Senior Specialist, Process Engineer

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 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.

• Author and review 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 7 years relevant experience

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

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience

• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field

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

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 separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please underst