Actively participate or lead Corporate Initiatives in support of the One2One Business Unit.
Independent execution of core microbiology activities; may be a subject matter expert for specific methodologies.
Participates independently on project teams as representative of microbiology department.
Writes and executes scientific protocols, generates data, performs technical reviews of data and writes scientific reports.
Ability to generate and analyze scientific data and handle OOS’s (Out of Specification) with minimal input from supervisor.
Coordinates drafting and technical review of reports from R&D and manufacturing Quality labs in support of regulatory submissions.
Ability to network across multiple functional groups as necessary to trouble shoot laboratory situations
Ensures strict adherence to cGMPs in all activities with the ability to coach junior microbiologists.
Maintains clean and safe work environment by adhering to aseptic methods and protocols; following standards and procedures; complying with legal regulations.
Bachelors of Science degree required in microbiology or related field.
A minimum of 3-5 years experience in microbiology and related method validations, pharmaceutical microbiology and/or supervisory experience a plus.
Knowledge of microbiological test methodologies and validation requirements (Bioburden, BET, sterility, Container Closure, etc).
Thorough knowledge and practical application of regulatory and compendial requirements, with ability to ensure compliance to standards and interpret compliance requirements for projects and laboratory activities.
Flexibility in adjusting to changing workload demands, ability to set priorities, able to support others in team environment.
Customer Service skills.
Hospira - 2 years ago
Hospira helps hospitals heal the hurting. The company makes specialty injectable pharmaceuticals (primarily generics) including...