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

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.

The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Specialist – Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to 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 GxP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations.

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

• Foster culture of collaboration, learning and innovation.

Required Experience and Skills:

• Experience executing GxP manufacturing in pilot plant environment.

• Experience of interest in supporting electronic batch records and MES systems.

• Knowledge and experience of drug product processing.

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

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

Education Minimum Requirements:

• Associate’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 4 years relevant experience

• Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years relevant experience

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

Preferred Experience and Skills:

• Knowledge of Investigational drug regulatory requirements

• Understanding of Clinical Supply Chain Operations

• Experience with Commissioning, Qualification and Validation

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

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical …