Sr. Specialist, Process Engineering - Oral Solid Dosage, Clinical Manufacturing; Onsite

The Formulation, Laboratory, and Experimentation (FLEx) Center, a multi‑modality drug product development and clinical manufacturing facility located in Rahway, New Jersey, is seeking a Senior Specialist – Process Engineer for the Non‑Sterile (Oral Solids Dosage) team. The successful candidate will lead on‑floor batch manufacturing and support scientific rigor of processes to enable the company’s pipeline flexibility and speed.

• Lead on‑floor batch manufacturing in a pilot plant while prioritizing safety and quality of clinical supplies.
• Author and review GxP documentation including batch records, specifications, equipment qualifications, change records, and deviations.
• Facilitate early process development by assisting in lab activities and providing knowledge transfer for scaling at pilot plant scale via technical reports and presentations.
• Propose new, innovative approaches for enhanced product understanding and/or process development, generate experimental designs, execute experimental plans, and interpret data.
• Support process development activities using Design of Experiments for new chemical entities or life‑cycle management opportunities.
• Identify and resolve technical and operational problems, collaborating with peers to solve issues that cross inter‑related units.
• 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.
• Support in setting specific and measurable short‑ and long‑term goals.

• Proven ability to identify and develop innovative ideas.
• Strong problem‑solving skills and a hands‑on approach to root‑cause analysis across safety, compliance, automation, equipment, process, and people.
• Demonstrated ability to independently design and execute complex experiments and analyze data.
• Familiarity with GMP and safety compliance regulations.
• Ability to work effectively with team members of diverse skill sets and backgrounds.
• Strong interpersonal and communication skills, both verbal and written.

• Pharmaceutical development experience.
• Experience with small‑molecule drug‑product manufacturing technologies (blending, granulation, compression, encapsulation, film coating, spray drying, hot‑melt extrusion).
• Experience with process modeling, simulation, and automation integration.
• Hands‑on experience in pharmaceutical manufacturing plants.
• Ability to apply principles of physical/organic chemistry, physical pharmacy, and materials science to solve practical pharmaceutical development problems.

• Bachelor of Science in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 5 years relevant experience; or a Master’s degree with 3 years of relevant experience; or a PhD with expected completion no later than June 2026.

• Work schedule may include 1st and 2nd shift; flexibility for early, late, or extended hours as required.
• Salary range: $ – $, with eligibility for annual bonus and long‑term incentive.
• Benefits: medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
• Location:
  
  Rahway, New Jersey.
• Visa sponsorship: available.
• Travel: 10 % expected.

Our company is an Equal Employment Opportunity Employer. We prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, and other legally protected characteristics.
EEOC Know Your Rights
EEOC GINA Supplement
. We encourage all applicants to apply.