Job Description

Resume du poste et attentes

Biodextris est une organisation de developpement et de fabrication a contrat (CDMO) dans le secteur des produits biologiques et des vaccins. Nos installations sont situees a Laval, au Quebec.

Nous recherchons actuellement un candidat qualifie pour un poste de chef d'equipe de production. Le/La candidat(e) sera charge de diriger l'equipe de production BPF (Bonnes pratiques de Fabrication) tout en assurant le maintien du bon fonctionnement des salles blanches et l'execution des activites de bioprocedes sur l'ensemble du flux de travail, incluant la culture cellulaire et bacteriennes et la purification tout en respectant les BPF.

Le/La candidat(e) doit posseder une connaissance accrue des technologies de bioprocedes et une solide experience au sein de l'industrie biopharmaceutiques ou des sciences de la vie. Le/La candidat(e) qualifie(e) travaillera en etroite collaboration avec des equipes multidisciplinaires pour planifier, suivre et mener a bien les activites de fabrication conformement aux exigences reglementaires et aux meilleures pratiques de l'industrie. Le/La titulaire du poste reportera au/a la responsable de la fabrication BPF.

Resume du poste:

Planification des livrables de production, incluant:
Repartition des taches entre les membres de l'equipe pour les procedes de fabrication et la maintenance des salles blanches.

Coordination avec les groupes de soutiens (maintenance des equipements, echantillonnage environnementale, gestion de projet).

Preparation des campagnes de production (inventaire de materiel, vide de ligne, formation du personnel).

Execution des procedes de fabrication, incluant:
Culture bacterienne et de cellules de mammiferes en flacon et en bioreacteur.

Procedes de purification incluant les methodes de chromatographie IEX, HIC, SEC et la filtration tangentielle.

Preparation et activites de remplissage du produit fini.

Assemblage et preparation des equipements pour les campagnes de production.

Redaction des dossiers maitres de production, des procedures operatoires normalisees (PON) et investigation des deviations aux procedes.

Soutien aux equipes multidisciplinaires, incluant les equipes de developpement des procedes, de developpement analytique, de controle qualite, de l'assurance qualite, du soutien operationnel et la validation. Fournir regulierement des mises a jour sur l'etat d'avancement des travaux. Tenue d'une documentation conforme de tous les travaux. Adopter des habitudes de travail securitaires et respecter les procedures et politiques de securite de l'entreprise. Toute autre tache connexe pertinente. Formation et encadrement des techniciens de fabrication.

Education et experience

Diplome dans le domaine des biotechnologies, biochimie, genie chimique/genie de procede, microbiologie ou autre domaine connexe avec un minimum de 5 ans d'experience ou une formation combinee equivalente avec une experience de travail pertinente.
Les experiences acquises lors de stages ou d'etudes superieures sont prises en compte lors de l'evaluation.

Competences, connaissances et aptitudes

Excellentes competences en leadership et en relations interpersonnelles. Connaissances theoriques et experience pratique en culture microbienne/mammifere et en purification. Solides connaissances en manipulation aseptique avec experience. Experience en execution de procedes dans un environnement BPF. Souci du detail pour garantir le respect des procedures internes. Capacite a travailler efficacement avec des equipes multidisciplinaires. Capacite a travailler de maniere autonome et efficace en equipe. Excellentes competences en communication ecrite et orale et excellent relationnel. Capacite a prioriser les taches et a gerer efficacement son temps. Resout les problemes en integrant des connaissances issues de plusieurs domaines scientifiques et techniques. Capacite a rester debout pendant de longues periodes et a effectuer des taches repetitives. Grand sens de l'initiative et adaptabilite au changement. Solides competences organisationnelles, notamment souci du detail et capacite a respecter les delais. Capacite a instaurer la credibilite et la confiance.
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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.

Position Summary

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

Degree in biotechnologies, biochemistry, Chemical/Process engineering, Microbiology, or related field with a minimum of 5 years of related experience or equivalent combined education with relevant work experience.

Experience acquired during internships or graduated studies are considered in the evaluation of the amount of related 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.
Type d'emploi : Temps plein

Avantages:

Assurance Dentaire Assurance Maladie Complementaire Conges payes
Formation:

Baccalaureat (Obligatoire)
Experience:

biotechnologies, biochimie, genie chimique/genie de procede: 5ans (Souhaite)
Lieu du poste : En presentiel