Specialist, Process Engineering - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Early Development Center (EDC) is a small molecule drug product development and clinical manufacturing facility in Rahway, New Jersey.  The EDC team ensures right-first-time manufacture and delivery of high-quality drug products (tablets, capsules, and dry powder inhalers), leveraging pharmaceutical unit operations such as blending, roller compaction, encapsulation, compression, film coating, spray drying, and hot melt extrusion. We are part of our company's research division, focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials.

 

The FLEx EDC team in Rahway is looking for a Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor of processes, to ultimately enable flexibility and speed of our company's pipeline.

 

This person will:

• Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.

• Draft and execute GMP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations.

• Facilitate and support early process development by assisting in lab activities, and sharing knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations.

• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.

• Foster a culture of collaboration, learning and innovation.

Required Experience and Skills:

• Experience in executing in GMP manufacturing facilities.

• Knowledge and experience in drug product processing.

• Strong problem-solving skills and a direct involvement approach to problem solving

• Desire and willingness to learn and contribute through independent problem-solving.

• Experience in leading and supporting quality investigations and change management.

Education Minimum Requirements:

• Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years relevant experience, or a Master’s degree with 1 year of relevant experience

Preferred Experience and Skills:

• Pharmaceutical development experience.

• Experience with small molecule drug product manufacturing technologies, including: blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion.

• Experience with Commissioning, Qualification and Validation

• Experience with spray dried intermediates and/or hot melt extrusion

#eligibleforERP

#PSCS

FLEx2026

Required Skills:

Adaptability, cGMP Guidelines, Electronic Batch Records, Laboratory Experiments, Mammalian Cell Culture, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Technical Writing, Troubleshooting

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federa