8 days old

Senior Manager (m/f/d) Process Analytical Technology (PAT) & Automation

Pfizer
Freiburg
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The Senior Manager Process Analytical Technology and Automation will



+ Actively drive the development and implementation of new control strategies, PAT technologies, and related automation that will be suitable for routine use in a GMP manufacturing environment

+ Implement technology solutions and PAT applications that assure high-quality, un-interrupted manufacturing

+ Represent the PPD Freiburg, PAT activities globally and act as a strategic partner to internal and external stakeholders

+ Track government positions on PAT and continuous manufacturing, contribute to scientific discourse, and implement related control strategies in full compliance with regulatory and quality requirements

+ Will be the primary contact to present and explain PAT solutions for new products in BOH inspections



Activities include (but not limited to),



+ responsible PAT project work in co-development teams

+ planning, implementation and coordination of PAT activities and investments

+ advise on, transfer, and support, PAT projects in the worldwide PGS network

+ support registration activities

+ prepare and support audits and inspections related to area of responsibility



The role involves a significant amount of global interaction and collaboration with the Pfizer Co-Development network, Pharmaceutical Sciences Small Molecules (PSSM), the Process Monitoring, Automation, and Control (PMAC) team, Global CMC, Quality Operations, site colleagues and other stakeholders. This function will also report per dotted reporting line into Quality Operations.



**ROLE RESPONSIBILITIES**



+ Development, Implementation, and Maintenance of Process Analytical and Process Control Technologies

+ Evaluate and implement new technologies and ways of working which enhance the performance of plant unit operations. Support the development and implementation of continuous manufacturing technologies

+ Develop engineering solutions and algorithms for the control of pharmaceutical manufacturing processes (batch and continuous)

+ Develop and implement PAT and Advanced Process Control (APC) applications

+ Develop a detailed understanding of PAT interfaces to processing equipment

+ Structure and process large data sets, and transfer data into process information

+ Support modelling activities. Develop and maintain multivariate and other advanced process and control models, enabling optimized and sustainable pharmaceutical manufacturing processes

+ Incorporate continuous improvement

+ Project Management: Work with international and local project teams

+ Ensure qualification and validation of PAT related control systems

+ Ensure high-quality and GMP compliance of work and documentation

+ Ensure project timelines are met

+ Promote collaborations internally and externally

+ Close collaboration on control technologies with Engineering, Automation, and IT teams

+ Support GMP and safety inspections and audits

+ Support Regulatory Activities by actively participating in the development of control strategies, assisting in the registration process by preparing/reviewing documents and developing query responses

+ Ensure compliance with applicable Environment, Health, and Safety regulations, and take preventive actions



**BASIC QUALIFICATIONS**



+ Scientist with PhD in chemistry, pharmaceutics, physics or related discipline

+ Prior experience in Process Analytical Technology (PAT) and chemical/pharmaceutical process control.

+ Good knowledge of spectroscopy

+ Practical experience in the development and maintenance of multivariate models and process control

+ Good knowledge of chemical or pharmaceutical processing and control technology

+ Knowledge of GMP - ideally, several years of experience working in a cGMP environment.

+ Very good command of German and English language

+ Good collaboration and communication skills, intercultural awareness

+ Attention to detail, strives to meet challenging timelines



**PREFERRED QUALIFICATIONS**



+ Prior experience or understanding of programming, automation, system integration and/or failure modes

+ Knowledge of process automation or robotics

+ Prior exposure to pharmaceutical registration processes



**"** **Breakthroughs** **that** **change** **patients** **'** **lives** **"** - Unser klares Unternehmensziel ist es, Durchbrche zu erreichen, die das Leben von PatienInnen verndern. Sie sind der Sinn unseres Tuns. Wenn Sie Teil dieser Vision sein wollen und die gleiche Leidenschaft teilen, ist Pfizer der ideale Ort, um eine Karriere zu beginnen oder um eine erfolgreich fortzusetzen.



**berzeugt?**

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Pfizer garantiert Chancengleichheit whrend des gesamten Bewerbungsprozesses sowie die Einhaltung der lokalen Gesetzgebungen in den jeweiligen Lndern, in denen Pfizer agiert. Pfizer schliet jegliche diskriminierende Faktoren aus, die u. a. das Geschlecht und Alter, die ethnische Zugehrigkeit, Religion oder Weltanschauung, sexuelle Orientierung oder Behinderung betreffen.



Engineering



\#LI-PFE
Posted: 2021-02-17 Expires: 2021-03-20
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Senior Manager (m/f/d) Process Analytical Technology (PAT) & Automation

Pfizer
Freiburg

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