Please note : Supervisor / Manager level candidates who have upstream manufacturing experience and API / drug substance, are highly preferred.
About This Role
This role leads a shift team and is responsible for manufacturing bulk drug substance. This manufacturing facility is 24 / 7 operational and the role may require to be flexible with working hours (will move to 2-2-3 fixed schedule come operations phase).
What You’ll Do
Project Phase (Through Mid-2025)
- Supports Factory Acceptance Testing (FAT) at the vendor site as required
- Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
- Performs other operational readiness tasks as required, such as : document review / approval, team onboarding, and materials management
- Supervises manufacturing associates on technical and operational topics, such as : area unit operations and equipment
- Administers company policies, such as, but not limited to : travel & expense, time reporting, and time off that directly impact employees
Operations Phase (Starting Mid-2025)
- Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
- Coordinates the execution of the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
- Fosters an inclusive, people-first culture with regular communication, conducting 1 : 1s on a defined cadence with direct reports
- Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
- Supports manufacturing investigations and continuous improvement projects
- Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to : maintenance, calibration activities and the use of manufacturing equipment
- Administers company policies, such as but not limited to : time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
- Performs other job as assigned
Who You Are
You have a high degree of knowledge and expertise of the operation of production equipment in their respective functional area.
You have an understanding of manufacturing run cadence and order of shift activities. You have expertise in cGMP, safety and FDBN operational procedures.
You have a strong cross functional partnership with Quality, Process Sciences, Process Engineering and others. You are able to create and maintain a collaborative and inclusive team.
You have the ability to travel and have a valid passport.
Basic Requirements
High School Diploma or GED with 8 years of experience from a similar role in large pharma / biotech operations or projects
Preferred Requirements
- BA / BS Degree in Life Sciences with 4+ years of experience from a similar role in large pharma / biotech operations or projects OR
- Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma / biotech operations or projects
- Military Experience in combination with large pharma / biotech operations or projects
- Experience in manufacturing of biological products, familiar with GMP / GLP requirements
- Previous experience leading, supervising or managing others
Manufacturing Supervisor
Please note: Supervisor/Manager level candidates who have upstream manufacturing experience and API/drug substance, are highly preferred. Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenan...
Quality Assurance Supervisor (Manufacturing)
At least three years of leadership or supervisory experience in quality assurance within a manufacturing environment, preferably in the door and window industry. Track and report on the progress and impact of quality issues throughout manufacturing and materials received by the warehouse department....
Manufacturing Supervisor (Production)
The Production Supervisor plays a pivotal role in fostering a culture of operational excellence, continuous improvement and precision, ensuring that every aspect of the team’s operations aligns with the company’s strategic vision. Tasked with the operational oversight of labor management, productivi...
Manufacturing Supervisor, (Inspection & Packaging) - Night
You will be a production shop floor supervisor in a Flu Vaccine manufacturing facility, managing staff in buffer and media prep operations. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccin...
Supervisor, Manufacturing Support
The Supervisor, Manufacturing Support is responsible for leading the material, training and production scheduling teams within manufacturing support and their associated activities to ensure compliant and reliable production. We are growing our locations and are investing more than $2 billion into e...
Supervisor, Manufacturing Documentation
The Supervisor of Manufacturing Documentation leadsthe manufacturing documentation and recipe driven operations team and their associated activities to ensure compliant and reliable production. We are growing our locations and are investing more than $2 billion into establishing a new large-scale ma...
2nd shift Production Manager
Accentuate Staffing is assisting an established manufacturing client of ours in the Garner area who is looking for a Production Supervisor to join their team. ...
Warehouse Operations Supervisor
Unloading of customer/inventory transfers from corporate warehouses. ...
Charter and Tours Operations Manager
Raleigh, North Carolina, is seeking a skilled and experienced Charter and Tours Operations Manager. This role requires a unique blend of expertise as a Professional Motorcoach Operator, Dispatcher and Scheduler, Sales operations, and comprehensive operational experience in the charter and tour bus i...
Site Supervisor
As a Site Supervisor you will perform a variety of cleaning tasks to keep the buildings looking perfect. Janitorial Supervisor Responsibilities:. Janitorial Supervisor Requirements:. Proven experience working as a Janitorial Supervisor. ...