Associate 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, leveraging pharmaceutical unit operations such as blending, roller compaction, encapsulation, compression, film coating, spray drying, and hot melt extrusion. The FLEx EDC is part of the 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.

• 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.

• 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.

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

• Knowledge of drug product processing.
• Experience with commissioning, qualification and validation.
• Experience with unit operations for solid oral dosage form manufacturing.

• Clinical Supplies Management
• Clinical Trials
• Communication
• Contractor Oversight
• Cross‑Functional Collaboration
• Driving Continuous Improvement
• Engineering Standards
• Equipment Qualification
• Estimation and Planning
• GMP Compliance
• GMP Validation
• Healthcare Procurement
• Interpersonal Communication
• Lean Manufacturing
• Manufacturing Quality Control
• Manufacturing Scale‑Up
• Pharmaceutical Processing
• Process Control
• Process Optimization
• Process Scale Up
• Product Safety
• Teamwork
• Technical Acumen
• Unit Operations
• Writing Technical Documents

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. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC website.

We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Salary range: $71,900.00 – $ (based on education, qualifications, experience, skills, geographic location, government requirements, and business needs). The successful candidate may be eligible for an annual bonus and long‑term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, other insurance benefits for employee and family, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days.

• Travel Requirements: 10%
• Shift: 1st – Day
• Job Posting End Date: 05/25/2026
• Requisition : R397681
• Employee Status:
  Regular
• Relocation:
  Domestic
• VISA Sponsorship:
  No
• Flexible Work Arrangements:
  Not Applicable
• Valid Driving License:
  No
• Hazardous Material(s): n/a
• San Francisco Residents Only:
  Will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
• Los Angeles Residents Only:
  Will consider all qualified applicants, including those with criminal histories, in a manner consistent with the City of Los Angeles Fair Chance Initiative for Hiring Ordinance.