Harrow Verified

Pharmaceuticals, Biotechnology, Healthcare

Production Downstream Lead

Ledgewood, NJOnsiteFull TimeLeadPosted 3 days agoVisa sponsorship available

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Required skills

pharmaceutical manufacturing
medical device
sterile environment
cGMP
production batch records
production schedule
labeling
packaging
quality
safety

Role summary

The Production Downstream Lead oversees Labeling/Packaging Production operations, ensuring adherence to cGMP, quality standards, and production schedules. This role involves troubleshooting, training, managing production schedules and metrics, and supporting continuous improvement initiatives. The Lead acts as a liaison for manufacturing technical questions and problem-solving, collaborating with management and other departments to achieve daily output goals and maintain a safe work environment. A minimum of 1-3 years of experience in pharmaceutical or medical device manufacturing is required.

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow’s values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you’re the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow’s ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM

A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®

A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM

A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA®

A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Position Summary

The Production Downstream Lead directly leads the activities of the Operations in the Labeling/Packaging Production areas and serves as a first point of contact for manufacturing technical questions as well as trouble shooting and escalating matters to the Supervisor. The Production Downstream Lead ensures inspection, packaging, and labeling jobs have properly trained people. Also ensure procedures are executed accurately with the highest quality. The Production Downstream Lead helps ensure the production department meets applicable cGMP requirements and completes work on time per the production schedule.

Core Responsibilities

Ensure production employees are adhering to ImprimisRx manufacturing standards and specifications.

Must be able to review and advise on production batch records.

Work with management to monitor operations throughout the shift, making the necessary adjustments in assignments to assure that the daily volume output Is achieved.

Be trained and work into labeling and packaging rotation if required.

Ensure that production schedule Is met by distributing workload in accordance with changing priorities by working in collaboration with Production Supervisors.

Manage both physical board schedule and electronic schedules up to date for planning purposes across interdepartmental use.

Ensure Interdepartmental spreadsheet is up to date with status of production per lot.

Maintain metrics for labeling and packaging departments.

Work with management to train new employees,

Provide production management feedback for continuous Improvement.

Support the Company’s safety program to maximize safety awareness and provide a safe work environment.

Assist In Evaluating /solving production problems by reviewing the area of concerns, developing potential solutions and recommendations for management.

Supports continuous improvement by Identifying potential issues and driving to Improve work processes and procedures relative to manufacturing and/or filling and packaging equipment.

Collaborate with Visual Inspection Department to assure continuity of vials being processed accordingly post inspection.

Other additional duties as assigned.

Qualifications & Requirements

High School diploma required; advanced degree preferred.

Minimum of 1 -3 years’ experience in a pharmaceutical manufacturing or medical device preferably In sterile environment.

Ability and willingness to work and participate effectively in a team environment.

Attention to detail, safety, quality and departmental requirements.

Ability to effectively communicate verbally and in writing to subordinates, peers and management.

Ability to read information and apply what Is described in the reading material to situations that may contain several details or describe processes involving several steps.

Demonstrate high level of personal motivation and initiative.

Position Type

On site

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