NTO Manufacturing Associate

Job title: NTO Manufacturing Associate

Location: Framingham, MA

Shift: 12 hrs Rotating Night Shift 7pm-7am

About the job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

Department Description:

8 NYA is an integrated, continuous, biomanufacturing facility (ICBF). The facility is operated by upstream, downstream and support services groups which support a 24/7 large-scale therapeutic protein manufacturing facility housing multiple products.

Position Overview with Key Responsibilities:

This is a 12 hour, rotating nighttime position in a flexible, single-use technology, large scale cGMP biologics facility. Initial job responsibilities will include leading a team responsible for a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV) and commercial operations.

The Manufacturing Associate will be responsible for performing a variety of complex tasks under general guidance and in accordance with the manufacturing instruction set and current GMPs.

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• Maintains a safe working environment and reporting of incidents/accidents to Manufacturing management.
• Effectively demonstrates understanding of GMPs and how they apply to specific responsibilities.
• Follows verbal and written procedures in operating production and equipment and performing processing steps; accurately completes appropriate production documentation.
• Maintains cleanliness and orderliness in process area.
• Ensures production area is stocked with supplies.
• Performs batch record review, EWI (Electronic Work Instruction) revisions, and work order generation.
• Interacts with other support functions such as Quality Assurance, Quality Control, Manufacturing Engineering, MSIT, Validation, etc.
• Utilizes manufacturing knowledge to improve process operations and affect positive change.
• Demonstrates ability to troubleshoot basic mechanical operations.
• Effectively utilizes Microsoft Office applications.
• Mentors less experienced operators.
• Fulfills the role of Team Lead in the absence of the Manufacturing Sr. Associate.
• Escalates production floor issues related to personnel, safety, procedures, materials, process, equipment, automation, utilities, and/or information systems to Manufacturing management and/or appropriate functional area(s).
• Performs in process analytical testing.
• Demonstrates general knowledge of automation systems (INFOR, MES, ERP, DeltaV).
• Demonstrates general knowledge and practice of aseptic techniques.

Additional Responsibilities:

• Cross train manufacturing personnel

• undefined Continuous Improvement Contributes to continual improvement of all manufacturing documentation (SOPs, EWI’s, MBRs, OJT’s) to ensure they are current, accurate, and clear. Supports plant floor continuous improvement initiatives.

• About you

Basic Qualifications:

• High School diploma/GED with 3-5 years of experience in a cGXP environment, or a Bachelor’s degree with 1-3 years of experience.
• Must have prior experience in cGMP manufacturing operations.

Preferred Qualifications:

• Bachelor’s degree with 2-4 years of experience in bulk biologics GMP manufacturing.
• Effectively uses process automation systems to operate production processes (i.e. Delta V).
• Familiarity with deviation management systems

Special Working Conditions:

• Ability to lift up to 50 lbs.

• Ability to stand on average 10 hours per shift.

• Ability to gown and gain entry to manufacturing areas.

• Ability to work a twelve hour rotating shift and every other weekend, including holidays as scheduled.

• 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 US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

• North America Applicants Only

The salary range for this position is:

• $27.24 - $36.32
• All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.