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The purpose of this role is to perform basic tests and analysis and conduct laboratory procedures in compliance with established protocols under supervision, while provide administrative support to ensure an efficient operation of the laboratory. This role will keep records and provide information to others. The role will maintain a level of appropriate scientific knowledge in assigned area and perform scientific literature searches and evaluations as required, while understanding and complying with accepted laboratory and safety procedures.
Hours are 3:00 pm to 11:30 pm Monday - Friday
The purpose of this 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
To review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics.
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.
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.
This position is responsible for Equipment and Sterilization Validation processes (i.e. included but not limited to Autoclave, SIP, tunnel, dry heat, and VHP studies), that supports commercial and new R&D drug development activities in support of the client projects involving all delivery systems manufactured in Lakewood, NJ plant.
This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling activities, providing internal and external customer feedback, and ensuring on-time delivery of milestone activities. The individual will be a Subject Matter Expert (SME) expected to oversee and execute the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).
This position will also interact frequently with regulatory/compliance personnel at Renaissance Lakewood LLC. It will ensure compliance to all FDA and international regulations with regard to equipment qualification and sterilization validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.
The Scientist II, Microbiology will 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: 3rd shift, Sunday-Thursday 11:00 pm - 7:30 am
The Scientist II, Microbiology will 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: 3rd shift, Sunday-Thursday 11:00 pm - 7:30 am
This position is responsible for supervising Process Maintenance activities on a daily basis with responsibility for results in terms of costs, methods, and employee management. The incumbent is responsible for the execution of the process maintenance activities and supervising the process maintenance staff to support daily production. The incumbent executes the scheduled activities and performance requirements for Process Maintenance staff to drive continuous improvement and sustainable organizational growth and acts as an advisor and mentor to direct reports to help meet schedules and/or resolve technical problems. The incumbent interfaces with internal and external stakeholders, Regulatory Compliance, QA, Operations. The incumbent will be responsible for executing the maintenance activities and ensure PM compliance to enhance asset performance. Provide technical support to the entire engineering group and cross-functional teams, as needed. In addition, the incumbent will assist in maintaining the spare parts inventory to ensure adequate stock to support production.
Ensure Standard Operating Procedures and protocols are maintained and adhere to, while ensuring that the process maintenance group remains in compliance with all regulatory and safety requirements. Support of production activities, with intimate knowledge of compounding, filling, and packaging equipment. Ensure efficient and safe operation of the Lakewood site by providing world class maintenance service in compliance with regulatory requirements. As a member of the Engineering team, participate in the successful execution of site strategy and policies.
This position is a NIGHT SHIFT position, Pittman Schedule
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.
This position is responsible for Validation activities (i.e. included but not limited to Manufacturing and packaging equipment qualification, Process validation activities, Cleaning and Sterilization validation activities), that supports commercial and new R&D drug development activities in support of Renaissance’s specific client projects involving all delivery systems manufactured in Lakewood, NJ plant.
This highly technical and highly specialized position is responsible for generating, reviewing and approving protocols, deviations and reports; as well as scheduling manpower activities, providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports. The individual will be a Subject Matter Expert (SME) expected to oversee the overall validation activities related to the support of commercial manufacturing of pharmaceutical products.
This position will also interact frequently with regulatory/compliance personnel at Renaissance. It will assure compliance to all FDA and international regulations with regard to validation activities. The employee in this role must be able to represent Renaissance with customers and senior management.
Carry out team lead / team oversight responsibilities in accordance with the organization's policies. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
This is a full-time, paid internship (40 hours/week). The full internship program period is from approximately May 2024 - September 2024.
M-F, 1st shift
Onsite Position
The Sr. Scientist leads formulation development of new pharmaceutical products through formulation optimization, product development and scale up activities. Applying a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise, independently plan, execute, and manage project(s). Provide assistance and interpretation of project results to team members and other business unit personnel. Ensure Standard Operating Procedures and protocols are maintained and applied.
The Quality Assurance Specialist will be part of the Laboratory Services Group to oversee all laboratory investigations, deviation reports, change controls from Chemistry, Micro and Spray laboratories for compliance with cGMP and company procedures with minimal supervision. The position will review changes requests related to analytical procedures and instruments qualification, review Standard Operating Procedures and analytical methods. The position will report quality metrics on laboratory investigations and perform trending of investigations.
The Janitor/Matron is responsible for keeping the building in a clean and orderly condition, in accordance with all SOPs and cGMP requirements.
Starting pay rate is $18.69/hour
12 Hour Shift 7:00 AM to 7:00 PM- Pittman Schedule
The ability to read, write and speak English is a requirement of the job.
The Sr. Automation Controls Engineer will be responsible for installing, maintaining, and troubleshooting the automation systems for automated utility, processing, filling, inspection and packaging equipment. System will be PLC, SCADA, and PC based.
Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production processby applying systems engineering principles and technology of chemistry, physics, and equipment engineering.
Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production processby applying systems engineering principles and technology of chemistry, physics, and equipment engineering.
The Operational Excellence Quality Engineer II will be responsible for driving business transformation through the implementation of Operational Excellence tools and culture.
The Continuous Improvement Production Manager is a role within Operations aimed to transform operational performance by implementing Operational Excellence tools. This individual collaborates with departments, vendors, OEMs and consultants to maximize value while eliminating waste. The Continuous Improvement Production Manager fosters a “Safety First, Quality Always” culture.
Operations’ Leaders interact directly with frontline personnel, which may include union members, and may, or may not, manage a team of direct reports depending on scope of assigned tasks.
