Associate Director, Engineering (Onsite)

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 Technical Operations – Engineering Lead is responsible for leading the equipment engineering team and providing technical leadership across aseptic manufacturing operations at the FLEx Sterile Rahway site. This role is a facility-facing technical leader, independent of product, and focuses on ensuring consistent and reliable production across programs on our aseptic formulation, sterile filling/lyophilization, sterile supply, and visual inspection processes. This role also owns process knowledge, oversight of process improvements, and compliance-critical technical deliverables. The leader will partner closely with Manufacturing, Quality, Development, and external partners to enable reliable supply, qualification of equipment and materials, and continuous improvement of sterile drug product processes.

Off-shift (2nd) work and overtime 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). 

Key Responsibilities:

• Monitor and improve manufacturing processes, including data and reports supporting regulatory compliance of drug products as they are processed through formulation and aseptic fill/finish.

• Define and direct staff activities to plan, execute, and document experiments, studies, and manufacturing processes that qualify key equipment, raw materials, and processes for clinical and commercial production.

• Build and maintain a high-performing staff of engineers to support ongoing production and process transfers.

• Serve as a key scientific and technical representative for process-related issues at internal sites and with external partners.

• Partner with Manufacturing to meet production schedules, ensure commercial supply, and uphold quality standards.

• Perform trending and monitoring of critical attributes to maintain equipment health and control process drift.

• Identify and implement process improvements in collaboration with manufacturing operations.

• Review and provide feedback on project deliverables and offer technical/scientific support (e.g., remediation initiatives, reports).

• Lead investigations with Manufacturing, Quality, and other business units to determine root causes for variations, implement solutions, and ensure corrective actions are effective.

• Collaborate with other departments on manufacturing-related issues to resolve problems and support organizational goals.

• Own the process, plan to avoid delays, and lead activities to ensure a robust and effective product and manufacturing process.

• Perform other related duties as assigned.

Education Minimum Requirements: 

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years relevant experience

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

• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years of relevant experience.

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.

• Lean Six Sigma Experience

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

• Experience with quality systems.

• Excellent organizational skills.

• Desire and w