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

Associate Specialist - Process Engineer (P1)

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. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates, tablets and capsules), leveraging pharmaceutical unit operations such as spray-drying, hot-melt extrusion, blending, roller compaction, encapsulation, compression, and film coating. 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 Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for an Associate 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 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, technical protocols, change records and deviations.
• Analyze process data to identify areas of improvement and/or build the technical know-how of the program
• Build partnerships within and across work groups of formulators, engineers, technicians, safety and quality representatives.
• Foster a culture of collaboration, learning and innovation.

Required Experience and Skills:

• Basic understanding and extensive experience visualizing and analyzing data with Excel or comparable tools.
• Desire and willingness to learn and contribute through independent problem-solving.
• Strong interpersonal, communication, and technical writing skills; ability to lead without authority and influence cross-functional teams.
• Proven root cause analysis and problem-solving skills; continuous improvement mindset.
• Strong technical writing capabilities.

Education Minimum Requirements:

• Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected completion no later than June 2026)

Preferred Experience and Skills:

• Knowledge of drug product processing.
• Experience with Commissioning, Qualification and Validation
• Experience with unit operations for solid oral dosage form manufacturing, including spray drying and hot melt extrusion

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift.

Work schedules for this role will vary based on the needs and timing of assigned campaigns. While standard working hours will apply most of the time, there may be occasions when you are required to work earlier, later, or extended hours to support campaign requirements. Reasonable notice of schedule changes will be provided whenever possible.

Salary Range: $71,900.00 - $113,200.00

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.

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee).

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully

Employee Status: Regular

Relocation: Domestic

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day, 2nd - Evening

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 03/26/2026

Requisition ID: R388864