Scientist, Late Stage Process Development at SANOFI GENZYME

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Job description:
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

Genzyme Corporation (a Sanofi company) 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.

Job Responsibilities/Department Description:

The department of Purification Development in Late Stage Process Development is responsible for development, scale-up, transfer and characterization of downstream processes for late stage clinical and commercial manufacturing of therapeutic proteins, hormones and antibodies. In addition, the department develops second generation commercial processes, provides technical expertise and support to improve on-going commercial manufacturing process performance, evaluates new technologies and develops platform technologies suitable for incorporation into commercial processes. We are looking for candidates at the position of Staff Scientist II (chemical engineer, biochemist/biologist/other). The incumbent will be part of a teams dedicated to accomplishing the department’s objectives. We are looking for a leader who is creative and innovative and can develop downstream processes for purifying a protein or hormone of interest from crude mammalian harvest feeds, lead process and project teams within the department and external to the department, globalize Genzyme approaches and practices and examine new and disruptive technologies. This individual must also ensure that the highest standards of safety and environmental compliance are maintained in the workplace; and operate under the regulatory requirements for biologics product development and manufacturing.

See Also
Covance B Pharma Job 2020 - Asst II PSS Post Vacancy

Major Job responsibilities and requirements:

  • May lead a small group of individuals of bachelor to Ph.D. level and lead multiple projects
  • Lead the development of robust downstream processes that can be scaled to large chromatography unit operations.
  • Lead scaling up and implementation of downstream processes at manufacturing scale. Lead the examination of novel downstream technologies for manufacturing therapeutic proteins.
  • Lead efforts to achieve better understanding of licensed purification processes with emphasis on scale down model development for supporting on-going commercial manufacturing and productivity improvement.
  • Provide scale-down support for manufacturing excursions, deviations and other challenges
  • Provide comprehensive packages that support equipment design and process technology transfer to manufacturing site(s)
  • Conversant with/in DOE, MVA, APC and other techniques used to determine the Design and Operating Space for downstream processes.
  • Serve as a subject matter expert on protein purification and engineering.
  • Lead efforts with colleagues from across Genzyme sites to achieve standardization and harmonization of downstream development and manufacturing practices.
  • Keep abreast of new developments and technologies in areas of downstream processing. Attend and present at external technical forums to remain current with technology and regulatory guidelines.
  • Publish in first class technical journals.
  • Manage direct reports

Qualifications
Basic Qualifications:
· PhD in Biochemistry/chemical Engineering (or equivalent) with 3-6 years of industrial experience in development of downstream process for manufacturing of hormones and recombinant proteins including monoclonal antibodies.
· Experience in managing others and a proven track record of presentations and publications

Preferred Qualifications:
· Having scaled up the processes and provided manufacturing support for the processes is desirable.
· Familiarity with US and international regulatory documentation and requirements and international regulatory and quality guidelines in the biopharmaceutical industry.
· Exceptional interpersonal skills and ability to work effectively in a matrix organization.
· Excellent organizational and communication skills.

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