Process Engineer Scientist- Drug Product Development (Hybrid - New Brunswick, NJ)

Process Engineer Scientist- Drug Product Development (Hybrid New Brunswick, NJ)

We are seeking a Process Engineer Scientist- Drug Product Development for a global pharmaceutical client. The focus of the role is to support pharmaceutical Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

This is a 40-hour per-week, 12-month contract (extensions possible), 50% onsite role in New Brunswick, NJ. Work Schedule: Mon-Fri(normal business hours)

This is a W2 role as a Stage 4 Solutions employee. Health benefits and a 401K are offered.

Responsibilities:

• Responsible for supporting MS&T Active Pharmaceutical Ingredient (API) and Drug Product (DP) development-to-launch teams.

• Design and run experiments

• Perform risk assessments, including but not limited to Material and Process Risk assessment, Nitrosamines Risk Assessment, Elemental Impurities Risk assessment etc.

• Complete, analyze and present data analysis

• Support tech transfer activities in the form of generating test plans, change controls, executing and compiling results into reports

• Supports validation efforts in the development of validation strategies and testing plans

• Provide input into process related investigations and complete MST investigations as required.

• Advise on root-cause analysis of undesired trends or deviations related to process equipment.

• Support monitoring of studies at manufacturing areas, Contract Manufacturers, as needed

• Support the Change Control process
  
  

Requirements:

• 6+ years of Drug Product (DP) technical experience, support during experimental phase and process validation and the Pharma space for oral solids. Experience writing OSD strategies, study plans, study reports, validation protocols and reports.

• 5+ years of expertise working process related Investigations and change controls

• 4+ years of expertise in data evaluation and expertise managing Risk Assessments

• 4+ years of experience working in or supporting pharmaceutical operations

• Comfortable wearing proper PPE and working in a Laboratory -- time in Laboratory will fluctuate

• Bachelor's Degree in a Science Related field required

Please submit your resume to our network at (please apply to the Process Engineer Scientist- Drug Product Development (Hybrid New Brunswick, NJ) role).

Please feel free to forward this project opening to others who may be interested.

Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.

Compensation: $60/hr. - $65.82/hr.

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