Our client, a leading Life Sciences company, is hiring a Production Manager.

Work Location: Middlesex County, Massachusetts

Summary:

• Lead the production of GMP needs (per production plan) within the USDA Outlines of Production and Special Outlines, and European Regulatory Dossier specifications, according to established procedures.
• Supervise the daily operations of the antigen manufacturing support group team to ensure completion of all assigned tasks, each of whom will be a direct report.
• Maintain current, accurate data trending.
• Supervise numerous direct reports, including assignment of goals and completion of annual performance reviews in Workday.
• Review manufacturing batch records.
• Maintain inventory of all required lab supplies and raw materials required for P45 and adjuvant production.
• Train new technician(s) as required in all manufacturing techniques.
• Organize the preventative maintenance and analytical systems.
• Oversee and document training of New Hires.
• Cover any and all manufacturing positions in event of employee absence, resignation, termination or other unforeseen event if required.
• Comply with all Standard Operating Procedures, Manufacturing Control Procedures, cGMP’s, Safety Policies, attendance policy, and code of conduct.

Secondary Functions:

• Review of any and all completed logs for equipment clean and use, temperature monitoring, differential pressure monitoring, etc. within the manufacturing areas.

Qualifications:

• Must have an in-depth knowledge of biologics production within a recombinant bacterial biotech manufacturing company.
• Must have knowledge of all applicable regulatory guidelines relating to the manufacture, quality control and quality assurance of veterinary biological products.
• Must have strong communication, leadership and organizational skills.
• Must read, write, speak and comprehend English.
• Must be able to stand, walk, lift, and perform repetitive tasks.
• Must be able to use computers competently and be able to use typical applications such as spreadsheets, word processing, and graphing efficiently.
• Must work independently.
• Must be able to recommend/select appropriate techniques for problem solving and exercise judgment and make decisions based on data analysis.
• Must understand the fundamentals of experimental design and use of proper controls. Must be able to organize and prioritize personal and company activities.
• Bachelor degree in Biology, Biotechnology certificate, or AS or BS degree in a scientific discipline with more than 4 years relevant experience in a cGMP biopharmaceutical manufacturing environment.
• Must possess superior work ethic and demonstrate exceptional attention to detail, and have solid interpersonal relationship skills.

Published Category: Manufacturing & Technical Operations