Senior Specialist, Process Engineering

Job Description

Job Description:

The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Sterile Process Engineer role at the Senior Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing the completion of its’ Performance Qualification and Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility, concluding startup and operational readiness activities.

Once the facility is operational, this role will support the pipeline’s most technically complex formulation and process development through process tech transfer, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will leverage leadership skills in strategic planning and business savviness as they collaborate with the formulation scientists, engineers, operations staff, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company's pipeline. Leadership of tech transfer of these processes to the operations group will require the individual to leverage Decision Making and Execution Excellence skills to be successful. Off-shift (2nd) work will intermittently be expected as a part of the role to support operations areas. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Clinical Supply (PSCS). 

Education Minimum Requirements: 

• Bachelor’s degree 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 of relevant experience, or a

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

Required Experience and Skills:

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

• Expertise in drug product aseptic processing, equipment, and sterile technique.

• Experience in leading quality investigations and change management.

• Familiarity with United States and European Union GMP and Safety compliance regulations.

• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.

• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.

• Experience with quality systems.

• Excellent organizational skills.

• Desire and willingness to learn, contribute and lead.

• Track-record of independent problem-solving.

Preferred Experience and Skills:

• Experience with sterile GMP facility startup.

• Knowledge of Investigational drug regulatory requirements.

• Understanding of Clinical Supply Chain Operations.

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