Associate Specialist, Process Engineer - 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. This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) 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.
• Master’s degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field

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

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Required Skills:

Driving Continuous Improvement, Engineering Standards, Equipment Qualification, Estimation and Planning, GMP Compliance, GMP Validation, Lean Manufacturing, Manufacturing Quality Control, Manufacturing Scale-Up, Process Control, Process Optimization, Teamwork

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$71,900.00 - $113,200.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

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