Sanofi Group Sr Associate Manufacturing in Allston, Massachusetts

This is a 12hr Rotating Night Shift Position

The Upstream Operation Department performs small and large scale cell culture operations, equipment preparation, clean in place (CIP) and steam in place (SIP) of process equipment and the preparation/operation of microfiltration and chromatography systems in our Allston Landing Manufacturing Plant.

POSITION OVERVIEW/KEY RESPONSIBILTIES*:

This position is responsible for performing a variety of complex tasks under general guidance and in accordance with current GMP's.

Responsibilities include:

  • Small Scale Team

  • Demonstrating general knowledge of mammalian tissue culture processes

  • Daily monitoring of seed cultures including sampling and in process assays (cell counting)

  • Scaling up of seed culture

  • Large Scale Team

  • Demonstrating general knowledge of mammalian tissue culture processes

  • Completing tasks in support of large scale cell culture bioreactor operations

  • Daily monitoring of cultures and bioreactor processes including sampling and in process assays (cell counting)

  • All Teams

  • Demonstrating general knowledge of aseptic techniques

  • Building equipment for use in manufacturing operations including spinner flasks, sample apparatus, and kitting of equipment with strict adherence to SOPs

  • Performing CIP and SIP operations to prepare equipment for manufacturing operations.

  • Operating autoclaves and glassware washers

Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities.

  • Following accurate oral & written procedures in operating production equipment & performing processing steps

  • Maintaining orderliness of process area

  • Stocking production area with supplies

  • Monitoring operations to ensure compliance with process specifications

Leads shift in absence of a Supervisor. Routinely interacts with support groups. Understands and maintains production schedule. May recommend development opportunities for less experienced co-workers

Practices safe work habits and adheres to Genzyme’s safety procedures and guidelines.

Trains new employees.

Interacts with other support functions such as QA, QC, Mfg Engineering, MTS, Validation, etc.

May be asked to represent the organization at meetings such as shift scheduling meeting, MDI, deviation review meetings, and project meetings.

Utilizes manufacturing knowledge to improve process operations and affect positive change.

* Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs

LEADERSHIP QUALIFICATIONS: N/A if this position does not have direct reports

Sr. MFG Associates are expected to fulfill the role of Team Lead in the absence of the team supervisor. In this role they are responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings, and providing technical support as needed.

BASIC QUALIFICATIONS:

  • High School Diploma/GED with 5-7 years in cGXP manufacturing environment, or Bachelor’s degree with 3-5 years of experience.

PREFFERED QUALIFICATIONS:

  • Bachelor’s degree with 4-6 years of experience in bulk biologics cGMP manufacturing.

  • Effectively uses process automation systems to operate production processes (i.e. DeltaV).

  • Training, coaching, and leadership experience.

  • Experience reviewing and creating controlled documents.

  • Familiarity with deviation management systems (i.e. Trackwise).

  • Experience on-the-floor leadership or “subject matter expertise” in Cell Culture operations.

SPECIAL WORKING CONDITIONS: N/A

  • Ability to lift up to 40 lbs

  • Ability to stand for 6 hours in a production suite.

  • Ability to gown and gain entry to manufacturing areas

  • Ability to work a 12 hour rotating shift and every other weekend, including holidays as scheduled.

DISCLAIMER:

The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Requirements are subject to possible modification to reasonably accommodate qualified individuals with disabilities. This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.

At Sanofi, our ambition is to be an integrated global healthcare company, focused on patients’ needs. Much more than just a leading pharmaceutical company, Sanofi is committed to transforming scientific innovations into solutions and services that protect health, enhance life, and respond to the needs of the 7 billion people in the world. We trust our ambition to guide and inspire us as we work to create a future with optimal health and wellness for everyone.

Sanofi is a global healthcare leader focused on patients' needs, engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. Sanofi has core strengths in diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and Sanofi Genzyme.