Production Manager API (m/f/d)

Permanent employee, Full-time · Aachen

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Deine Aufgaben
  • Together with PAION QA, review manufacturing documentation and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, PAION specifications and PAION procedures
  • Drawing up of Manufacturing Specifications in coordination with relevant PAION departments and CMOs
  • Support drawing up and review other relevant specifications, e.g., release specifications
  • Perform Life Cycle Management and Continuous Improvement of manufacturing processes by establishing and executing a manufacturing process validation master plan and follow up of required periodical and ad-hoc measures in cooperation with other departments and PAIONs CMOs
  • Review and update / improve manufacturing processes as appropriate, including changes / updates of EU GMP guidelines and GMP guidelines of other territories in the interest of PAION (for example territories of licensees)
  • Ensure overall compliance of PAION with ICH requirements, especially ICH Q3, ICH Q7, ICH Q8, ICH Q9, ICH Q11, ICH Q12
  • Manage API and Drug Product materials together with Supply Chain and external partners
  • Manage production related change controls and deviations internally as well as externally with PAIONs vendors
  • Provide support to PAION’s licensees in production related topics where applicable, including the organisation and support of manufacturing process transfer programs if applicable
  • Draw up, review and maintain internal and external production-related documents i.e., validation reports, risk assessments, master and executed batch records, as well as SOPs
  • Provide technical support with the drawing up and maintenance of PAION's registration documentation
  • General management and control of external vendors of PAION and co-ordination of interactions with these vendors in all production related topics
  • Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelines and PAION procedures
  • Occasional travel
Dein Profil
  • At least Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences, preferably with a focus on process chemistry
  • At least 5 years practical industrial experience working in pharmaceutical or biotechnology industries and in three or more of the following areas associated with industrialization and 2 manufacturing of pharmaceutical products: process chemistry, process development and validation, manufacturing of APIs, manufacturing process lifecycle management, quality control
  • Deep-rooted knowledge of GMP requirements, including ICH requirements and national EU / US regional requirements
  • Proven knowledge of Good Manufacturing Practises and of working within a Quality Management System. Experience in managing change controls and deviations.
  • Proven Experience with commercial manufacturing and on-time manufacture of API and Drug Products as technical expert in cooperation with a QA team
  • Proven knowledge of process validation and commercial manufacture
  • Knowledge of risk management
  • Fluency in English und in German
Desirable skills:
  • Knowledge of additional national regulatory requirements outside EU / US (e.g. Japan, Korea, Brazil) as well as their national GMP and manufacturing requirements
  • Experience of technical managements and direction of external vendors would be extremely beneficial as the company works with a network of vendors
  • Manufacturing of sterile products
Warum wir?
  • A permanent position with an innovative employer 
  • A great deal of creative freedom and career opportunities
  • 30 days vacation and trust-based working hours 
  • Short communication channels, open doors and helpful, committed colleagues
  • Flexible working hours with partial home office for a good work-life-balance
  • State-of-the-art IT equipment with Dell equipment and Apple iPhones
  • A brand new office with employee showers for athletes and underground parking spaces in Aachen in a very good location directly on the A44 freeway
  • Daily fresh fruit basket, free coffee, tea and water
Über uns
PAION, mit Sitz in Aachen, Deutschland, ist ein börsennotiertes Specialty-Pharma-Unternehmen mit  innovativen Wirkstoffen zur Anwendung bei ambulanter und im Krankenhaus durchgeführter Sedierung, Anästhesie sowie in der Intensivmedizin. 

PAION's Mission ist es, ein führendes  Specialty-Pharma-Unternehmen in den Bereichen Anästhesie und Intensivmedizin zu  sein, indem wir neuartige Produkte auf den Markt bringen, die Patienten, Ärzten und anderen Stakeholdern im Gesundheitswesen zugutekommen.
Your tasks
We are looking for a candidate trained as a chemist with at least 3 years of experience in the field of API production. Experience in the pharmaceutical industry is not a must, but a plus. With the possibility of home offices, we have a certain flexibility in terms of location.

Your  varied tasks - This is what awaits you with us:      
     
  • Together with PAION QA, review manufacturing documentation and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, PAION specifications and PAION procedures
  • Drawing up of Manufacturing Specifications in coordination with relevant PAION departments and CMOs
  • Support drawing up and review other relevant specifications, e.g., release specifications
  • Perform Life Cycle Management and Continuous Improvement of manufacturing processes by establishing and executing a manufacturing process validation master plan and follow up of required periodical and ad-hoc measures in cooperation with other departments and PAIONs CMOs
  • Review and update / improve manufacturing processes as appropriate, including changes / updates of EU GMP guidelines and GMP guidelines of other territories in the interest of PAION (for example territories of licensees)
  • Ensure overall compliance of PAION with ICH requirements, especially ICH Q3, ICH Q7, ICH Q8, ICH Q9, ICH Q11, ICH Q12
  • Manage API and Drug Product materials together with Supply Chain and external partners
  • Manage production related change controls and deviations internally as well as externally with PAIONs vendors
  • Provide support to PAION’s licensees in production related topics where applicable, including the organisation and support of manufacturing process transfer programs if applicable
  • Draw up, review and maintain internal and external production-related documents i.e., validation reports, risk assessments, master and executed batch records, as well as SOPs
  • Provide technical support with the drawing up and maintenance of PAION's registration documentation
  • General management and control of external vendors of PAION and co-ordination of interactions with these vendors in all production related topics
  • Provision of subject matter expertise to support audit of manufacturing / testing facilities in accordance with GMP, current guidelines and PAION procedures
  • Occasional travel
Your profile
  • At least Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences, preferably with a      focus on process chemistry  
  • At least 3 years practical industrial experience      working in pharmaceutical or biotechnology industries and in two or more      of the following areas associated with industrialization and manufacturing      of pharmaceutical products: process chemistry, process development and      validation, manufacturing of APIs, manufacturing process lifecycle      management, quality control 
  • Proven knowledge of GMP requirements, including ICH requirements and national EU / US regional requirements  
  • Proven knowledge of Good Manufacturing Practises and of working within a Quality Management System. Experience in managing change controls and deviations 
  • Experience with commercial manufacturing and on-time manufacture of API and Drug Products as technical expert in cooperation with a QA team  
  • Experience in process validation
  • Knowledge of risk management  
  • Fluency in English und in German 
           
      Desirable skills:
  • Knowledge of additional national regulatory requirements outside EU / US (e.g. Japan, Korea, Brazil) as well as their national GMP and manufacturing requirements
  • Experience of technical managements and direction of external vendors would be extremely beneficial as the company works with a network of vendors
  • Manufacturing of sterile products
Why us?
  • A permanent position with an innovative employer in secure, economic circumstances (even during the Covid crisis)  
  • A steep learning curve, rapid personal and professional development
  • A great deal of creative freedom and attractive career opportunities  
  • Attractive remuneration and company pension scheme  
  • 30 days' holiday and trust-based working hours  
  • Short communication channels, open doors and helpful, committed colleagues  
  • Flexible working hours with partial home office for a good work-life balance  
  • Superb onboarding, including intensive induction training  
  • State-of-the-art IT equipment with Dell equipment and Apple iPhones  
  • A brand new office with employee showers for      athletes and underground parking spaces in Aachen in a very good location directly on the A44 motorway
  • Daily  fresh fruit basket, free coffee, tea and water  
About us
PAION with its headquarter in Aachen,  Germany, is a publicly listed specialty pharmaceutical company with innovative  drugs to be used in hospital-based sedation, anesthesia and critical care  services.

Our mission is to be a  leading specialty pharmaceutical company in the fields of anesthesia and  critical care by bringing novel products to market to benefit patients, doctors  and other stakeholders in healthcare.
We are looking forward to hearing from you!
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