Lyophilization Manufacturing Manager

To be considered for this position please complete the following application: Lyophilization Manufacturing Lead 

SUMMARY:

We are seeking a Lyophilization Manufacturing Lead to become an immediate and valuable contributor to the Manufacturing team. The Manufacturing Lead is integral to the production of our novel shelf stable nucleic acid assays and will be accountable for maintaing the lyophilization facility and in-house manufacture from reagent acquisition through QC of products, under a quality system compliant for regulated markets.

RESPONSIBILITIES: 

– Manage Biomeme’s newly installed lyophilization facility including:

    – Material acquisition and inventory

    – Receiving inspection

    – Reagent preparation

    – Lyophilization process and troubleshooting

    – Quality control of product

    – Implementation and enforcement of our quality management system 

    – Hiring and supervision of staff for sub-roles

    – Oversight of facility and equipment maintenance and calibration 

– Project management 

– Implementation of new products and processes

– Delivery of lyophilizaed product on-time within budget 

– Creation of SOP’s and other documents in support of our quality management system (ISO 13485) 

– Ensuring compliance to the companies quality management system and standards 

REQUIREMENTS:

– Minimum of 5 years of professional experience

– Strong experience in reagent manufacturing for pharmaceutical, diagnostics, or life sciences 

– Knowledge and experience of GMP and manufacturing regulatory requirements

– Knowledge of basic biochemistry and molecular biology concepts 

– Working knowledge of standard laboratory biochemicals and molecular biological reagents 

– Knowledge of ISO 13485 or 21 CFR quality standards

– Management experience of personnel 

– Experience in lyophilization concepts and techniques 

– Knowledge of regulatory requirements for diagnostic assays

– 10 years’ professional experience 

SKILLS:

– Excellent attention to detail

– Strong organizational abilities 

– Great communicator 

– Friendly, articulate and interested in working in a fun, fast-paced small company 

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