• 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)

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience
• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years of relevant experience, or a
• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field
• 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 {+ 2 more}

$117,000.00 - $184,200.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits