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

Merck • Rahway, NJ

1d • Onsite

About The Position

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:

Requirements

• 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.
• 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).

Nice To Haves

• 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.

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 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.

Benefits

• 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 at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level