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Sr Bioprocess Specialist
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.
Your
missions :
Location: Lenexa, KS
| Job Summary and Purpose: |
The Sr Bioprocess Specialist is responsible for providing scientific, technical and equipment support regarding the development of new products and existing product changes. This position will design, plan, lead and execute strategies associated with the new process development, troubleshooting, or optimizations that are aimed at delivering reproducible, safe, compliant, and cost effective solutions to the industrial teams.
| Responsibilities and Key Duties: |
- Lead the development of state-of-the-art, robust, and cost-effective biological production processes from laboratory to industrial scale including roller bottles, multi-plate cell culture systems, bioreactors, fermenters, inactivation, downstream processing, formulation, and lyophilization for new and existing products.
* Lead optimization efforts of current processes by conducting experiments to evaluate relevant process parameters for upstream, downstream, formulation and lyophilization applying DoE and QbD methodologies.
* Implement the transfer of processes/methods into Industrial Operations and between international campuses.
* Evaluate/analyze process performance (KPIs, CQAs, and CCPs) for process/methods improvement.
* Define and evaluate process validation strategy, assist with the generation of process validation protocols and manufacturing instructions, check and approve process validation protocol and manufacturing and testing instructions and write technology transfer plans and reports.
* Provide expertise to production, early R&D, QA and RA teams as manufacturing process/industrialization expert for process improvement, optimal solution proposition and CapEx evaluation.
* Exchange knowledge with other Global Industrialization teams and contribute to process improvement through sharing and promoting best practices.
* Ensure that relevant quality and EHS standards/rules and operating protocols and documentations for GID laboratories are followed.
* Participate in risk assessment meetings with R&D, GMSQ and Purchasing teams to identify and define critical process parameters and critical quality attributes for systems suitability evaluation.
* Design, schedule, execute and write tech transfer and analytical protocols and reports.
* Update and write GMP procedures and implement corrective and preventive actions.
* Adheres to documentation guidelines and current SOPs related to experimentation and reporting data.
* Lead the installation, operation and validation of new equipment ensuring maintenance of equipment and operational status.
* Conduct training for different team members on the proper use of equipment or processes.
* Lead the effort in the creation of industrial documentation SOPs and batch records to achieve right first-time operation associated with new processes.
* Schedule batch manufacturing and ensure that the right resources are allocated.
| Core Competencies: |
* Shape solutions out of complexity - Is open and curious of other's perspectives.
* Client focus - Has in mind client's satisfaction
* Collaborate with empathy - Has a positive attitude towards collaboration.
* Engage and develop - Clarifies short-term directions.
* Drive ambition and accountability - Proactively manages own and others work.
* Influence others - Communicates transparently.
| Technical / Functional Competencies: |
* Experience/knowledge of bioprocesses, bioreactors, fermentation, cell culture, formulation, lyophilization in Research, Production and/or Manufacturing environment is preferred.
* Strong background working with multiple cell lines and small and large scale bioreactor and fermentation equipment (Example: Applikon, Wheaton, ABEC, Braun, Eppendorf, Wave, New Brunswick, Hyclone SUB's, etc.).
* Strong background with training and troubleshooting skills desirable.
* Ability to interact within the group and cross-functional and collaborative teams.
* Knowledge of GMP and GLP procedures is desirable.
* Strong communication skills, both written and verbal
* Technical writing skills for regulatory documentation
* Project management skills
* Data management and analysis tools knowledge
* Capability to prepare URS for production line.
* Ability to contribute to building an industrialization strategy from the design of new equipment and its integration into new premises.
* Ability to scout and evaluate the potential of new technologies.
* Ability to design and perform capability/robustness studies.
| Qualifications: |
Education - MS/PhD in Biology, Microbiology, Virology, Biochemistry, Chemical Engineering or equivalent
Work Experience - Prefer a minimum of 3-5 years of experience within a cGMP biological production environment, with managerial experience, or an equivalent combination of education and experience.
Other (consider certifications, specialized knowledge and/or training, etc.) -
| Physical Requirements: |
* Ability to read, write legibly and understand English.
* Visual inspection
- Lifting, carrying, pushing, up to 25lb
- Frequent period of standing, Bending, walking, and sitting
| Working Conditions: |
* N/A
| Travel Required: |
* N/A
This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA Federal Contractor
**Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.
669B
Your profile :
Education - MS/PhD in Biology, Microbiology, Virology, Biochemistry, Chemical Engineering or equivalent
Work Experience - Prefer a minimum of 3-5 years of experience within a cGMP biological production environment, with managerial experience, or an equivalent combination of education and experience.