Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
We are 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 clinical 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: Provides guidance and feedback to drug development teams and regulatory functions in responding to health authorities worldwide
• Transfers methods to development and commercial labs around the world
• Collaborates with formulation and manufacturing colleagues in order to optimize processes and improve productivity.
• Conducts testing as per assigned technique and methods.
• Documents work in laboratory notebooks and other systems and as per GMPs and department SOPs.
• Acquires, reviews and/or approves in GMP compliant manner, data related to methods development and testing of GMP and development materials. Prepares reports for methods, validation, and technology transfer.
• Sustains up to date knowledge on applicable department and site standard practices related to GMPs, safety and controlled substances as appropriate to work.
• Provides input, and may author standard practices.
• Assists in purchase and implementation of new technology
• Participates in laboratory investigations/inspections.
• Conducts Microbiology Investigations and implement CAPAs as needed
• Serves as a member of interdisciplinary development teams, providing scientific and operational input to development plans
• Drafts responses and corrective actions to internal compliance questions related to their work.
• Writes and revises SOPs, WIs and Methods as needed.
• Writes and implement change controls.
The qualified individual will have the following background
• Bachelor Degree in Microbiology or related scientific discipline with 3 to 7 years experience in pharmaceutical microbiology.
• Good communication skills, both written and verbal, are required.
• Experience with bacterial endotoxin test, bioburden and sterility, with in-depth understanding of the method, and possible interferences
• Experience with instrument qualifications in a microbiology environment is a plus.
• Knowledge of basic compendial microbial test methods is also a plus.
• Demonstrated ability to solve non-routine analytical issues and provide guidance to laboratory and external colleagues.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.