Production Manager
at Company:
Pharmalucence, Inc.
in Job Category:
Manufacturing
posted on 7/2/08 12:00am
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Company
Pharmalucence, Inc.
Contact Name:
Human Resources
Contact Phone:
781-275-7120
Email:
hr@pharmalucence.com
Website:
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Position Summary:
Plan and schedule production activities in the aseptic manufacturing area to meet sales requirements as set by commercial operations. Manage device manufacturing and pharmaceutical packaging operations in coordination with aseptic manufacturing. Responsibilities include ordering and tracking raw materials, as well as carrying out production of pharmaceutical kits and Active Pharmaceutical Ingredients (API) according to current Good Manufacturing Practices (cGMPs). Work with engineering group to revise methods/procedures, as needed, to improve efficiency and quality of manufacturing process while ensuring proper operation of production equipment/utilities. Oversee all parenteral kit and device production. Works under limited supervision.
Responsibilities:
Plan production and delegate duties to drug and device personnel
Review batch records. Write and revise SOPs and other documents as needed in accordance with cGMPs
Order supplies in a timely fashion to assure there will be no interruption of production
Following SOPs and in accordance with cGMPs, carry out pharmaceutical manufacturing
Assure that personnel are trained per cGMP regulations for the jobs they are performing
Make recommendations and perform follow up on efficiency and cost improvements
Ensure safety of work environment for production personnel
Works with QA, reviews current operational standards for compliance with current quality guidelines.
Education and Experience Required:
. Bachelor's Degree in biology, chemistry, operations, management or medical technology
5-10 years experience with quality systems/aseptic manufacturing
2-4 years supervisory experience
Working knowledge of cGMP
Skills Required:
Strong organization skills
Supervisory skills
Communication skills (oral and technical writing)
Working with radioactive materials
Computer skills




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