Senior Specialist, Process Engineering - Oral Solid Dosage

1d1 day ago

MSD

Rahway, US · Full-time · $117,000 – $184,200

About this role

The Sr. Specialist, Process Engineering leads clinical supply manufacturing with scientific rigor at the FLEx Center in Rahway. This role ensures right-first-time manufacture of high-quality oral solid dosage drug products using advanced unit operations.

This person will lead on-the-floor batch manufacturing in a pilot plant, prioritizing safety and quality. They will author and review GxP documentation including batch records, deviations, and equipment qualifications.

The Non-Sterile Process Engineering team supports early process development by assisting in lab activities and scaling at pilot plant scale. They collaborate with formulators, engineers, and safety representatives to foster a culture of collaboration and innovation.

By leveraging pharmaceutical unit operations like spray-drying, hot-melt extrusion, and tablet compression, the specialist enables faster delivery of new medicines to clinical trials. This role offers opportunities to propose innovative approaches and apply Design of Experiments.

Requirements

Proven ability to identify and develop innovative ideas.
Strong problem-solving skills with a direct involvement approach; ability to examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to identify root cause.
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.

Responsibilities

Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.
Author and review GxP documentation including batch records, specifications, equipment qualifications, 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 via technical reports and presentations.
Propose new, innovative approaches for enhanced product understanding and/or process development; generate experimental designs, execute 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 resolve problems that cross into inter-related units.
Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety, and quality representatives.