Associate Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)
USA - New Jersey - Rahway
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. This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company’s research division.
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Specialist – Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our company’s pipeline.
This person will:
Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
Draft and execute GxP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations.
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.
Required Experience and Skills:
Experience executing GxP manufacturing in pilot plant environment.
Experience of interest in supporting electronic batch records and MES systems.
Knowledge and experience of drug product processing.
Desire and willingness to learn and contribute through independent problem-solving.
Experience in leading and supporting quality investigations and change management.
Education Minimum Requirements:
Associate’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 3 years relevant experience
Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 1 year relevant experience
Preferred Experience and Skills:
Knowledge of Investigational drug regulatory requirements
Understanding of Clinical Supply Chain Operations
Experience with Commissioning, Qualification and Validation
Experience with spray dried intermediates and/or hot melt extrusion
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation …
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Hybrid Hybrid work Hybrid work model Onsite
Benefits/PerksBonus eligibility Diverse workplace Equal opportunity employer Flexible work arrangements Hybrid work Hybrid work model Inclusion Inclusive environment Insurance Meetings Paid holidays Retirement benefits Separation benefits package Sick Days Vacation
Tasks- Build partnerships
- Change Management
- Collaboration
- Innovation
- Validation
Biologics Business Operations Change Management Chemical Engineering Chemistry Cleaning Clinical Clinical supplies Clinical Supply Clinical supply chain Collaboration Commercial Commissioning Development Documentation Drug Product Processing Engineering Formulation GMP GxP Inclusion Innovation Laboratory Management Manufacturing MES MES Systems Partnerships Pharmaceutical Pharmaceutical Sciences Problem-solving Product Development Qualification Quality Quality Investigations Regulatory Regulatory requirements Research Safety Supply chain Talent Acquisition Validation
Experience1-3 years
EducationAssociate's Degree Bachelor's degree Business Chemical Engineering Chemistry Engineering Management Pharmaceutical Sciences Related Field Scientific field Supply Chain
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