Company
biopharmaceutical
SeniorExpertScience&Technology–DownstreamProcessDevelopment
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Expert Science & Technology – Downstream Process Development. Skills: Downstream Process Development, chromatography, filtration, process development, process characterization, technology transfer. Lead and organize the downstream process development activities for portfolio pipeline projects. Perform chromatography steps, cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins as part of process development and cha”
What You'll Achieve.
bringing innovative biopharmaceutical drugs to the market; drive innovation and efficiency; supporting development and submission initiatives; ensuring that development strategies are aligned with business goals; Successful execution of assigned tasks within given timelines at expected quality, right first time & right in time; contribute to overall TRD strategies and goals
Industry & Context.
Excellent problem-solving skills; ability to think critically; lead troubleshooting
What They're Looking For.
Must Have
Completed studies in Biotechnology, Process Engineering, Biology, Biochemistry, Pharmaceutical Technology, Technical Chemistry, Pharmacy, several years of industry experience, Experience in Downstream Processing, experience with chromatography systems, experience with cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins, Experience with electronic documentation systems, Experience with international registration documents, Experience with technology transfers, Experience with definition of process steering controls, Experience with lab procedures, reports and / or instructions and / or Standard Operating Procedure’s, Experience with troubleshooting, Experience with transfer of know-how to other departments or external partners, Experience as Functional Lead for DSP development projects, Experience participating in sub-teams, Experience contributing to overall TRD strategies and goals, Experience supporting decision-making, English (required)
Nice to Have
German (preferred but not mandatory), Proficiency in programming languages such as Python, R, or SQL is a plus, Understanding of regulatory requirements and CMC development processes, Ability to work with a cross-functional team in a matrix environment
What You'll Do.
Lead and organize the downstream process development activities for portfolio pipeline projects
Perform chromatography steps
cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins as part of process development and characterization at laboratory and pilot scale
perform and document scientific studies
handle several activities at a time
Documentation of the studies in electronic documentation systems according to defined standards
Evaluate and interpret results
propose and actively support the design of next experiments
supervise project related activities
perform complex tasks without having established procedures of downstream processes
Work according to appropriate standards for quality
environment protection
and information security
lead initiatives to ensure continuous improvement
Generate scientific documents to hand over to internal and / or external partners
support generation of international registration documents under minimal supervision
Contribution to technology transfers to internal and external sites
definition of process steering controls
Support the organization of the generate lab procedures
reports and / or instructions and / or Standard Operating Procedure’s
Successful execution of assigned tasks within given timelines at expected quality
right first time & right in time
Communicate effectively across organizational interfaces
lead troubleshooting and transfer of know-how to other departments or external partners
Act as Functional Lead for DSP development projects
participate in sub-teams
contribute to overall TRD strategies and goals
support decision-making
How You'll Work.
Team & Collaboration
Work with a cross-functional team in a matrix environment; Communicate effectively across organizational interfaces; transfer of know-how to other departments or external partners; participate in sub-teams; contribute to overall TRD strategies and goals
Communication Scope
Excellent communication and collaboration skills; communication across organizational interfaces
Process & Methodology
Lead and organize the downstream process development activities for our portfolio pipeline projects, supervise project related activities, Successful execution of assigned tasks within given timelines at expected quality, right first time & right in time
Full Job Description
**Job Description Summary** Location: Schaftenau, Austria #onsite Role Purpose: Our Downstream Development team plays a crucial role in the late-phase development and transfer of biopharmaceutical drug substance (DS) processes. We are contributing significantly to bringing innovative biopharmaceutical drugs to the market and are dedicated to leveraging data science and digital initiatives to drive innovation and efficiency. We are currently seeking a highly skilled and motivated Senior Expert to join our dynamic DSP Development team. In this role, you will be responsible for leading our portfolio pipeline projects in downstream process development. Your expertise will be crucial in supporting our development and submission initiatives, ensuring that our development strategies are aligned with our business goals. **Job Description** **Major Accountabilities:** * Lead and organize the downstream process development activities for our portfolio pipeline projects * Perform chromatography steps, cross flow filtration / tangential flow filtration and other membrane separation methods for purification of recombinant proteins as part of process development and characterization at laboratory and pilot scale * Independently plan, organize, perform and document scientific experiments; handle several activities at a time * Documentation of the studies in electronic documentation systems according to defined standards * Evaluate and interpret results, propose and actively support the design of next experiments supervise project related activities; perform complex tasks without having established procedures of downstream processes. * Work according to appropriate standards for quality, ethics, health, safety, environment protection, and information security, lead initiatives to ensure continuous improvement; all activities have to be aligned with organizational workflows and procedures * Generate scientific documents to hand over to internal and / or external partners and support
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