Supervisor Manufacturing

Job Title: Supervisor Manufacturing

• Location: Framingham, MA

About the Job

Position in a new large scale cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations. Initial job responsibilities will include performing a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and Product Change Over.

The primary job function post PV runs will be Support Operations. Responsibilities will also include supporting Upstream and Downstream Operations as necessary. The Manufacturing Supervisor will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

Main Responsibilities

• Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of supervisory and specialized skills.
• Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
• Coach and mentor staff in all aspects of their job performance and career development including training, feedback, rewards, and disciplinary action.
• Develop work plans, assign tasks, and supervise a large team or multiple small teams
• Implement and administer policies and procedures that typically affect individual subordinate employees.
• Establish key performance indicators, maintain, and report applicable department or organizational metrics.
• Represent business unit in Project team meetings related to global initiatives.
• Interact with project teams and research groups as they impact the quality operation.
• Perform internal audits of the SOPs and documentation related to QS Enterprise Systems and other functions that receive CQO QA oversight.
• Lead and implement continuous improvement projects.
• Ensure projects are completed on schedule.

Additional Responsibilities

• Ensure execution of manufacturing activities in strict accordance with production batch records, standard operation procedures, and cGMP.
• Maintains a safe working environment and reporting of incidents/accidents to Site Leadership.
• Implement and maintain production schedules.
• Ensure manufacturing personnel are trained to perform all assigned functions and tasks.
• Partner with Manufacturing Managers and Quality to ensure manufacturing areas are inspection ready at all times.
• Ensure manufacturing personnel are compliant with annual safety and cGMP training.
• Operate complex systems and equipment in accordance with production batch records, SOPs, and cGMP.
• Utilize documentation control systems to author, review, and improve documentation
• Utilize process knowledge and investigation skill set to identify and resolve departmental issues.
• Escalate production floor issues related to procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing Management and/or appropriate functional area(s).
• Adhere to site scheduling processes.
• Ensure personnel identify and document events that deviate from procedure.

About You

Basic Qualifications

• High School Diploma/GED with 5-10 years of experience in a cGXP environment or a bachelor's degree with 4-8 years' experience.
• 1 year in a lead or supervisor role.
• Must have prior experience in cGMP manufacturing operations.
• Demonstrated ability to effectively coach and train employees.
• Ability to lift up to 50 pounds.

The salary range for this position is:
$90,000.00 - $130,000.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.