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 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 and strategically plan 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, 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. Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives. Foster a culture of collaboration, learning and innovation.

Requirements

Experience in executing in GMP manufacturing facilities.
Knowledge and experience in drug product processing.
Strong problem-solving skills and a direct involvement approach to problem solving
Desire and willingness to learn and contribute through independent problem-solving.
Experience in leading and supporting quality investigations and change management.
Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years relevant experience, or a Master’s degree with 1 year of relevant experience.

Nice To Haves

Pharmaceutical development experience.
Experience with small molecule drug product manufacturing technologies, including: blending, granulation, compression, encapsulation, film coating, spray drying, and hot-melt extrusion.
Experience with Commissioning, Qualification and Validation
Experience with spray dried intermediates and/or hot melt extrusion

Responsibilities

Lead and strategically plan 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, 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.
Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
Foster a culture of collaboration, learning and innovation.