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

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 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.

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.

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

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 …