Sanofi Group Senior Associate Manufacturing in Framingham, Massachusetts
*12-hour rotating DAY SHIFT- 7AM-7PM- holidays and overtime as per business needs*
*Solution and Equipment Prep experience a huge plus*
*New large scale biologics facility*
The Downstream Operations Department performs purification operations (including of column chromatography, UF/DF, and nanofiltration) and cleaning of process equipment as part of a 24/7 large-scale therapeutic protein manufacturing facility.
Position Overview with Key Responsibilities
Position in a new large scale cGMP biologics facility which includes solution preparation, equipment preparation, upstream operations, and downstream operations. Initial job responsibilities will include performing a diverse range of manufacturing related activities during plant start-up from Operational Commissioning/Shakedown through process validation (PV).
The primary job function post PV runs will be Downstream Operations. Responsibilities will also include supporting Upstream and Support Operations as necessary. The Sr. 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.
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, procedures revisions, and work order generation.
Fulfills role of lead trainer on numerous operations and is an area SME.
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 team Supervisor. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings and providing technical support as needed.
May be asked to represent the organization at meetings such as shift scheduling meeting, DCM/+QDCI, deviation review meetings and project meetings.
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).
Cross train personnel from Upstream and Downstream Operations on Support Operations.
Performs in process analytical testing using pH, Conductivity, Refractometers and Osmometers.
Demonstrates general knowledge of solution preparation, equipment preparation and automation systems (INFOR, MES, ERP, DeltaV).
Demonstrates general knowledge and practice of aseptic techniques.
Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear.
Supports plant floor continuous improvement initiatives.
*Key Responsibilities may differ among employees with the same job title and may change over time, on accordance with business needs.
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures.
Being honest and treating people with respect and courtesy.
Constantly striving to make Sanofi Genzyme a great place to work, and a comany respected for the quality of its people and products.
Acting as roles models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
High School diploma/GED with 5-7 years of experience in a cGXP environment, or a Bachelor’s degree with 3-5 years of experience.
Must have prior experience in cGMP manufacturing operations.
Bachelor’s degree with 4-6 years of experience in bulk biologics GMP manufacturing.
Effectively uses process automation systems to operate production processes (i.e. DeltaV).
Extended experience in solution preparation and equipment preparation processes.
Experienced reviewing and creating controlled documents.
Familiarity with deviation management systems (i.e.Trackwise, Phenix).
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.
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.