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Job: Lead Associate, Manufacturing, Seqirus, Holly Springs, NC


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General Information

(3654628)

Job title: Lead Associate, Manufacturing
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Job location: Holly Springs, NC  27540 United States
Requisition code: R-047119
Date posted: 09/06/2017
Compensation:
Job category:Manufacturing and Production
Employment type:Full time
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Job Description


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Built on 100 years of experience in influenza, Seqirus is a new global company with an exciting future. It was created in 2015 when parent company CSL Limited acquired the Novartis Influenza Vaccine business and combined it with its own longstanding influenza vaccine operations. Seqirus is currently the world’s second largest influenza vaccine company and a major partner in the prevention and control of influenza globally. It is a reliable supplier of influenza vaccine for Northern and Southern Hemisphere markets and a transcontinental partner in pandemic preparedness and response.
Seqirus operates state-of-the-art production facilities in the US, UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and commercial operations in more than 20 countries. In Australia and the Asia Pacific region, Seqirus is a leading provider of in-licensed vaccines and specialty pharmaceuticals. It also manufactures and markets diagnostics for immunhaemotology laboratories and is the sole supplier of a unique range of products made in the national interest for the Australian Government, including antivenoms and Q fever vaccine. Seqirus’ parent company CSL is a leading global biotherapeutics company with a dynamic portfolio of life-saving innovative medicines. It operates in over 30 countries with more than 16,000 employees.
Lead Associate, Manufacturing

Overview:
The incumbent will be a key shop floor leader in the manufacturing organization. The incumbent will independently provide the technical skill-sets and leadership necessary to manufacture high quality biologicals or sterile injectables safety in a compliant, efficient, and cost effective manner.
Major Accountabilities:
• Serves as a hands-on leader in Production
• Conducts all assigned activities in a safe and cGMP compliant manner. Tasks will include, but are not limited to:
o Cleaning, preparing, and sterilizing production equipment
o Cleaning and disinfecting production rooms
o Assembly, set-up, and disassembly of production equipment
o Executing process steps according to defined SOPs and BPRs
o Documenting activities and review of documentation in accordance with cGMPs
o Handling biologically and chemically hazardous goods
o Advanced understanding of process automation systems and advanced user of electronic business systems (e.g, PAS, BAS, PLCs, LIMS, SAP, LiveLink)
o Leading projects of large scope (e.g. Operational Excellence, safety)
o Authoring SOPs and BPRs
o Coordinating Qualification and Validation activities
o Coaching and training other associates to become Qualified Trainers
o Coordinating equipment and personnel resources on daily basis
o Leading resolution to quality and process disruptions cross functionally
o Recognizing issues and effectively solving major atypical process issues
o Leads the collection and tracking of area metrics and process control data
o Leads complex investigator in root cause investigations and CAPA completion for deviations
o Leads a high performance teamwork environment and champions Seqirus Values and Behaviors
o Serves as team lead, may allocate work and provide subject matter guidance to more junior team members with problem solving and teamwork
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Job Requirements


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Minimum Requirements:
• Demonstrated leader with High school diploma/GED or associate’s degree with 7+ years’ industry related experience (pharmaceutical, biotechnology, and/or sterile production environments) preferred OR bachelor’s degree with 5+ years’ industry related experience preferred OR equivalent
• Expert knowledge of cGMP requirements required
• Experience executing SOPs and documenting work required
• Advanced mechanical aptitude or knowledge of electronic / mechanical equipment
• Expert in clean room environment practices with demonstrated ability to train others
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