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 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’ Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities.
Once the facility is operational, this role will support the pipeline’s most technically complex formulations 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 collaborate closely 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. 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 Device Development (PSDD).
Education Minimum Requirements:
- Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience
- Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field.
Required Experience and Skills:
- Excellent enterprise leadership skill demonstration
- Excellent interpersonal and communication skills, both verbal and written.
- 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 operations.
- Knowledge of Investigational drug regulatory requirements.
- Understanding of Clinical Supply Chain Operations.
- Expertise in drug product aseptic processing, equipment, and sterile technique.
Required Skills:
- Change Management
- Chemical Engineering
- Clinical Trials Operations
- Engineering Processes
- GMP Compliance
- Leadership
- Medical Supply Management
- Medicinal Chemistry
- Process Simulation
- Standard Operating Procedure (SOP) Development
- Sterile Procedures
- Willingness to Learn
Preferred Skills:
- Aseptic Processing
- Aseptic Processing
- Business Readiness
- Clinical Supplies Management
- Clinical Supply Chain
- Communication
- Drug Product Development
- Experimentation
- Group Problem Solving
- Knowledge Process Outsourcing
- Laboratory Testing
- Manufacturing
- Manufacturing Engineering
- Organizational Behavior
- Organizational Change Management
- Organizing
- Petroleum Engineering
- Pharmaceutical Sciences
- Process Consulting
- Process Development (PD)
- Process Engineering
- Process Technologies
- Product Development
- Product Engineering
- Project Commissioning
- {+ 10 more}
