Supervisor, Production Operations (2nd Shift)

Supervisor, Production Operations (2nd Shift) – Burlington, MA

Build your future at Curia, where our work has the power to save lives

The Supervisor, Production Operations will be responsible for the planning of daily manufacturing activities per the weekly production calendar. This role is also responsible for the completion of assignments needed to execute a dynamic production schedule within the clean room cGMP facility. The Supervisor will work with cross-functional departments to complete assignments in a fast-paced and dynamic environment.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer
•    Generous benefit options (eligible first day of employment) 
•    Paid training, vacation and holidays (vacation accrual begins on first day of employment)
•    Career advancement opportunities 
•    Education reimbursement
•    401K program with matching contributions
•    Learning platform
•    And more!

Supervisory responsibilities
This position does have supervisory responsibilities

Responsibilities

•    Coordinate the activities of a work team, which may consist of several Manufacturing Technicians and provide expertise for the specific technical area
•    Train and develop junior staff on aseptic technique and filling machine operation
•    Perform and train aseptic processing operations and serve as the lead operator in these activities
•    Provide leadership, in the absence of the department/shift manager
•    Work with management on team performance management, including annual reviews, disciplinary actions, training status, employee development plans, and succession planning
•    Escalate any non-conforming events to the appropriate cross-functional stake holder
•    Function independently or in a larger cross functional group
•    Plan, oversee and participate in projects as necessary based on the department needs
•    Operate, troubleshoot and maintain manufacturing equipment and see through the maintenance process using work orders
•    Ensure direct reports maintain 100% up to date on their training curricula
•    Conduct, coordinate and document quality/safety incidents and investigations, corrective and preventive actions (CAPAs)
•    May establish and maintain systems to track department deliverables and trend performance against metrics
•    Ensure the cleanroom is equipped with the necessary materials, tools and equipment necessary. Will order supplies and issue work orders as needed
•    Own, review, and approve complex manufacturing documents and records to ensure they comply with CGMPs and internal quality system requirements 
•    Work with Engineering, Materials Management, Quality Assurance and Validation to complete assignments, and ensure ongoing continuous improvement

Required

•    High School diploma or GED and a minimum of 5 years of relevant related work experience, plus 1 year in a leadership role
OR
•    AAS Degree and a minimum of 3 years of relevant related work experience, plus 1 year in a leadership role
OR
•    BA/BS Degree and a minimum of 1 year of relevant related work experience, plus 1 year in a leadership role

Preferred

•    Previous cleanroom or cGMP experience

Knowledge, skills and abilities

•    Fill/finish or aseptic technique training strongly preferred
•    Ability to become fluent in all functional areas Ability to pass sterile gowning qualification required 
•    Excellent communication skills
•    Desire to work collaboratively with clients, vendors, and supporting departments
•    Must be versatile with strong prioritization skills 
•    Ability to delegate tasks appropriately to a wide range of skilled technicians and function
•    Comprehensive understanding of cGMP compliance and proficiency with Windows-based Microsoft Office applications is a requirement

Physical requirements
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee mu