GID Technical Leader

CEVA Logistics; Brasil; Presencial; BRL 450 000 - 750 000; Tempo integral

Resumo da oferta

Ceva Animal Health is seeking a GID Technical Leader to drive scale-up and transfer of bioprocessing steps from development to manufacturing. You will optimize parameters across upstream, downstream, formulation, and lyophilization, leading cross-functional transfers and validation planning with KPIs and CQAs to ensure robust processes.

The role requires DoE/QbD expertise, knowledge of bioprocess systems, and strong English communication.

Qualificações

• Knowledge of bioprocess systems, including fermentors, bioreactors, filtration and tanks.
• Experience with DoE and QbD for process improvements and optimization.
• Familiarity with eukaryotic and prokaryotic cultures and growth kinetics.
• Proficiency in statistical tools and process simulation software.

Responsabilidades

• Lead scale-up/down and transfer efforts from development to industrial implementation.
• Drive optimization of upstream, downstream, formulation, and lyophilization processes.
• Define transfer and process improvement rationales considering technical, financial, and regulatory aspects.
• Lead meetings with stakeholders and monitor process performance via KPIs and CQAs.
• Draft validation strategies, protocols, and batch records; ensure SOP compliance.
• Mentor industrial operations, QA, RA teams on manufacturing process improvements.

Conhecimentos

Bioprocess systems

DoE & QbD

Culture knowledge

Statistical tools

Office & suite tools

Project management

English proficiency

Ferramentas

Minitab

Process simulation software

Descrição da oferta de emprego

GID Technical Leader

The success of a company depends on the passionate people we partner with.

Together, let's share our talents.

As a global leader in animal health, Ceva Animal Health believes our success is linked to our passionate people researching, developing, producing and supplying innovative health solutions for all animals, which contributes to the future of our diverse planet.

We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats) and wildlife.

Indeed, Our "Together, Beyond Animal Health" vision emphasizes that the health and wellbeing of people, animals and our planet are totally interlinked. More than ever, Ceva is committed to a "One Health" approach.

As part of our "Diversity, Equity and Inclusion" policy, Ceva Animal Heath is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants. To request an accommodation, please contact a member of the Ceva Talent Acquisition team.

Yourmissions :

• Lead scale-up/down and transfer efforts of new and existing processes from development to industrial implementation.
• Lead optimization efforts of current processes by conducting experiments to evaluate relevant process parameters for upstream, downstream, formulation, and lyophilization.
• Participate in the definition and implementation of transfer and process improvement/development rationales (including technical, financial, and regulatory aspects) to anticipate needs.
• Lead meetings with different stakeholders when needed.
• Evaluate and analyze process performance through KPIs, CQAs, and CCPs for process and methods development.
• Define and assist in process validation strategies (e.g. process validation protocols and batch records).
• Provide expertise to industrial operations, early R&D, QA, and RA teams as manufacturing process and industrialization expert for process improvement, optimal solution proposition and CAPEX evaluation.
• Exchange knowledge with other Global Industrialization (GID) teams and contribute to process improvement through sharingand promoting best practices.
• Ensure that relevant quality and EHS standards/rules and operating protocols and documentations for GID laboratories are followed.
• Participate in risk management meetings with other stakeholders, and define CPPs, CQAs, and systems suitability evaluation.
• Design, schedule, execute, and write protocols and reports.
• Adheres with documentation guidelines and current SOP´s related to experimentation and data reporting.
• Lead the installation, operation, and validation of new equipment. Also ensures equipment life cycle management.
• Participate in the creation of industrial documentation SOP´s, batch records, protocols, and others, to achieve right-first-time operations associated with new processes.
• Coordinate work streams;
• Actively participate in training programs;
• Actively participate, according to internal company policies, in projects, training, and events;
• Execute tasks in line with accountabilities and technical skills, using, developing, and suggesting tools (e.g. equipments, softwares, etc.);
• Execute other tasks compatible with requirements of the job function.

Yourprofile :

• Knowledge and application of Bioprocess systems (e.g. fermentors, bioreactors, filtration, TFF, tanks, etc.);
• Knowledge and application of DoE and QbD tools for process improvement;
• Knowledge in eukaryotic and prokaryotic cultures and growth kinetics;
• Knowledge and application of statistical tools (e.g. Minitab) and process simulation software;
• Proficient in Windows Office, Google Suite, with emphasis on Excel and Sheets;
• Project Management skills;
• Intermediate/Advanced Spoken English;
• Intermediate/Advanced Written English.