Manufacturing Supervisor, Downstream

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SUMMARY DESCRIPTION
The Manufacturing Supervisor, Downstream, will be responsible for supervising the Downstream process operations. The Downstream operations focus on dry processing of biologically derived material, including, but not limited to, cutting of devices, sterilization and packaging. Complete work in a timely manner and perform all tasks with emphasis on safety. Work collaboratively with Manufacturing, Engineering, Quality Assurance, and other functional experts to support all daily operational activities. Consult with management to resolve quality, production, and efficiency problems. Function in conjunction with manager and functional experts on special department projects. Work with internal departments to ensure implementation, maintenance, and improvement of the quality management system. Perform the essential duties and responsibilities as listed in the section below.

SHIFT SCHEDULE
Monday-Friday, 8hrs, 6:00AM-2:30PM.  Potentially moving to a two-shift operation in 2026.

LOCATION NOTIFICATION
Role is for a brand-new manufacturing facility in Braintree, MA

SUPERVISION RECEIVED
Reports to the Director, Manufacturing Operations. 

SUPERVISION EXERCISED
This position has direct supervisory responsibilities of Downstream Process Operators.

ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Primary responsibilities are to:
•    Provide direction and guidance to Operators to ensure timely execution of the production plan.  Set and manage performance targets for direct reports. Attract, develop, engage, and retain high-performing team members
•    Support production activities taking place in a cleanroom environment, requiring gowning and ungowning
•    Cross functional communication, both written and verbal
•    Coordinate with QC on inspection activities
•    Use of various computer databases, including extensive use of Oracle database for inventory management and recording of in-process manufacturing data
•    Effectively follow SOPs and policies, including compliance to cGMP/ISO systems
•    Assist in updating SOPs and putting new processes in place
•    Maintain a clean and orderly work environment
•    Manage inventory levels. Participate in cycle count activities as needed.
•    Provide support during audits. 
•    Prepare shipments for sub-contract operations
•    Review process documentation for accuracy and completeness
•    Adherence to production schedule
•    Operate process and inspection equipment
•    Some lifting up to 25 pounds is required
•    Identify, implement, and maintain LEAN initiatives
•    Train employees
•    Other duties as required

DESIRED MINIMUM QUALIFICATIONS
•    Education: High School Diploma or equivalent 

•    Experience: 3 – 5 years’ experience in manufacturing of medical devices, pharmaceuticals, and/or another regulated environment in a Supervisor role, with a team of direct reports.

Skills:
•    Excellent written and verbal communication skills
•    Strong interpersonal skills and ability to work with others in a positive and collaborative manner
•    Organizational skills
•    People leadership skills
•    Moderate computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations. 
•    Detail oriented
•    Ability to follow instructions precisely, recognize deviations, and recommend corrective actions
•    Technical competency to understand product and process
 

TOOLS AND EQUIPMENT USED
This role routinely uses standard office equipment (i.e. computers, phones, photocopiers, filing cabinets, as well as, other general office equipment). Computer skills including demonstrated proficiency with computer office application software. 

PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibi