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19 days old

Manufacturing Supervisor

Kelly Services
Long Island City, NY 11101
**Manufacturing Supervisor**


**Salary 120k**


**Direct hire opportunity**


**Location: Queens, NY**


The **Manufacturing Supervisor** will be responsible for the performance of manufacturing and materials processing and general testing for development, pilot, and cGMP aseptic manufacturing in accordance with well-defined standards and procedures. This individual will be expected to be an active resource for the team on the floor in a generalist capacity and assist in creating a positive work environment. This individual may also provide support to other groups such as Quality Control, Quality Assurance, and Research.


This position will support both Operations and Development and work closely with other key stakeholders including Quality to perform and document manufacturing processes, support cGMP facility operations and upkeep and maintain cGMP compliance.


**10 years of experience in aseptic cGMP biopharmaceutical manufacturing is required.** The Technician will be trained in bioprocessing procedures, and how to use and interpret analytical equipment and results.


**Responsibilities:**


+ Supervise an MFG team of 6-10 personnel ensuring all training is adequate and up to date. Conduct regular 1-1s and annual reviews of the staff, focusing on departmental needs and individual development, training and coaching, performance management, and recognition.

+ Schedule clinical MFG tasks across 4 different processes. Focus on staff assignments and floor needs. Manage the execution of production and resource schedules as they relate to company deadlines/timelines.

+ Cooperate cross-functionally with other groups (R&D, QA, Eng, etc) in supporting R&D programs where possible

+ Perform monitoring of facility, equipment, and utilities to ensure uninterrupted operations.

+ Ensure clear, documentation of all activities in accordance with current Good Manufacturing Practices to comply with regulatory requirements.

+ Review batch records in a timely fashion and closely collaborate with staff on documentation improvements. Confirm proper documented execution of all floor activities through MBRs, Logs, and Forms

+ Identify any issues and escalate to leadership and Quality Assurance. Work with leadership and team to address issues in a timely fashion.

+ Support the ordering, handling, labeling, and documentation of raw materials used for the manufacturing of internal products.

+ Provide support for manufacturing facility development, buildout, commissioning, and qualification activities.

+ Maintain the laboratory in a safe, clean, and orderly manner.

+ Dispose of and work alongside chemical and biohazardous material.

+ Support and respond to after-hour alarms and/or other job critical tasks

+ Support operations and development in performing equipment calibration, certification, and qualification, as appropriate, and maintain compliance with systems.

+ Compile and present manufacturing metrics, data, reporting, and process improvements.

+ Work with the Quality organizations as necessary to help investigate any excursions, deviations, CAPAs, etc and develop appropriate corrections. Track open CAPAs/deviations and facilitate effective corrective actions and on-time closure.

+ Stay current with company SOPs, batch records and industry standards, and all applicable regulations. Own continuous improvement of MFG SOPs and batch records, reducing sources of human error wherever possible.

+ Work closely with the Qualification Engineer to ensure annual MFG equipment qualifications are performed on time and any pending issues are closely monitored until resolution.

+ Collaborate with Quality Assurance in maintaining a robust and effective Environmental Monitoring Program. Ensure all aseptic personnel remains current on gowning and aseptic qualifications.

+ Brainstorm with the Process Development group on the design of experiments for future improvements or new processes.

+ Communicate any after-hours activities to Facilities personnel ahead of time and participate on the facility/equipment alarm response team.


**Job Requirements**


+ **Mandatory: 10 years in aseptic biopharmaceutical manufacturing** (preferably in biologics/cell therapies).

+ 5 years in a cGMP environment (ideally a commercial manufacturing site)

+ 2+ years as a Supervisor or 5+ years as a Lead or Senior Technician with related training and scheduling experience

+ Bachelors degree required.

+ Attention to detail and ability to follow clear written documentation

+ Competency with Microsoft Office (Word/Excel)

+ Requires moderate levels of standing

+ Comfortable spending several hours in our aseptic cleanroom fully gowned to guide the MFG team.

+ Strong ethical foundation.

+ Aseptic manufacturing of Advanced Technology Medicinal Products experience preferred.

+ Excellent interpersonal, verbal, and written communication skills are important in this collaborative work environment. Ability to effectively present and facilitate meeting dialogue towards prepared agenda


+ Ability to build and lead a team as well as train entry-level personnel

+ Knowledgeable of the current Code of the Federal Regulations (CFR's) and Current Good Manufacturing Practices (cGMP)

+ Sufficient understanding of process, systems, and equipment to troubleshoot problems and provide solutions to senior management


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-11-08 Expires: 2021-12-09

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Manufacturing Supervisor

Kelly Services
Long Island City, NY 11101

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