Senior Manager Process and Technical Development Serialisation

Job Description

CSL Behring – the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.

For our location in King of Prussia, we are looking for a

Senior Manager Process and Technical Development Serialisation

The Senior Manager Process and Technical Development is to provide the technical knowledge and expertise in defining strategies for the further development of serialisation at CSL Behring. Being located in King of Prussia, this position will also play a key role in supporting the supply chain serialisation activities in the Americas, initially those of Commercial Operations USA, and connectivity to supply chain partners and customers, to meet current and upcoming US requirements. The overall regional requirements will be monitored and necessary activities coordinated with Manufacturing Operations together with colleagues from the Serialisation Team who are located at each site of manufacture. Here, a close collaboration with the regional Commercial Operation teams is a must to ensure success.

The position reports to the Director Serialisation and Anti-Counterfeiting and will work closely with the Global Serialisation Team and interact with Site Operations, Site Engineering, Platform Owner Packaging, Regulatory Affairs, Quality, Commercial Operations Americas and Supply Chain Partners in the Americas.

International and domestic travel is required.

Main Responsibilities and Accountabilities:

Serialisation Strategy

* Provide input to and support further development of CSL Behring's serialisation strategy in close collaboration with Global Packaging Operation CSL Behring Site Operations, and Business Technology.

* Work out and explain beneficial future serialisation architecture and aspects of harmonisation.

* Ensure CSL Behring is at the at the front-end of serialisation development:

* Establishing and fostering relationships with Industry Leaders (e.g. GS1, SAP roundtables) and System Providers

* Connecting with other industry leaders' serialisation and anti-counterfeiting specialists and professionals.

* Being a key player in influencing global serialisation developments through keeping on top of technical trends, standards and processes

* Maintain close contact with Commercial Operations and ensure developments are implementable, meet the needs of customers and patients and are compliant with local and global laws and regulations.

* Stay on top of regulatory requirements on technology.

Serialisation Development

* Based on identified strategies with CSL Behring partners also

* Identify changes needed in technical and organizational context, data and serial number management and using background knowledge

* Develop and improve methods, systems and/or procedures with a strong focus on SAP environment and integration of ATTP

* Strive to introduce improvements in operational efficiency as related to serialisation systems, processes and interfaces

* Ensures execution of strategies and developments adhere to plans as agreed and are compliant with CSL Behring's serialisation standards overall standards and policies.

* Ensure documentation of process is maintained and stays up-to-date.

* Subject matter expert for serialization interfaces to packaging control systems and downstream tracking and tracing systems.

Serialisation Operations and Manufacturing Site Support

* Troubleshooting: provide on-time and usable solutions to business critical issues that would otherwise disrupt the product supply process.

* Formal investigation of support issues, communication with impacted stakeholders, vendor, resolution/closure of the issue, and updating appropriate knowledge management records.

* Develop global, repeatable, and logical processes to effectively resolve any issues arising during serialisation operations.

* Maintain close contact with Serialisation Operations at the Sites of Manufacture through regular meetings and communication of technical development.

* Pass on problem-solving methods and tools to Serialisation Operations and mentor staff to improve knowledge and expertise.

* In cooperation with Serialisation Operations and regular contact with the Sites of Manufacture Packaging and Engineering departments develop immediate and long-term enhancements to improve efficiencies in the serialisation processes.

Commercial Operations and Supply Chain Partners Americas

The position holder is to develop the role of supply chain support for serialization in the Americas region, in particular:

* On-site support for Commercial Operations USA regarding customer queries on serialisation

* Point of contact for Supply Chain Partners regarding EDI connectivity to CSL Behring and any serialization process issues

* Point of contact for other CSL Behring affiliates concerning serialization requirements acquisition

Serialisation and Anti-Counterfeiting Management Team

The position holder is a member of the Serialisation and Anti-Counterfeiting Management Team. Activities here will include but are not restricted to

* Budget planning forecasts

* Regular reporting of activities

* Developing strategies for the overall development of the whole Team (e.g. extension of scope of team responsibility)

* Maintenance of communication and cooperation with Global Logistics Operations and Compliance Teams

* Personnel development of team members (below).

Packaging Operations and Anti-counterfeiting initiatives

In addition to the global serialisation strategy and development activities defined above, be a key player and support the Director of Serialisation and Anti-Counterfeiting in the development of further anti-counterfeiting measures to protect both CSL Behring and its patients from potential damage caused by counterfeited CSL Behring products.

* Collaboration with the Global Packaging Operations team that works across sites and organizational boundaries to identify and deliver technologies and equipment to support best practices to the above mentioned strategic manufacturing steps as well as to improve capacity and operational efficiency.

* Provide expertise identifying and recommending state-of-the-art packaging and serialisation technology including MES functionalities.

* Ensure updated knowledge on current best practice and technology for packaging operations and serialisation.

* Drive the development of new technical concepts for packaging and serialisation solutions generally through leverage expert knowledge from the sites and external consultants.

* Ensure that global technical solutions and technologies for packaging and serialisation can be applied at all CSL Behring locations and are consistent with CSL Behring strategic objectives.

* Collect market input on counterfeiting and develop global strategies to counter criminal activities.


* Present and Define and lead projects for the implementation or consolidation of an effective serialization architecture and its impacts of the operational processes, define and plan necessary activities and control progress, risks and dependencies

* Report operational and capital expenses of serialization projects and forecast

* Leads and coordinates site implementation plans with site management, personnel and serialization vendors. Ensure all aspects of implementation are addressed including funding issuance, and change controls. Ensure all site implementation plans follow global serialization implementation strategy.

* Initiate, approve and co-ordinate any anti-counterfeit project or initiative to achieve highest protection levels.

* Support operational excellence and continuous improvement initiatives that have cross site applicability.

Personnel Management

* Provides a source as a known professional knowledge specialist to personally coach and mentor direct reports and to provide career development, across a number of functional areas.

* Work with the Serialisation and Anti-Counterfeiting management team identify talent and development opportunities for all staff.

Qualifications & Experience:

* Degree in Natural Sciences, Engineering or Logistics (Bachelor/Master) or equivalent qualification with a very good proven record in practical, industry experience in the areas listed below.

* 10 + years' experience in a regulated industry, preferably in a pharmaceutical environment with exposure to supply chain, logistics or related disciplines.

* At least 5 years' experience in Enterprise Data Management, with in-depth, practical experience with SAP in Supply Chain / Logistics areas.

* Demonstrated leadership and management capabilities

* Cultural awareness, ability to create good working relationships across countries

* Strong knowledge of Pharmaceutical best practices

* Knowledge of the supply chain, key players, distribution channels, government agencies (national, provincial and local) critical to effective anti-counterfeiting program

* Acts with a sense of urgency and purpose balanced with strategic intent

* German language skills are an advantage

* Ability to manage change in operations and organizations

* Strong project management skills with the ability to manage multiple projects and operational activities simultaneously

* Superior analytical and problem solving skills

* Strong interpersonal and verbal and written communication skills

* Strong negotiation skills

* Good understanding of SAP Supply Chain and Serialization applications

* International and domestic travel is required

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

CSL Behring LLC will provide equal employment opportunity for all persons without discrimination on the basis of membership in a legally protected class, including race, color, religion, national origin, gender, age, veteran status, or handicap/disability.

CSL Behring is committed to ensuring that diversity and inclusion are a part of our everyday business.