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The position is in a dynamic, professional lab responsible for both aseptic and non–sterile manufacturing support of small molecules and biologics, and provides exciting opportunities to contribute to the development of drugs at the forefront of the industry. Among the responsibilities for the successful candidates. Responsible for the day to day operation of a GMP microbiology laboratory that supports sterile and non-sterile manufacture of clinical supplies.
An international pharmaceutical company is seeking a pharmaceutical microbiologist for an exciting position in a laboratory, supporting early and late phase clinical manufacturing. The position is in a dynamic, professional lab responsible for both aseptic and non–sterile manufacturing support of small molecules and biologics, and provides exciting opportunities to contribute to the development of drugs at the forefront of the industry.
Among the responsibilities for the successful candidates:
• Responsible for the day to day operation of a high sample load GMP pharmaceutical microbiology laboratory
• Management of a staff of 8 bacteriologists to support clinical manufacturing of parenteral and oral solid dose products
• Oversee training of the staff
• Responsible for assuring timely revision of SOP’s, and other procedural documents.
• Responsible for quality event investigations as they relate to laboratory operations as well as implementation of appropriate CAPA’s.
• Provides guidance and feedback to drug development teams and regulatory functions in responding to health authorities worldwide
• Interacts with IT groups to assure that electronic notebooks are functioning properly and to introduce new methods into the electronic notebook environment.
• Acquires, reviews and/or approves in GMP compliant manner, data related to methods development and testing of GMP and development materials.
• Supervision and training of junior personnel.
• Maintains data in electronic notebooks.
• Prepares reports for methods, validation, and technology transfer.
• Sustains up to date knowledge on applicable department and site standard practices related to GMP’s.
• Assists in purchase and implementation of new technology.
• Serves as a member of interdisciplinary departmental teams, providing scientific and operational input to development plans.
• Drafts responses and corrective actions to internal compliance questions related to their work.
- Bachelor Degree in appropriate scientific discipline with a minimum of 10 years' experience in pharmaceutical microbiology is necessary.
- A solid knowledge of GMP requirements and a history of interacting in health authority inspections, as well as a strong history of supervisory experience and good communication skills, both written and verbal, are required.
- Experience with compendial microbial test methods, isolator technologies, environmental monitoring, endotoxin testing and Lean Lab Practices. Implementation of electronic notebook technologies, and instrument qualifications in a microbiology environment are desired.
At least 10 year(s)
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