Associate Specialist, Engineering; Onsite

Job Description

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting‑edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile. The FLEx Sterile facility is poised to play a pivotal role in the long‑term success of delivering our clinical pipeline to patients worldwide, encompassing a range of product modalities, including sterile small molecules, biologics, vaccines, and antibody‑drug conjugates (ADCs).

A large‑scale capital project, the FLEx Sterile Expansion project, is currently underway.

The Expansion project is nearing completion of its detailed design phase and has begun construction and commissioning of long‑lead‑time process equipment. Upon completion, the expansion will more than double the capacity of the existing facility by adding a second clinical filling/lyophilization suite, a formulation suite, a sterile supply suite, and supporting infrastructure.

At the Associate Specialist level, this role will contribute to technical transfer, manufacturing science and technology, startup and operational readiness activities, and deliverables related to the expansion. The successful candidate will collaborate closely with formulation scientists, engineers, quality representatives, and other team members to ensure the quality of the clinical supplies and the scientific rigor of the processes, enabling flexibility and speed for our pipeline.

Once the facility is operational, the role will support formulation, process development, scale‑up activities, quality investigations and change management, standard operating procedures, and protocols in support of sterile clinical drug product operations.

• Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field by May 2026

• Familiarity with United States and European Union GMP and safety compliance regulations
• Ability to prepare Standard Operating Procedures (SOP) and other current GXP documents
• Effective interpersonal and communication skills, verbal and written
• Excellent organizational skills for multitasking
• Desire and willingness to learn, contribute, and lead
• Track record of independent problem‑solving

• Ability to convert new drug product attributes and process needs into executable steps and procedures for production
• Knowledge of aseptic processing, equipment, and sterile technique
• Experience leading/supporting quality investigations and change management
• Experience with sterile GMP facility startup
• Experience with commissioning, qualification, and validation
• Knowledge of investigational drug regulatory requirements
• Understanding of clinical supply chain operations

US and Puerto Rico residents only. We are committed to inclusion and provide accommodations during the hiring process as needed.

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 legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities.

Salary range: $71,900.00 – $. The successful candidate will also be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, and other standard corporate benefits.

Hybrid work model: employees in office‑based positions in the U.S. work three days on‑site per week with Friday remote, unless business‑critical tasks require on‑site presence. This model does not apply to field‑based, manufacturing‑based, or research‑based positions, or positions where remote work cannot meet job requirements.

Travel: 10%.

Job posting end date: 02/10/2026. No relocation assistance. No visa sponsorship. Shift: 1st – Day. No hazardous material exposure. Valid driving license not required.

Requisition : R381194