Tech Transfer senior engineer

Contenido de trabajo

Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are fully committed to helping their clients fulfill their objective of providing sustainable and affordable therapies to their patients.

To lead its increasing number of development and manufacturing projects, Catalent Cell and Gene Therapy is looking for a highly motivated Technology Transfer Senior Engineer.

The Role

The Technology Transfer Senior Engineer reports to the Head of department.

The Technology Transfer Senior Engineer’s main role is to lead the transfer and validation of process & analytical methods ensuring a proactive vision of the strategy to be used across different projects and activities.

This will lead to an effective cGMP status for the validation and effective Tech Transfer from P&AD or from the customer.

The Sr Engineer will also act as a referent either within the team, the company and customer.

She/He will also play a significant role within the New Technology, Knowledge management or Site Support.

Finally, the role will deputize for the MSAT director.

Scientific lead on Analytical Methods AND Process Transfer/Validation (A&PMT/A&PMV):

• Review or draft as needed PMT/PMV and AMT/AMV protocols & reports
• Ensures that the discussed strategy is translated into validation protocol and experimental plan and communicates with PL in charge of the method
• Follows up of experiments related to A&PMT/A&PMV and performs statistical data analysis
• Coordinate and handle draft, design and review of AMT/AMV protocols & reports
• Approve a fit for purpose approach for A&PMV depending on clinical Phase of the study and requirements of the customer mainly for critical projects.
• Is responsible for implementing strategies and monitoring Bridging/Control Charts within the company
• Participates, as a referent, in customer meetings for topics related to A&PMT or A&PMV
  
  

Site and Process &Analytical Development Support

• Work closely with P&AD during the diagnostic phase through the detailed gap analysis in order to assess the potential of a new process or method to be validated under cGMP requirement as appropriate.
• Takes part in big project investigations and CAPA to lead teams.
• Trouble shooting on analytical or process adjustment needed.
• Be the interlocutor for Process and analytical or any technical explanation during regulatory inspection from National Authorities.
  
  

Communication:

• The MSAT Sr Engineer is an active member of the department management team.
• Promote and ensure productive communication between team and management
• Warns the Head of Department in case of problems
• Maintains open and effective communication with all other departments
• Vehicles CTLT values
• Ensure effectiveness of interface activity with QC, Mftg and P&AD.
• Ensures respect of meaningful KPI within MSAT
• Ensures GMP compliance and implementation of CTLT’s QMS, product quality and team driven by patient safety
  
  

Knowledge Management

• Will work on a strategy to deliver a Process History File able to capitalize on the process & analytical knowledge acquired along project.
• Establish and deliver comprehensive scientific and technical training package for other department like manufacturing or QC.
• Work closely with S&T to implement a continued process verification process.
  
  

Continuous improvement

• Sets up generic templates for all A&P validation activities and follow up for continuous improvement
• Is a referent for generic continuous improvement when required (e.g. from QC or mftg)
• Keep a proactive and up-to-date analytical profile regarding industry/corporate requirements
  
  

Budget

• Determines the impacts of a project scope change on resources and timelines of his/her project(s) and then reports his/her conclusions to responsible people
  
  

Audits/prospects

• Takes part in audits/prospects when necessary.
• Accountable for analytical/Process validation strategy a well as for Tech transfer.
• Be the principal referent in case of regulatory inspection coaching other MSAT Eng colleagues.
  
  

People Management within the MSAT team

• Act as a coach/mentor for the team.
• Sets up annual’s SMART objectives.
• Ensures human well-being by a good private/professional life balance while preserving team spirit and good work atmosphere.
  
  

Soft Skills

• Confirmed team player
• Efficient communicator and demonstrate diplomatic skills
• Demonstrated leadership and assertiveness
• Demonstrates initiative and ability to meet deadlines
• Ability to manage discussion with clients/Project Leader
• Affinity with statistics
• Ability to be transversal; multi-task; can work in multi projects / multi departments environment
• Excellent verbal and written communication skills to convey and receive ideas and instructions to/from others within the organization
• Excellent writing skills
• Strong organizational skills
• Passionate and cheerful
• Hands-on mentality
• Quality-oriented, rigorous
• Patient and customer-oriented
  
  

Experience

• 10 years of experience in a cGMP biopharmaceutical environment.Or Proven experience in Process and analytical methods validation and statistics, tech transfer
• Experience in cell therapy or quality control of cells from human tissue origin is a plus.
• Experience in biopharma environment and Inspection readiness at the highest level ( FDA or equivalent) is a must.
• Fluency in French and Excellent written and spoken English
  
  

Catalent’s standard leadership competencies that are used to interview and for Performance & Development:

• Delivers Results
• Leads with Integrity and Respect
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops
  
  

Position Benefits

• Full-time position (40h/week).
• An indeterminate contract.
• The opportunity to take part in a growing dynamic biotech company.
• A human-sized working environment with a convivial atmosphere.
• Attractive salary packing including additional benefits.
  
  

Catalent offre des opportunités enrichissantes pour faire avancer votre carrière! Rejoignez le leader mondial du développement et de la production de médicaments et aidez-nous à proposer plus de 7 000 produits qui sauvent et améliorent la vie des patients du monde entier. Catalent est une société internationale passionnante et en pleine croissance où les employés travaillent directement avec des sociétés pharmaceutiques, biopharmaceutiques et de santé grand public de toutes tailles pour faire progresser de nouveaux médicaments, du développement précoce aux essais cliniques et à la mise sur le marché. Catalent produit plus de 70 milliards de doses par an, et chacune sera utilisée par quelqu’un qui compte sur nous. Rejoignez-nous pour faire la différence.

Catalent s’engage à protéger la santé et la sécurité de ses employés, de ses visiteurs et des clients et patients que nous servons. À la suite de la pandémie mondiale, nous avons modifié bon nombre de nos processus de recrutement et d’intégration pour assurer la sécurité de tous. Les équipes des ressources humaines communiqueront tous les processus et procédures de sécurité nécessaires à chaque étape.

Initiative personnelle. Rythme dynamique. Un travail significatif.

Visitez Catalent Careers pour explorer les opportunités de carrière.

Catalent est un employeur garantissant l’égalité des chances et ne fait aucune discrimination sur la base d’une caractéristique protégée par la législation locale.

Si, en raison d’un handicap, vous avez besoin d’un aménagement raisonnable pour une partie ou plus du processus de candidature ou d’embauche, vous pouvez soumettre votre demande en envoyant un courriel et en confirmant votre demande d’aménagement et en incluant le numéro de poste, le titre et le lieu à DisabilityAccommodations@catalent.com. Cette option est réservée aux personnes ayant besoin d’un aménagement en raison d’un handicap. Les informations reçues seront traitées par un employé de Catalent aux États-Unis, puis acheminées vers un recruteur local qui fournira une assistance pour assurer une prise en compte appropriée dans le processus de candidature ou d’embauche.

Avis aux représentants des agences et des cabinets de recherche : Catalent Pharma Solutions (Catalent) n’accepte pas les curriculum vitae non sollicités d’agences et/ou de cabinets de recherche pour cette offre d’emploi. Les curriculum vitae soumis à tout employé de Catalent par une agence tierce et/ou une société de recherche sans un accord de recherche écrit et signé valide, deviendront la propriété exclusive de Catalent. Aucuns frais ne seront payés si un candidat est embauché pour ce poste à la suite d’une recommandation non sollicitée d’une agence ou d’un cabinet de recherche. Merci.