Sr. Specialist, Process Engineering - 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.  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 a Sr. 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 in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.

• Author and review GxP documentation including but not limited to 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 with relevant partners, 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.

• Identifies and resolves 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.

• Foster culture of collaboration, learning and innovation.

• Support in setting specific and measurable short- and long-term goals.

Required Experience and Skills:

• Proven ability to identify and develop innovative ideas.

• Strong problem-solving skills and a direct involvement approach to problem solving | Candidate should be able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and 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.

Education Minimum Requirements:

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

Preferred Experience and Skills:

• Pharmaceutical development experience.

• Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development, optimization and execution of novel production technologies.

• Experience with small molecule drug product manufacturing technologies, including: blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion.

• Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector.

• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.

• Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solving practical pharmaceutical development problems.

• Hands-on experience in pharmaceutical manufacturing plants.

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float betw