QC Expert - Microbiology

Job Title: QC Expert - Microbiology

Location: Framingham, MA

Hours: Mon-Friday 830 a.m.-5:00 p.m.

About the Job

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. 

Quality Control Microbiology supports manufacturing activities at Sanofi’s Framingham Campus by detecting, quantifying and identifying possible contaminants that may interfere with the quality of the product during the difference stages of the manufacturing process. It aims to maintain a state of microbiological control in the Utility Systems and within the environment where the manufacturing process is executed. It assesses the aseptic behavior of the personnel involved in these processes; and contributes to the guarantee

that the end product will meet the pre-defined standards for safety, purity, identity and effectiveness.

Quality Control Microbiology Scientist II develops and authors complex, explicit

documentation for new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics. Solves assay/process problems. Identifies potential problems and proactively suggests technical solutions based upon analytical expertise and knowledge of product/process. Coordinates completion of specific project tasks with other departments. Provides contributions to the understanding and

interpretation of results and how they impact the design of subsequent experiments.

Contributes to development of project strategy in consultation with supervisor and/or colleagues. Train technicians and lower level analysts.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

• Independently plans and executes projects in support of the QC Microbiology Laboratory.

• Evaluates new technologies for implementation in the QC Microbiology Laboratory.

• Uses in-depth technical knowledge to perform method validation.

• Perform comprehensive data analysis, prepare statistical analysis of results and write technical reports.

• Ensure GMP compliance of all activities performed.

• Represent QC Micro in internal and external audits as required.

• Oversee, plan and execute QC Micro qualification and re-qualification of lab equipment and campaigns supported by QC Microbiology (cGMP).

• Ensure appropriate facility support and provide technical expertise.

• Coordinate and support validation, engineering and production assignments according to schedule without compromising quality

• Specify, procure, and coordinate validation and calibration and maintenance of laboratory equipment and instrumentation.

• Review standard operating procedures; coordinate method development, alignment and validation as required.

• Maintain positive relationship and network effectively across sites and organizations.

• Provide in depth training and assist in the writing and development of training qualifications.

• Mentors and direct the work of less experienced team members.

• Provides project oversight and participate in cross-functional teams to maintain timelines established for QC Microbiology.

• Perform assays and review as required.

• Perform other additional job related duties as required.

• Practice safe work habits and adhere to Sanofi’s safety procedures and guidelines.

About You

Basic Qualifications:

• Bachelor’s degree in Life Sciences discipline and 5 years of experience in cGMP

• lab environment, or Master’s degree in Life Sciences discipline and 3 years’

• experience in cGMP lab environment.

• PhD in Life Sciences discipline and 0-3 years’ experience in cGMP lab

• environment.

• Proficient in Microsoft Office and lab based data management systems.

• Ability to present technical data.

• Ability to work independently on scientific projects.

• Familiarity with USP and global compendial regulations.

• Scientific technical writing ability including authoring and revising SOPs, validation protocols and technical reports.