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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 responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and have the ability to move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Ability to travel via car, train and/or airplane to domestic and international locations as needed.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position.

Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

SELECTION GUIDELINES

Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.

DISCLAIMER

The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

The job description does not constitute and employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.