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Drug Substance Manufacturing Associate-Biologics

Company: Sanofi US Services Inc.
Location: Framingham
Posted on: May 3, 2021

Job Description:

Sanofi, an integrated global healthcare leader, discovers, develops and distributes transformative therapies for patients affected by rare and debilitating diseases. We are dedicated to discovering and advancing new therapies focused on patients' needs, providing hope to patients and their families around the world. We accomplish our goals through world-class research, collaboration and forging close relationships with global physician and patient communities, and with the compassion and commitment of our employees. Sanofi's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine.Position Overview:As part of the Sanofi Biologics Development organization in Framingham, MA, the Drug Substance Manufacturing Biologics (DSMB) Department supports biologics manufacturing activities for early stage biotherapeutic clinical product candidates in a regulated cGMP multi-product pilot facility. The DSMB-Buffer Media Prep (BMP) group operates in a clean-room production suite to perform large-scale buffer and media preparation, equipment preparation, clean-in-place (CIP), and Preventative Maintenance of process equipment in support of upstream (cell culture) and downstream (purification) operations to produce protein drug substance suitable for First in Human and later stage clinical trials.Full-time Monday-Friday 8 hour day shift (7:00AM - 3:30PM). May require some overtime work - schedule dependent.This is an upstream position in the DSMB-Buffer Media Prep group at 76 New York Avenue, Framingham, MA facility. Primary accountability is to participate, both independently and as part of a team, in a diverse range of clinical manufacturing related activities that involve the preparation of bulk solutions, filling, and labeling under sterile/non-sterile conditions in a regulated cGMP environment. Good documentation practices and strict adherence to SOPs and batch production records are required. Activities include routine buffer/media preparation, aseptic filtration, setting up and disassembling process equipment, cleaning, autoclaving and maintaining of equipment, maintaining supplies, and basic troubleshooting systems. Participate in writing SOPs and batch production records and coordinate activities with other support functions (i.e., Quality, Engineering, Validation, Metrology, and Facilities). Ability to operate equipment using batch production records and SOPs in accordance with cGMPs, Global Sanofi Standards, and safety guidelines under limited supervision.Key Responsibilities:This position is part of a team to perform manufacturing processes in a regulated cGMP multi-product pilot facility as follows:Practice and promote safe work habits and adhere to Sanofi's safety procedures and guidelines.Effectively demonstrate knowledge and understanding of cGMPs and how they apply to specific responsibilities.Follow verbal and written procedures in operating production equipment and performing processing steps; accurately complete and/or review appropriate production documentation.Build, clean, autoclave, and operate equipment to support large scale buffer/media preparation, protein purification and cell culture operations.Perform component weighing, batching of buffer and media, sterile/clarification filtration and aseptic technique in a cGMP environment.Perform aseptic operations independently in a clean room environment.Identify, escalate and document events and subtle variances that deviate from normal operation; participate as needed in deviation/nonconformance identification and resolution.Maintain cleanliness and orderliness of manufacturing and process area(s).Maintain production area with supplies.Participate in the creation/review of documents including batch production records, manufacturing procedures, and cross functional procedures by providing input to the technical composition of the documents.Work with vendors concerning troubleshooting, repair and ordering of spare parts relevant to manufacturing equipment.Utilize manufacturing knowledge and investigation skill sets to help identify and troubleshoot basic mechanical operations or routine processing issues, improve process operations and affect positive change.Interact/coordinate activities with other support functions, such as Quality Assurance, Quality Control, Manufacturing Engineering, Validation, Metrology and Facilities.Liaison with Metrology department to ensure equipment is calibrated for GMP use.Assist with training less experienced or new operators in specific technical process.Assist with general maintenance and qualification of manufacturing equipment.Interact with the Process Development group during the technical transfer of new programs.Basic Qualifications:Biotechnology certificate or Associate's degree in biology/chemistry.Experience with buffer, media, and equipment preparation.Demonstrated understanding of application of sanitization practices.Demonstrated knowledge of equipment prep and solution prep processes.Demonstrated knowledge of Autoclave and associated use activities.Demonstrated knowledge of filtration/dispensing operations.Understanding of GMP and how it applies to specific responsibilities and manufacturing operations.Ability to work in a team environment.Preferred Qualifications:Biotechnology certificate or Associates degree in biology/chemistry with a minimum of 2 years of experience or Bachelor's degree with a minimum of 1 year of experience in cGMP manufacturing environment.Experience with Large-scale buffer/media and equipment preparation, ideally at pilot scale.Understanding of GMP and how it applies to specific responsibilities and manufacturing operations.Strong verbal and written communications, effective time management, and organizational skills are essential.Must be self-motivated, detailed oriented, flexible, team oriented, and demonstrate good troubleshooting skills.Proficiency in aseptic technique.Familiarity with Microsoft Word and Excel.Special Working Conditions:May involve work with hazardous materials.Ability to work standing for extended periods of time.Requires physical demands of bending, stretching, pushing, pulling, and lifting up to 30-35 pounds.Ability to gown and work in clean room environment.Sanofi US Services, 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.#GD-SA#LI-SAAt 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.

Keywords: Sanofi US Services Inc., Framingham , Drug Substance Manufacturing Associate-Biologics, Other , Framingham, Massachusetts

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