qualification

Chemical EngineeringProcess DevelopmentTechnology TransferManufacturing Process ValidationData AnalysisStatistical DesignManufacturing PracticesDetail-OrientedTechnical WritingMentoringCommunication SkillsCollaboration Skills

Required

The position requires a BS and/or MS in Chemical Engineering or a related field from an accredited college/university plus at least 8 years of relevant work experience in process development or PhD with at least 4 years of relevant work experience post PhD defense

Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity

Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory

Ability to mentor technical staff in the laboratory and through data analysis

Highly effective communication and collaboration skills

Good organizational, interpersonal, writing, and time management skills

Ability to operate within a cross-functional process development team

Bioprocessing

Chemical Engineering

Chemical Technology

Data Analysis

Detail-Oriented

Maintenance Supervision

Manufacturing Process Validation

Manufacturing Quality Control

Manufacturing Scale-Up

Protein Purifications

Regulatory Submissions

Technical Writing

Preferred

Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization

Experience leading regulatory file authoring, validation planning and execution

Experience guiding internal/external technical discussions

Familiarity with statistical design and analysis tools

Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting

Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles