Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Position Description:

Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing

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 Director – 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 and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.

• Manage a team of 2-5 process engineers by coaching and developing for success through feedback and development guidance.

• Review and approve GxP documentation including but not limited to batch records, specification, equipment qualifications, 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.

• Support in setting specific and measurable short- and long-term goals.

Position Qualifications:

Education Minimum Requirements:

• Associate’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 12 years relevant experience

• Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 10 years relevant experience

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 8 years relevant experience

• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience

Required Experience and Skills:

• Experience leading GxP manufacturing in pilot plant environment.

• Experience reviewing and approving GxP documentation, quality investigations and change management.

• Extensive knowledge and experience of drug product processing.

• Managing and developing team including identifying and assessing goals, creating a learning environment and monitoring progress of growth.

• Familiarity with US and EU GMP and Safety compliance regulations.

• Desire and willingness to learn, contribute and lead through independent problem-solving.

• Effective interpersonal and communication skills, both verbal and written.

Preferred Experience and Skills:

• Knowledge of Investigational drug regulatory requirements

• Audit experience: safety, environmental, compliance/quality

• 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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US and Puerto Rico Residents Only:

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected v