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if you want to work:

in one of the most modern biotechnology
centres in Europe
 
in place where profesionals
from all over the world work
on the highest-quality equipoment
 
in the production
of biotechnological
drugs, which dive access
to effective therapy to
more patients
 
in a company that will dive you stable employment competetive remuneration attracive benefits and the opportunity to participate in training at home and abroad
 
Currently we’re looking for
Head MS&T

Join “start-up” Biologics division with strong international and local team at site!

 

 
We are waiting just for you!


 
 

Key responsibilities:

•            Establish and maintain MS&T organizational capability and governance processes to ensure products and technologies are within validation and current technology standards

•            Lead validation and ensure execution of Validation Master Plans and continuous data monitoring/trending

•            Keep technology strategies to current and future standards in partnership with key functions (Production, Development, QA/Regulatory, Business)

•            Execute product remediation of technical issues and provide technical support

•            Product Stewardship: full accountability and oversight of product related technical process and quality aspects to ensure manufacturing of robust products (Lifecycle Management of a production process)

•            Technical Stewardship: Oversight and definition of processes and standards to maintain    existing technologies and implement new innovative technologies for manufacturing including the development of requirements for new equipment

•            Technical Transfer Leadership: Lead technical transfers of products within and between sites as well as from development into large scale facilities

•            Process Support Leadership: Ensure end-to-end oversight of process performance and early initiation of corrective actions based on monitoring of product/process parameters. Ensure current process technical issues are solved in a timely manner, drive implementation of CAPAs etc.

•            Validation Leadership: Own and write VMP. Provide governance for site validation activities. Perform scientific evaluation/risk assessments of APR/PQR, CPP/CQA, CPV

Requirements:

•            5-8 years of experience in manufacturing/manufacturing science or technology/technical development

•            Thorough understanding of manufacturing processes (Up- & Downstream) and related process equipment

•            2-5 years of experience in executing process validation, having led and managed validation projects

•            Expert in reviewing and writing technical reports

•            Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions)

•            Strong in leadership and people management, with ability to build up and develop the team

•            Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities

•            Fluent in English, willing to learn Polish language

•            Flexible and adaptable

 

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