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(Senior) Technical Operations Engineer

Company: Principia Biopharma Inc.
Location: Framingham
Posted on: May 31, 2021

Job Description:

At Kiadis Pharma, a Sanofi Company, we are leveraging the natural strengths of humanity and our collective immune systems to source the best cells for life. Our NK cell (natural killer cell) research and development programs and partnerships are at the cutting-edge of the industry, paving the way for new and exciting therapies, in immuno-oncology and beyond.

In support of developing our innovative NK cell therapies, we are looking for a (Senior) Technical Operations Engineer, home-based in the United States (preferably East Coast).

The role

As a (Senior) Technical Operations Engineer, you are part of the Technical Operations Team which is responsible for ensuring the reliability, capacity, and quality of the Kiadis manufacturing operations at our US based Contract Manufacturing Organizations (CMOs). Together with your colleagues you manage and optimize existing production processes and technologies, by monitoring and understanding their performance and leading improvement opportunities. In addition, you are responsible for the resolution of escalated process deviations or investigations. In your day-to-day work you will:

  • Define and manage manufacturing-related change controls, quality events, and CAPAs.

  • Manage and improve the technology knowledge on processing and manufacturing in collaboration with your Process Development colleagues. Act as subject matter expert and proactively identify new trends and opportunities.

  • Provide expert support, guidance, and training to production staff related to technology, process, aseptic handling.

  • Help assess the feasibility of new equipment, processes, and changes to established processes or equipment and lead the implementation.

  • Represent the manufacturing organization during the development of new processes. Lead risks assessments, GAP assessments, the "fit for manufacturing/process fit to plant" process.

  • Monitor process performance together with Quality Assurance, and Process Development. Including Identifying and proposing the resulting required changes.

  • Select raw material suppliers and perform impact assessments of vendor changes in collaboration with Quality Assurance, Manufacturing, and Process Development.

  • As needed, supports the review of incoming material related documentation

  • Acts as a subject matter expert towards the Process Development team and process monitoring activities

  • Collaborate with Quality Assurance to secure the release of clinical materials, and review and approve of cGMP documentation

The department

The Kiadis Operations team is responsible for all aspects of CMC development, manufacturing, procurement, planning, and customer service within Kiadis. We are a group of experienced professionals - cell therapy experts, biologists, engineers, analysts, manufacturing technicians, and more, driven by the passion to develop and supply innovative cell therapy products, directly to patients. We work through a global network of internal and external laboratories and production facilities and interact on a daily basis with apheresis centers and hospitals around the world. Join us and see for yourself how your talent and skills will bring us closer to our ultimate goal: helping patients worldwide.

The ideal candidate

We are looking for someone who shares our love for cells and process technology and likes being part of a dynamic organization. Someone that is an excellent team player and communicator, has a strong sense of quality, and is pragmatic. In addition, we are looking for someone with the following requirements:

  • BSc or MSc in cell biology, biotechnology, bioprocess technology, or a related field.

  • Minimum of 3 years of working experience in a relevant field, preferably in industrial cell therapy, biologics, vaccines, or upstream biologics manufacturing.

  • Strong understanding of state-of-the-art practice in biologics or the cell therapy field

  • Strategic forward-thinking manner, with the ability to communicate with people at all levels of an organization.

  • Self-directed with a strong operational focus.

  • Organized, bringing focus and structure into projects.

  • Fluency in English, other languages are a plus.

  • Availability to travel up to 10% to CMOs/contractors and to AMS headquarters

What we offer

People from all over the world, together as one team, contribute to improving the lives of patients every day. We offer an exciting position in an innovative, dynamic, and inspiring environment where you'll receive a competitive remuneration package, autonomy, and the opportunity to make your own mark within Kiadis.

We create an environment where ideas are shared, experiences are impactful, and talent is developed. Because of our inclusive and family-like environment, you will always have the feeling of belonging & appreciation.

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.

Keywords: Principia Biopharma Inc., Framingham , (Senior) Technical Operations Engineer, Other , Framingham, Massachusetts

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