Job Title Senior Manufacturing Associate
Job Profile ID JPR_0004585
Department Senior Manufacturing Associate
Reports To (Position) Manufacturing Supervisor
Section 2: Job Description Details
The Manufacturing 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 Facility.
Position Overview with Key Responsibilities
Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
This position is responsible for performing a variety of complex tasks under general guidance
and in accordance with current GMP's.
Acting as a lead operator for the manufacturing team
Operating on a manufacturing floor in accordance with CGMP's and standard operating procedures
Performing clean in place and steam in place operations to prepare equipment for manufacturing operations and monitoring equipment to ensure process specifications are met
Using and maintaining bench top equipment properly
Assisting in the review & creation of operation documents by providing input to technical composition of document
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 Practices safe work habits and adheres to Sanofi Genzyme's safety procedures and guidelines.
Trains new employees.
Provides supervision in the absence of the Supervisor.
Interacts with other support functions such as QA, QC, Mfg Engineering, MTS, Validation, etc.
Utilize manufacturing knowledge to improve process operations and affect positive Change
Sr. MFG Associates do not have direct reports, but 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
HS Diploma/GED and 6+ years cGMP manufacturing experience or Bachelor's or Associate's
Degree with 3-5 years' experience in a CGMP manufacturing environment.
Proven on-the-floor leadership or “subject matter expertise” in cGMP manufacturing environment.
Bachelor's Degree - Life Sciences
Familiarity with Manufacturing Control Systems (i.e. DeltaV)
Training, coaching, leadership experience
Experience reviewing and creating controlled documents
Special Working Conditions
Ability to lift a minimum of 40 lbs
Ability to stand for 6 hours in a production suite
Ability to gown and gain entry to manufacturing areas
Ability to work 12 hour rotating shift and every other weekend, including holidays as Scheduled
Above information was designed to indicate the general nature and level of work performed by employees with this job description. 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 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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.