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A Range of Possibilities

Downstream Manufacturing Associate

date posted 09/14/2020
contract type Full time
job id R2567139
location Massachusetts; Framingham, Massachusetts

**12-hour rotating DAY SHIFT- 7AM-7PM- holidays and overtime as per business needs**

POSITION OVERVIEW

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 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. 


Core 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, procedure 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. Responsible for assignment of duties to all team members, ensuring execution of duties, communicating at daily scheduling meetings and providing technical support as needed.
  • 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 Support Operations on Downstream operations.

Additional Responsibilities:

  • Demonstrates general knowledge of purification processes and automation system (INFOR, MES, ERP, Delta V).
  • Demonstrates general knowledge and practice of aseptic techniques.
  • Operation of a spectrophotometer to obtain product concentration.
  • Performs PM and CIP operations to prepare equipment for manufacturing operations.

Continuous Improvement:

  • Contributes to continual improvement of all manufacturing documentation (SOPs MBRs, OJTs) to ensure they are current, accurate, and clear.
  • Supports plant floor continuous improvement initiatives.

Basic Qualification:

  • 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 Qualification:

  • Bachelor’s degree with 2-4 years of experience in bulk biologic GMP manufacturing.
  • Effectively uses process automation systems to operate production processes (i.e. Delta V).
  • Extended experience in Chromatography, Column packing and UF/DF processes.
  • Experienced reviewing and creating controlled documents.
  • Familiarity with deviation management systems (i.e. 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.
  • 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.
  • 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

Leadership Qualities:

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 company respected for the quality of its people and products.
  • Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.

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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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.

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