Specialist, Process Engineering (Onsite)

About the role

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.

Responsibilities

• Lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities.
• 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.
• 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.

Requirements

• Minimum Requirements: Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience, or Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field.
• Preferred Experience: 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.

Qualifications

• 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
• Experience with quality systems
• Excellent organizational skills
• Desire and willingness to learn, contribute and lead
• Track-record of independent problem-solving

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

Pay

The salary range for this role is $87,300.00 - $137,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.