Job Title: QC Expert (Microbiology)

Location: Framingham, MA

Shift: Mon-Fri 830am- 5pm

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.

The Quality Control team is dedicated to the development and validation of

methodologies using state-of-the-art technology and responsible for ensuring that all production lots and materials meet the required quality standards, supporting regulatory compliance, and operational excellence of the organization

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:

Providing his/her analytical expertise for any project, troubleshooting, investigation on analytical methods and lab technologies

Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans

Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, and records related to these tasks. Recording all expected raw data, calculations, and information related to his/her tasks, to comply with cGMP and data integrity requirements

Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities

Writing/reviewing and maintaining accurate analytical methods and procedures

Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately

Participating actively in any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately

Performing periodic trend analysis on method performance to determine the need to revalidate, optimize, or replace the method. Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safety status to ensure that they can be used appropriately

Supporting QC teams during internal and external audits and inspections

Key Roles:

Analysis on technical issues and troubleshooting strategies (A)

Identify priorities and propose a remediation plan on ALCM strategy (A)

Propose remediation actions from findings and CAPAs related to analytical methods (A)

Additional Accountabilities:

Ability to perform tasks in a Quality Control Laboratory environment and capable of lifting at least 10 pounds.

May be required to enter controlled environments following proper gowning protocols.

About You:

Basic Qualifications:

Bachelor's Degree in Life Sciences discipline and 9+ years' experience in a cGMP lab environment, or

Master's Degree in Life Sciences discipline and 6+ years of experience in a cGMP lab environment.

Experience in Analytical Method Development, Validation, and Transfer.

Proven project management experience

Technical expertise in several analytical platforms.

Strong and effective written and verbal communication skills.

Ability to present technical data and 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.

Experience in troubleshooting assay and equipment issues.

Working knowledge of Aseptic practices and techniques.

Preferred Qualifications:

Ability to perform laboratory work using chemicals as required

Ability to occasionally lift up to 10 lbs.

Occasional travel (< 10%) may be required to provide on-site support to Biologics QC laboratories for troubleshooting support.

Occasional nights, weekends, and holidays may be required

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is:

$84,750.00 - $122,416.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.