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Formulation Manager

Company: Plastikon Industries Inc
Location: Lawrence
Posted on: February 16, 2020

Job Description:

Formulation Manager DUTIES & RESPONSIBILITIES: The Formulation Manager is responsible for medical device solutions and pharmaceutical solution preparation in a cGMP environment.--The Formulation Manager supervises formulation associates, providing leadership and review of formulation processes, environmental processes and cleaning.--Additional duties include maintaining system control, including scheduling maintenance of the area, and also assists in sourcing for process improvement.--The Formulation Manager works with R&D and Validation to provide continuous improvement within a validated system, and to scale up batches from R&D/Engineering.--The Formulation Manager reports directly to the Healthcare Business Unit Director or Plant Manager. . Job Roles required of the position: Formulation: --Develops new formulas, assists in the transfer of formulas, and generates stability protocols and data to support expiration dating on products.Product Realization/Planning: --Reviews production schedule and coordinates with management, assigning personnel to meet schedule demands.--Maintains formulation inventory system for accountability of ingredients.Lab Tech, and Clean/Sanitization of Manufacturing: --Performs wet chemistry testing such as pH, TOC and Conductivity, and performs various activities in support of these job roles, develops methods, and works with lab team to ensure compliance to procedures.--Assumes accountability for work performed.--Reviews and approves data for compliance.--Generates reports in support of the Quality System, as required.--Provides chemical related safety support to the safety officer and handles waste stream related to chemical waste.Facility Maintenance:--Performs this job role in support of formulation area equipment and assumes accountability for the work performed.--Actively review reports and documents for compliance to requirements.--Validation:--Supports validation activities in formulation.--Purchasing:--Uses the purchasing system to procure supplies for the formulation area.DCR System:--Actively uses the DCR System to generate or revise document, as needed.--CIMP System:--Provides support for continuous improvement and Kaizen events and projects.NCR System:--Supports the nonconformance system through reporting of Nonconformances and supporting Quality in investigation activities.--Provides reports and communication based on investigation findingsOther duties as assigned----EDUCATION / EXPERIENCE: Minimum Requirements:--BS/MS in science major or extensive equivalent experience, 5+ years formulation experience and 2+ years chemistry experience in a pharmaceutical, medical device facility, or research facility/university.--Education and experience in chemical interactions, specific to understanding formulation requirements.--Experience in ISO standard execution, cGMP and Quality Systems.--Skills/Qualifications: Wet-chemistry, HPLC Instrumentation, method development, calibration and lab equipment maintenance.--Skills in a variety of analytical instrumentation preferred.

Keywords: Plastikon Industries Inc, Lawrence , Formulation Manager, Executive , Lawrence, Kansas

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