Senior Specialist, Engineering (Onsite)

MSD

1d • Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey. The Second Shift Sterile Process Engineer role at the Senior Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing the completion of its’ Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility startup. This role will have significant leadership potential as the first representative of our team dedicated to the second shift. Once the facility is operational, this role will support the pipeline’s most technically complex formulations and process development through process tech transfer, scale-up activities, quality investigations, change management, technical operations support, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS).

Requirements

• Excellent enterprise leadership skills demonstration
• Excellent interpersonal and communication skills, both verbal and written.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.
• Adaptability
• Adaptability
• Analytical Testing
• Chemical Engineering
• Clinical Trials Operations
• Data Analysis
• Detail-Oriented
• Deviation Management
• Equipment Qualification
• GMP Compliance
• Good Manufacturing Practices (GMP)
• Immunochemistry
• Medical Supply Management
• Medicinal Chemistry
• Organic Chemistry
• Phytochemistry
• Process Design
• Process Hazard Analysis (PHA)
• Process Optimization
• Process Scale Up
• Process Simulation
• Root Cause Analysis (RCA)
• Standard Operating Procedure (SOP) Development
• Sterile Procedures
• Strategic Thinking

Nice To Haves

• Experience with sterile GMP facility startup.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

Responsibilities

• process tech transfer
• scale-up activities
• quality investigations
• change management
• technical operations support
• authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees