Specialist, Downstream Manufacturing - 9 months mission

KBI Biopharma

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KBI Biopharma is a trusted CDMO partner, working hand-in-hand with hundreds of clients worldwide. Partnering with KBI brings our years of integrated material solutions to your project.
Our mission is to accelerate the development of innovative discoveries into life-changing biological products and expand global access of medicines to patients in need.

Specialist, Downstream Manufacturing - 9 months mission

9-month mission; Ideal starting date : 01 January 2023

Job summary

Responsible for technical activities for GMP Manufacturing Operations in a multi-products biopharmaceutical facility.

This position includes supporting safety, compliance, quality, scheduling, production record generation and revision, production process execution, equipment onboarding, process improvement projects ownership and manufacturing training.

The individual will also assist to tech transfer and new project integration activities for manufacturing, record generation, equipment enrollment, operation, and maintenance, and conduct operational excellence initiatives for the department.

The DSP Manufacturing Specialist will report to the Associate director of DSP department. 

The individual will be responsible for managing the day-to-day, and mid-term schedule planning and be the primary point of contact for daily issue escalation.

The individual will ensure strict accordance with SOPs and Good Manufacturing Practices. The individual will also be responsible for overwatching cross-functional operations are both reliable and successful.  This requires a drive for continuous improvement and simplicity and looking for opportunities to ensure equipment operation is reliable. 

This proven and qualified candidate will use their past experiences, depth, and knowledge from fundamentals, like media/buffer preparation, USP or DSP operations to teach, troubleshoot and continuously improve the production operations.

 

Job Responsibilities

  • Oversee manufacturing activities including: manufacturing record generation, MRP BOM and work order generation, and enrollment of materials and equipment 
  • Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed 
  • Ensure staff maintain a high level of compliance to procedures and quality expectations. 
  • Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed 
  • Ensure equipment and manufacturing facilities remain in working order by overseeing manufacturing specialists and ensuring that vendor repairs who will production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair. 

 

Minimum Requirements

  • Bachelor’s degree in a related scientific or engineering discipline and 4+ years’ experience in related GMP manufacturing operations  
  • Demonstrated knowledge of purification unit operation is required. Experience in single-use platform technology is preferred.  
  • Good written and verbal communication skills are required
  • Energetic, motivated and dynamic individual. 
  • Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor. 
  • Fluent in French Language both reading and writing. Communication abilities in English is preferred.
  • Ability to speak effectively before groups of customers or employees of organization.
  • Computer Skills :MS Office, ERP, EDMS, production equipment software, other  
  • Equipment Use: Peristaltic Pumps, chromatography skids and Other Single Use pumps, Balances, pH and Osmolality meters, Other lab equipment, other production equipment, and Office Equipment
  • Open to work on on-call activities

 

Contact

  • Sophie Darthenay
  • KBI Biopharma

No recruitment agencies please

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