Job Listings

The HR Coordinator will act as the first point of contact for HR-related inquiries from employees. The main administrative duties include maintaining employee records, managing HR documents, and updating internal databases. This role will also play a pivotal role in driving our recruitment efforts through innovative and effective social media strategies. This individual will leverage their expertise in social media platforms, analytics and candidate engagement to attract top talent and build a strong employer brand.

Quality Assurance Inspectors work “hands-on” on the production floor, inspecting packaging, labeling and finished products to ensure products comply with Company policies and standard operating procedures (SOPs) and Good Manufacturing Practices (GMP) requirements. Quality Assurance Inspectors are responsible for sampling, inspection and physical testing of packaging components. Quality assurance Inspectors ensure procedures and documentation meet cGMP and Quality standards. As a key support member of a rapidly growing company, the QA Inspector must be flexible in their approach to work and be comfortable with taking on new challenges.     The ability to...

3 to 5 years’ experience with designing processes and equipment for pharmaceutical manufacturing. Experience in aseptic filling is a plus. Serve as the technical subject matter expert for filling or packaging equipment. Responsible for the overall maintenance and reliability of automated manufacturing lines and help troubleshoot equipment issues in a fast-paced environment. Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering.

This position supports Equipment and Sterilization Validation processes, including Autoclave, SIP, tunnel, dry heat, and VHP studies, for commercial and new R&D drug development activities at the Lakewood, NJ plant. The role involves assisting with generating, reviewing, and approving protocols, deviations, and reports, as well as scheduling activities and providing feedback to internal and external customers. The individual will support qualification activities related to Process Performance Qualifications (PPQs) and ensure compliance with FDA and international regulations.

This Cleaning Validation Associate will support the Cleaning Validation program, including equipment processes and procedures for commercial and new R&D drug development activities at the Lakewood, NJ plant. The role involves assisting in the generation, review, and approval of protocols, deviations, and reports; scheduling manpower activities; and providing feedback to both internal and external customers. The associate will help manage Cleaning Validation activities, including Development, Verifications, Validations, and Monitoring, under the guidance of a senior specialist. Regular interaction with regulatory and compliance personnel is expected to ensure adherence to FDA and international regulations. The associate will also assist in representing...

The Forklift Operator reports to the warehouse management and is responsible for various duties in maintaining warehouse, shipping, and receiving areas.

The Scientist I, QC Analytical will apply basic knowledge of principles/theories and concepts to develop solutions to technical problems of limited scope and to perform basic tests and analysis in the Quality Control Analytical Chemistry Laboratory.  This role will conduct laboratory procedures in compliance with established protocols while keeping appropriate records, providing information to other departments/clients.   Hours for this position are Monday - Friday, 3:00 pm - 11:30 pm

The Scientist II, QC Analytical identifies basic technical problems, atypical results or methodology malfunctions and assists in the investigation to correct them. This role provides technical support for routine testing activities and conducts physical and chemical analyses of samples, products and materials. This role ensures notebooks and reports are in compliance with regulatory guidelines, completes projects within time limits and budgetary constraints, performing mathematical calculations, interprets results, records observations and responds to and assists in audits and investigations. The role is primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. The incumbent will provide...

The purpose of this position is to plan, manage, and execute engineering and technical projects from initiation to commercialization.   The size and scope of the projects assigned are large and complex, and usually consist of high-profile equipment and process implementations that support development and/or launch activities. The Sr. Project Engineer will own and lead the management of engineering capital related activities in a cGMP environment including planning, organizing, and controlling all elements of the project. Projects include but are not limited to cGMP manufacturing suite design and construction, facility utility and support systems,...

The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.

The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.

The Automated Operator is a high-level machine operator capable of operating automated equipment. This role carries additional responsibilities than of its junior role, Operator 1, but will not require personnel to operate within sterile areas as do the Gown Qualified Operators. The Automated Operator is directly responsible for their assigned machine, including preparing for production, production efficiency, and closeout of production. This role is also responsible for documentation, escalation of issues, and coaching and directing personnel supporting their assigned machine.

The Facilities Maintence Mechanic will demonstrate a high level of Facility Maintenance ability and critical thinking skills, and aptitude for solving complex problems while demanding integrity, sense of urgency, accountability and attention to detail. This role will be on a 12-hour day shift.

The purpose of MST Scientist II position is to support the Company in the development and optimization of manufacturing processes, improving them and increasing the scale.  The ultimate goal is to develop processes that optimize the product yield and minimize the cost of production.  These products include injectables and nasal/sublingual sprays

The purpose of the Scientist II, Microbiology is to test and report cGMP test results for the Quality Control Microbiology Laboratory.  This role also provides training and support for less experienced members of the laboratory. Shift: 1st shift, Sunday-Thursday

The purpose of this role is to support validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects.  The incumbent will apply a working knowledge of method validation theories, practices and concepts while working under the direct supervision of senior R&D scientists to execute validation activities.  This role will ensure standard operating procedures and protocols are maintained and applied.

The Compounder I is an entry level position to Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures.  This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use.   Perform Clean-In-place (CIP) and Steam-In-Place...

The Process Supervisor supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety.   Hours are Sunday - Thursday 11:00 pm - 7:30 am

Primary Responsibility  for execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1.  

The Operational Excellence Quality Engineer II will be responsible for driving business transformation through the implementation of Operational Excellence tools and culture.