Manufacturing Team Leader

Position Summary & role expectations:

Biodextris is a contract development and manufacturing organization (CDMO) serving the biologics and vaccines industries. Our facilities are based in Laval, QC. 

Biodextris has an immediate opening for a manufacturing Team Leader position responsible for leading the GMP (Good Manufacturing Practices) manufacturing team while ensuring maintenance of the operational state of the cleanroom area and execution of bioprocess activities over the complete bioprocess workstream, including upstream cultivation, downstream purification while maintaining compliance to the GMP. 

Candidate must have proven knowledge of bioprocessing technologies with substantial experience within regulated industrial biopharmaceutical or life-sciences organizations. The qualified candidate will work closely with cross-functional teams to schedule, track, and complete manufacturing activities in accordance with regulatory requirements and industry best practices. The incumbent will report to the GMP Manufacturing Manager. 

Duties and Responsibilities:

• Planification of manufacturing deliverables, including: 
• Task distribution to team members for both manufacturing processes and cleanroom maintenance. 
• Coordination with supporting group (equipment maintenance, environmental monitoring, project management). 
• Batch production preparation (Material inventory, room clearance, personnel training). 
• Execution of manufacturing processes, including: 
• Upstream bacterial and mammalian cell-culture methods, including shake flask and bioreactor culture. 
• Downstream purification methods, including IEX, HIC, SEC Chromatography Tangential Flow Filtration. 
• Drug product (DP) manufacturing and filling activities. 
• Perform equipment set-up and preparation for manufacturing campaign. 
• Master batch record (MBR), Standard Operating Procedures (SOP) redaction and investigation of process deviations. 
• Documentation and electronic data recording in adherence with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines (GMP). 
• Provide support to cross-functional project teams from multiple disciplines including process and analytical development, quality control testing, quality assurance, operations support and validation. 
• Provide regular updates on work progression. 
• Maintenance of accurate documentation of all work in appropriate formats. 
• Practice safe work habits and adheres to company safety procedures and policies. 
• Any other relevant related tasks. 
• Training and coaching of manufacturing technicians. 
  

Education and Experience

Skills, Knowledge, and Abilities:

• Strong leadership and interpersonal skills. 
• Theoretical knowledge and functional experience in microbial/mammalian cultivation and downstream purification. 
• Strong aseptic manipulation knowledge and proven experience. 
• Experience with process execution in a GMP environment. 
• Attention to detail to ensure compliance with internal procedures. 
• Ability to work well with cross-functional teams and diverse groups of stakeholders. 
• Ability to work well independently as well as effectively in a team environment. 
• Excellent written, verbal communication and effective interpersonal skills. 
• Ability to prioritize tasks and manage time effectively. 
• Solves problems by integrating knowledge from several scientific/technical fields. 
• Capable of standing for long periods and performing repetitive tasks. 
• High level of initiative and adaptable to change. 
• Strong organizational skills, including attention to detail and ability to meet deadlines. 
• Ability to build credibility and trust.  

Application: Send resume and cover letter by email to hr@biodextris.com.