Production Manager Drug Product

at  PAION Pharma GmbH

YOUR PROFILE

Post graduate / graduate in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences (at least Master degree or diploma), preferably with a focus on process chemistry.
Professional / Indurstry Experience:
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 manufacturing of pharmaceutical products: process chemistry, process development and validation, manufacturing of Drug Products, manufacturing process lifecycle management, quality control.
Deep-rooted knowledge of GMP requirements and national EU / US regional requirements

Proven knwoledge of / experience in:

• GMP and working within a Quality Management System.
• Managing change controls, deviations
• Commercial manufacturing and on-time manufacture of drug products as technical expert in cooperation with a QA team
• Process validation and commercial manufacturing
• Risk Management

Beneficial:
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 / injectables
Language requirements:
English and German

ABOUT US

PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.
www.paionpharma.com

YOUR TASKS

The Prodcution Manager Drug Product at PAION ensure the supply of drug product to meet PAIONs commercial requirements from the manufacturing / production perspective.
Establishs, maintains and improves the Life Cycle Management of production processes (incl. Continuous Process Improvements, Manufacturing Process Validation Master Plan, etc).
Ensures a proper management of the Manufacturing Specifications

RESPONSIBILITIES / MAIN TASKS

• Review manufacturing documentation and ensure manufacturing activities are conducted in-time and in accordance with current GMP guidelines, PAION specifications and procedures.
• Drawing up of Manufacturing Specifications in coordination with relevant 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 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.
• Ensure overall compliance with ICH requirements, especially ICH Q3, ICH Q7, ICH Q8, ICH Q9, ICH Q11, ICH Q12
• Manage Drug Product materials together with Supply Chain and external partners
• Manage production related change controls and deviations internally as well as externally with vendors.
• Provide support to licensees in production related topics where applicable, including the organisation and support of manufacturing process transfer programs
• 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 registration documentation
• General management and control of external vendors as well as the 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 internal procedures.