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Manufacturing Superintendent Manager

Hanna Resource Group

This is a Full-time position in Lexington, KY posted May 6, 2021.

We are looking for a Manufacturing Superintendent to join our team!

 

Summit Biosciences is a fast growing a fast-growing leader in the field of Intranasal Pharmaceuticals.

At Summit Biosciences, we aim to provide and promote an environment of continuous learning and improvement, which leads to and harnesses innovation.

 

We offer fantastic perks & benefits such as strong compensation w/ bonus program, medical/dental/vision/life/disability insurance, 401k + company match, holidays off, PTO, a family like culture, and much more!

 

Responsible for leading the Manufacturing team in the manufacture of nasal spray drug products. Lead Manufacturing Team in a multiple shift operation through shift leads and associated manufacturing staff to achieve all required activities in safe, high quality and time appropriate manner. Responsible for developing and executing a manufacturing schedule in conjunction with other Summit Departments.

 

Essential Duties:
Work in a safe manner in accordance with site procedures.

Lead Manufacturing team in following Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during manufacture.

Lead Manufacturing team in following SOPs to clean, sanitize and prepare process equipment and rooms for manufacturing.

Maintain areas and manufacturing documentation in compliance with SOPs and cGMPs.

Set the pace of the process operation to ensure work is performed in a consistent manner while maintaining high safety and quality standards.

Deliver results for safety, quality, waste reduction, and operational excellence.

Complete PBRs, Logbooks, Forms, and other documentation.

Lead training of other manufacturing team members on safety, PBRs, SOPs, and cGMPs.

Lead team in maintaining all manufacturing areas in an audit ready state using principles of 5S.

Utilize visual metrics to drive continuous improvement of KPIs.

Assist in compilation and review of lot records prior to submission to QA.

Write and review SOPs and Forms to accurately reflect the current procedures.

Maintain an inventory of supplies necessary for manufacturing.

Lead investigations to resolve incidents and deviations.

Coordinate manufacturing, calibration, and maintenance activities with other departments.

Execute and review validation protocols for manufacturing support equipment.

Independently champion manufacturing or facility related improvement projects, continuous improvements, or cost savings opportunities.

Continuously coach team members by providing developmental feedback.

Participate in administrative tasks such as timecard approval, budgeting, recruiting, and performance reviews.

Other duties as assigned.

 

Knowledge, Skills and Abilities:
Experience in a cGMP manufacturing environment.

Enthusiasm for working in teams and collaborating with internal colleagues.

Excellent written and verbal communication skills.

Excellent organizational skills and attention to detail.

Excellent working knowledge of cGMPs, OSHA compliance, HVAC systems and cleanrooms, and pharmaceutical processing and plant equipment.

Outstanding capability to be flexible, adaptable and self-motivated in response to changing conditions and schedules.

Exceptional leadership and interpersonal skills and the ability to work well in a team environment.

Develops strong relationships and leads team to achieve results.

Demonstrates self-control to others when dealing with stressful situations.

Enthusiasm for building a company with outstanding work ethic; must be able to excel in a fast-paced, multiproduct environment/ Experience with Microsoft Word, PowerPoint, and Excel/
 

Qualifications:
BS in engineering or related life science.

Preferred 5 years of applicable experience working in a pharmaceutical manufacturing environment including hands-on manufacturing experience and leadership experience.

Qualified to work with controlled substances.